The House Oversight and Accountability Committee is setting its sights on the Biden administration&#8217;s mishandling of the <a href="https://www.dailywire.com/topic/baby-formula-shortage" target="_blank" rel="noopener">baby formula shortage</a> of 2022.
Oversight Committee Chairman Rep. <a href="https://www.dailywire.com/topic/james-comer" target="_blank" rel="noopener">James Comer</a> (R-KY) and Subcommittee on Health Care and Financial Services Chairwoman Rep. Lisa McClain (R-MI) sent a <a href="https://oversight.house.gov/wp-content/uploads/2023/03/Letter-to-FDA-re-Restructure-and-baby-formula-118th.pdf" target="_blank" rel="noopener">letter</a> to FDA Commissioner Dr. Robert Califf requesting documents related to the government&#8217;s response to the nationwide baby formula shortage. The two lawmakers blasted the FDA for not taking any real accountability for mishandling the crisis.
&#8220;The Committee on Oversight and Accountability is continuing its investigation into the U.S. Food and Drug Administration’s (FDA) response to the infant formula shortage and its restructuring of the food and nutrition division in response to the infant formula shortage,&#8221; the two lawmakers wrote in their letter. &#8220;The Reagan-Udall Foundation’s report titled &#8216;<a href="https://reaganudall.org/sites/default/files/2022-12/Human%20Foods%20Program%20Independent%20Expert%20Panel%20Final%20Report%20120622.pdf" target="_blank" rel="noopener">Operational Evaluation of the FDA Human Foods Program</a>,&#8217; found that there was ‘little motivation, and no requirement,’ to ‘facilitate critical thinking and proactive decision-making’ during the infant formula shortage. Despite this report, and the acknowledged need for a major overhaul, you stated that there would be no reassignments nor firings over the administration’s response to the infant formula shortage.&#8221;
Comer and McClain also blasted the FDA for shuffling around the food safety and nutrition division instead of firing or reassigning the employees who mishandled the crisis, or taking any kind of real accountability. &#8220;As the administration scrambled to contain the issue, families across the nation were presented with the question of how they would feed the infants in their families and communities,&#8221; the lawmakers wrote. &#8220;Now, instead of removing or reassigning the individuals at fault for the poor response to this crisis, the announced restructuring of the food and nutrition division simply requires certain offices and personnel to report to the newly created position of Deputy Commissioner for Human Foods. The Committee is concerned that the FDA’s restructuring is a superficial attempt—rather than a real effort—to bring accountability and make meaningful changes.&#8221;
The Committee then demanded that the FDA turn over a trove of documents related to the crisis, including documents and communications:
<ul>
<li>Between the White House and the FDA and the Department of Health and Human Services related to the shortage;</li>
<li>About the FDA&#8217;s reorganization plan for the food safety and nutrition division;</li>
<li>The selection process for a Deputy Commissioner for Human Foods;</li>
<li>The decision not to fire or reassign any individual involved in the response;</li>
<li>Outlining the procedures transitioning those units affected by the reorganization;</li>
<li>Outlining the timeline for implementation of the reorganization.</li>
</ul>
The committee demanded all documents before April 4.
<a class="c-link c-link--focus-visible" href="https://onelink.to/dwapp" target="_blank" rel="noopener noreferrer" data-stringify-link="https://onelink.to/dwapp" data-sk="tooltip_parent" aria-describedby="sk-tooltip-441512">CLICK HERE TO GET THE DAILY WIRE APP</a>
News of the nationwide shortage of baby formula began in early 2022. President Joe Biden said he had been aware of the shortage since early <a href="https://www.dailywire.com/news/biden-says-he-became-aware-of-baby-formula-shortage-in-early-april" target="_blank" rel="noopener">April</a>, and HHS Secretary <a href="https://www.dailywire.com/news/top-biden-official-claims-administration-knew-about-baby-formula-shortage-last-year" target="_blank" rel="noopener">Xavier Becerra</a> said the administration had known about it since 2021; but no one in the administration publicly addressed it until May 2022. President Joe Biden was forced to import formula from foreign countries in an effort to get product on store shelves.
Families are still feeling the effects of the shortage, nearly a year after it began. According to a report from <a href="https://www.theguardian.com/us-news/2023/mar/08/us-baby-formula-shortage-one-year-later" target="_blank" rel="noopener">The Guardian</a> earlier this month, shelves are still empty in some areas and certain brands are out of stock or limited, while the companies that make formula are facing scrutiny from federal regulators and investigators.

Baby formula

House Oversight Committee Investigating Biden Administration Mishandling Of Baby Formula Shortage

baby formula shortage

Biden Administration

Congress

House Republicans

James Comer

Politics

The Food and Drug Administration (<a href="https://www.dailywire.com/topic/fda" target="_blank" rel="noopener">FDA</a>) announced Friday that it will remove a restriction on <a href="https://www.dailywire.com/topic/lgbtq" target="_blank" rel="noopener">gay and bisexual men</a> donating blood, a segment of the population that faces a higher risk of HIV.
According to draft guidelines announced by the FDA, the new policy would eliminate a requirement that gay and bisexual men abstain from sexual activity for three months before donating blood, the Associated Press <a href="https://apnews.com/article/health-us-food-and-drug-administration-lgbtq-people-canada-blood-donation-9c11389da42c14ac2e80366f271aa1b7?utm_source=homepage&amp;utm_medium=TopNews&amp;utm_campaign=position_09" target="_blank" rel="noopener">reported</a>. The proposed rule change would be a major shift in a decades-old policy set during the AIDS crisis of the 1980s. 
Instead of requiring three months of abstinence for men who have sex with men, the FDA will make all potential donors fill out a personalized questionnaire that evaluates each person’s risks for HIV before they can donate blood.
“We will continue to work to make sure we have policies that allow everyone who wants to donate blood to be able to donate blood, within what the science allows to keep the blood supply safe,” <a href="https://www.wsj.com/articles/fda-to-allow-more-gay-bisexual-men-to-donate-blood-11674829119" target="_blank" rel="noopener">said</a> the FDA&#8217;s Peter Marks, according to The Wall Street Journal.
During the 1980s AIDS crisis, the U.S. barred gay men from donating blood in an effort to prevent the spread of HIV, the sexually-transmitted virus that can <a href="https://www.cdc.gov/hiv/basics/whatishiv.html" target="_blank" rel="noopener">lead</a> to AIDS if not treated before it develops. Gay and bisexual men account for nearly 70% of all new HIV diagnoses in the U.S., according to 2019 <a href="https://www.cdc.gov/hiv/group/msm/msm-content/diagnoses.html" target="_blank" rel="noopener">data</a> from the Centers for Disease Control and Prevention.
The FDA’s newly drafted guidance comes after medical associations have said that technological advancements in testing have made the extra requirements for gay and bisexual men unnecessary. The move also comes after continued calls for change from LGBTQ advocates.
The FDA <a href="https://www.wsj.com/articles/fda-to-lift-lifetime-ban-on-blood-donations-from-gay-men-1419360922?mod=article_inline" target="_blank" rel="noopener">lifted</a> the complete ban on gay men donating blood in 2015, requiring them to abstain from same-sex intercourse for a full year before donating. Then, the FDA dropped the abstinence period for blood donations from gay men to three months as the country grappled with a blood shortage <a href="https://www.redcross.org/about-us/news-and-events/news/2022/2022-crisis-response-donors-roll-up-their-sleeves-to-end-crisis.html#:~:text=In%20January%202022%2C%20the%20American,of%20the%20COVID%2D19%20pandemic." target="_blank" rel="noopener">resulting</a> from complications of the COVID pandemic, the Journal reported.
Carl Schmid, executive director of the HIV+Hepatitis Policy Institute, told the Journal that the newest change in the FDA’s guidelines “marks a monumental shift and ends a long and painful era of blanket discrimination against gay men.”
The FDA’s updated guidelines will continue to bar those who have tested positive for HIV and those who are taking HIV medication from donating blood, and blood donation centers must test all blood for HIV and other diseases.

Midsection Of Man Donating Blood

FDA To Remove Restriction On Blood Donations From Gay, Bisexual Men

Health

LGBTQ

Medical

U.S.

The Food and Drug Administration (<a href="https://www.dailywire.com/topic/fda" target="_blank" rel="noopener">FDA</a>) <a href="https://www.nytimes.com/2023/01/26/health/fda-cbd-oversight.html" target="_blank" rel="noopener">said</a> <a href="https://apnews.com/article/health-us-food-and-drug-administration-pain-management-business-marijuana-6c3fd2910c18e5929ae4fa4ec4f62444" target="_blank" rel="noopener">Thursday</a> that updated regulations are needed for cannabidiol (CBD) and congress should create a path for such rules. 
In a statement on Thursday, FDA Deputy Commissioner Dr. Janet Woodcock <a href="https://www.fda.gov/news-events/press-announcements/fda-concludes-existing-regulatory-frameworks-foods-and-supplements-are-not-appropriate-cannabidiol" target="_blank" rel="noopener">said</a> that new regulations are necessary for <a href="https://www.mayoclinic.org/healthy-lifestyle/consumer-health/expert-answers/is-cbd-safe-and-effective/faq-20446700" target="_blank" rel="noopener">CBD</a>, which is a chemical in <a href="https://www.dailywire.com/topic/marijuana" target="_blank" rel="noopener">marijuana</a> and does not include tetrahydrocannabinol (THC), which causes users to experience a high.
Woodcock said that the agency is ready to work with the United States Congress to establish a new regulation process for CBD. The agency also refused to accept three petitions from people that had asked the FDA to create rules to permit CBD items to be sold as dietary supplements.
The FDA regulates the medication <a href="https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-comprised-active-ingredient-derived-marijuana-treat-rare-severe-forms" target="_blank" rel="noopener">Epidiolex</a>, which has CBD in it and was the first medicine that the agency approved that had active drug material that came from marijuana. However, the agency said that a group looked at studies connected to Epidiolex, as well as other research, and decided that it is not clear how CBD items “could meet safety standards for dietary supplements or food additives.”
&#8220;For example, we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm,&#8221; the statement noted.
The Washington Post <a href="https://www.washingtonpost.com/business/2023/01/26/cbd-fda-safety/" target="_blank" rel="noopener">reported</a> that federal law holds that the active compounds used in prescription medication can’t also be food supplements. The FDA does not have much capability to increase the spread of CBD because of the existence of the medication, according to Peter Lurie, executive director at the Center for Science in the Public Interest.
Using CBD, especially for a long amount of time, brings up questions about its safety, Woodcock’s statement noted. Research has revealed that it can possibly damage the liver, and could damage the male reproductive system. It can also react with specific medicines and could be an issue if pregnant women or children come into contact with it.
The agency is not planning to attempt to make regulations for CBD to be used in foods or dietary supplements. It also pointed out that the substance could be harmful to animals and consumers could accidentally come into contact with CBD through food products that are made from animals that eat CBD. The agency is also not going to make rules permitting CBD to be used in feed for animals.
State regulations differ on the substance. Some <a href="https://www.forbes.com/health/body/cbd-legalization-by-state/" target="_blank" rel="noopener">states</a> allow it to be used entirely, whereas others put certain parameters on it.
“I’m sure the FDA probably concluded that no matter which way they went, it would involve trying to fit a very big genie back into a very small bottle, and create a political firestorm,” Brian Ronholm, Director of Food Policy for Consumer Reports, <a href="https://www.washingtonpost.com/business/2023/01/26/cbd-fda-safety/" target="_blank" rel="noopener">said</a>. “It’s not surprising that they would want to seek some cover from Congress.”

ACD8A49D-63EA-4004-A005-71E101ED0D1B_1_105_c

FDA Questions Safety Of CBD, Says It Is Ready To Work With Congress On Regulation

Big Pharma

Republican South Dakota Gov. Kristi Noem and Attorney General Marty Jackley sent a letter to pharmacists in their state warning that they will be subject to felony prosecution if they dispense abortion pills in their state.
The joint letter was sent on Tuesday following changes by the Food and Drug Administration (FDA) stating that it will certify retail pharmacies to prescribe popular medications used in chemical abortions.
“Chemical abortions remain illegal in South Dakota. Under South Dakota law, pharmacies, including chain drug stores, are prohibited from procuring and dispensing abortion-inducing drugs with the intent to induce an abortion, and are subject to felony prosecution under South Dakota law, despite the recent FDA ruling,&#8221; the letter <a href="https://governor.sd.gov/doc/GovNoem_AGJackley_Letter-to-Pharmacists.pdf" target="_blank" rel="noopener">stated</a>. &#8220;Their resources should be focused on helping mothers and their babies, both before birth and after.&#8221;
After the Supreme Court&#8217;s Dobbs decision in June 2022 to return abortion laws to individual states, South Dakota&#8217;s 2005 trigger law went into effect that made abortions illegal in the state except to save the life of the mother, <a href="https://news.sd.gov/news?id=news_kb_article_view&amp;sys_id=8d8bf9121b602510b04d4262f54bcb40" target="_blank" rel="noopener">according to</a> a statement from Noem&#8217;s office.
Noem announced a new website, <a href="https://life.sd.gov/" target="_blank" rel="noopener">Life.SD.gov</a>, last year to promote &#8220;helping mothers and babies before and after birth&#8221; as part of the state&#8217;s pro-life focus.
“All abortions, whether surgically or chemically induced, terminate the life of a living human being,&#8221; Noem and Jackley added in the letter. &#8220;South Dakota will continue to enforce all laws including those that respect and protect the lives of the unborn. We trust pharmacists doing business in this state will take the same approach to respecting life.”
At least two other states, Florida and Alabama, have offered similar warnings to pharmacists in their states.
The Florida Agency for Healthcare Administration <a href="https://www.cbsnews.com/miami/news/florida-agency-for-healthcare-administration-warns-pharmacies-to-not-give-out-abortion-pills/" target="_blank" rel="noopener">sent</a> a letter following the FDA&#8217;s change warning pharmacies against dispensing abortion pills, citing state law that &#8220;no termination shall be performed at any time except by a licensed physician.&#8221;
In Alabama, Attorney General Steve Marshall even noted that women could be prosecuted for using abortion pills, despite the state’s law only criminalizing abortion providers and preventing prosecution against women who have abortions.
“The Human Life Protection Act targets abortion providers, exempting women ‘upon whom an abortion is performed or attempted to be performed’ from liability under the law,” Marshall said in a <a href="https://www.al.com/news/2023/01/women-can-be-prosecuted-for-taking-abortion-pills-says-alabama-attorney-general.html" target="_blank" rel="noopener">statement</a> to AL.com. “It does not provide an across-the-board exemption from all criminal laws, including the chemical-endangerment law—which the Alabama Supreme Court has affirmed and reaffirmed protects unborn children.”
The FDA&#8217;s policy update earlier this month was followed by President Joe Biden issuing a presidential memorandum on Sunday to protect access to abortion pills to mark 50 years since the Supreme Court’s Roe v. Wade decision.
&#8220;My Administration remains committed to supporting safe access to mifepristone, consistent with applicable law, and defending women’s fundamental freedoms,&#8221; Biden <a href="https://www.whitehouse.gov/briefing-room/presidential-actions/2023/01/22/memorandum-on-further-efforts-to-protect-access-to-reproductive-healthcare-services/" target="_blank" rel="noopener">said</a> in the Sunday memorandum. &#8220;Defending and protecting reproductive rights is essential to our Nation’s health, safety, and progress. It is the policy of my Administration to protect against threats to the liberty and autonomy of those who live in this country.&#8221;
The FDA change on abortion pill access led to a group of 22 attorneys general sending a letter to FDA Commissioner Dr. Robert Califf asking the agency to reverse its decision. The letter, led by Alabama Attorney General Steve Marshall, argued that the distribution of abortion-inducing drugs poses a danger to women’s health.
“The Food and Drug Administration’s decision to abandon commonsense restrictions on remotely prescribing and administering abortion-inducing drugs is both illegal and dangerous,” the <a href="https://www.scribd.com/document/619779306/Letter-From-Alabama-Attorney-General-Steve-Marshall-to-FDA-about-abortion-pill-rule-change#" target="_blank" rel="noopener">letter</a> read. “In direct contravention of longstanding FDA practice and congressional mandate, the FDA’s rollback of important safety restrictions ignores both women’s health and straightforward federal statutes. We urge you to reverse your decision.”

Kristi Noem

‘Subject To Felony Prosecution’: Gov. Kristi Noem Warns South Dakota Pharmacists Against Dispensing Abortion Pills

Gov. Kristi Noem Warns South Dakota Pharmacists Against Dispensing Abortion Pills

Abortion

Pro-Life Movement

South Dakota

The Food and Drug Administration (<a href="https://www.dailywire.com/topic/fda" target="_blank" rel="noopener">FDA</a>) <a href="https://thehill.com/policy/healthcare/3828442-fda-issues-guidance-to-reduce-lead-exposure-in-baby-food/" target="_blank" rel="noopener">released</a> draft guidelines on Tuesday regarding levels of lead in certain baby and children’s food products.
The <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-action-levels-lead-food-intended-babies-and-young-children" target="_blank" rel="noopener">guidance</a> is for foods that are meant for infants and young kids under the age of two and that are processed, like those that are kept in certain types of packaging, the agency noted.
The action levels from the FDA include 10 parts per billion for specific produce, like vegetables and fruits, as well as mixes, meats that are one ingredient, custards or puddings, and yogurts. For root vegetables that are one ingredient, the levels are 20 parts per billion, and dry cereals’ levels are also 20 parts per billion.
“For more than 30 years, the FDA has been working to reduce exposure to lead, and other environmental contaminants, from foods. This work has resulted in a dramatic decline in lead exposure from foods since the mid-1980s,” FDA Commissioner Robert M. Califf <a href="https://www.fda.gov/news-events/press-announcements/fda-announces-action-levels-lead-categories-processed-baby-foods" target="_blank" rel="noopener">said</a>.
“For babies and young children who eat the foods covered in today’s draft guidance, the FDA estimates that these action levels could result in as much as a 24-27% reduction in exposure to lead from these foods,” Califf added.
When deciding on the levels, the agency took into account, with other items, the amount of lead that could be in a food item with no exposure from eating it surpassing the agency’s Interim Reference Level. It also pointed out that produce and grains naturally take in nutrients, but they can also bring on harmful materials.
The agency noted that the guidelines are not binding, but it would take the levels into consideration, along with other items, when deciding whether to “bring enforcement action” in certain situations. It also anticipates that the recommendations will push the makers of these products to bring the amount of lead in their items under the action levels set forth.
“The action levels in today’s draft guidance are not intended to direct consumers in making food choices. To support child growth and development, we recommend parents and caregivers feed children a varied and nutrient-dense diet across and within the main food groups of vegetables, fruits, grains, dairy and protein foods,” said Susan Mayne, the FDA’s Center for Food Safety and Applied Nutrition director.
“This approach helps your children get important nutrients and may reduce potential harmful effects from exposure to contaminants from foods that take up contaminants from the environment,” Mayne added.
Some noted that the guidelines weren’t quite good enough to do much.
“Nearly all baby foods on the market already comply with what they have proposed,” Jane Houlihan, the National Director of Science and Health at Healthy Babies Bright Futures, <a href="https://www.cnn.com/2023/01/24/health/baby-food-lead-levels-fda-wellness/index.html" target="_blank" rel="noopener">said</a>.
Consumer Reports noted that the FDA didn’t recommend levels for “baby junk food,” which it claimed can, many times, have the most lead.
“It appears that the proposed standards were set based more on current industry feasibility to achieve the limits and not solely on levels that would best protect public health,” Brian Ronholm, Consumer Reports’ director of food policy <a href="https://www.wsj.com/articles/fda-proposes-limits-for-lead-in-baby-food-11674588483?mod=hp_listb_pos3" target="_blank" rel="noopener">said</a>.

Three baby spoons of baby puree isolated on white from above – stock photo Green, yellow and orange baby puree in baby spoon isolated on white background, top view

FDA Releases Draft Guidance On Lead Levels In Baby Food

Children

Children's Health

This article is a companion piece to today’s Morning Wire Afternoon Update. To listen to the podcast version, click <a href="https://www.dailywire.com/podcasts/morning-wire" target="_blank" rel="noopener">here</a>.
Lindsey Graham Defends Biden
Amidst the fallout from the classified documents scandal, President Joe Biden received a statement of support from his friend Republican Senator Lindsey Graham, who told the media that he did not suspect any purposeful wrongdoing by the president.
<blockquote class="twitter-tweet" data-width="500" data-dnt="true">
Here&#39;s the video: <a href="https://t.co/6QJI5N05aV">pic.twitter.com/6QJI5N05aV</a>
&mdash; Ahtra Elnashar (@AhtraElnashar) <a href="https://twitter.com/AhtraElnashar/status/1617920575342800897?ref_src=twsrc%5Etfw">January 24, 2023</a></blockquote>
<script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>
Classified Docs Found At Pence&#8217;s Home
And, on Tuesday, an attorney for former Vice President Mike Pence <a href="https://www.dailywire.com/news/report-classified-documents-found-at-former-vp-mike-pences-home-in-indiana" target="_blank" rel="noopener">announced</a> that classified documents have also been found in his home in Indiana. Pence’s attorney said that his team notified the National Archives of the documents on January 18 after the discovery two days prior. Per protocol, the National Archives notified the FBI, which then searched the home last Thursday. Sources told CNN that the documents appear to have been inadvertently packed up from his vice presidential office and transported to his home without Pence’s knowledge.
Another California Mass Shooting Leaves 7 Dead Monday
A mass shooting in Half Moon Bay, California, on Monday, left seven people dead and another injured. Authorities say the suspect is a 66-year-old farm worker who opened fire on other migrants at two separate locations. Law enforcement says they believe the shooting may have been “workplace violence” — and that the suspect was employed at the first location, formerly known as the Mountain Mushroom Farm.
Republicans Vow To Investigate Penn Biden Center And Hunter&#8217;s Artwork
Republican House Oversight Committee Chairman James Comer (R-KY) <a href="https://www.dailywire.com/news/house-gop-will-trace-the-money-flowing-into-penn-biden-center-hunter-biden-art-sales-comer-says" target="_blank" rel="noopener">said</a> this week that he intends to investigate donations to the Penn Biden Center, as well as who is purchasing Hunter Biden’s artwork as part of a probe into the Biden family’s financial ties. Comer has already sent requests for documents and other information to the White House, the University of Pennsylvania, Treasury Secretary Janet Yellen, and others. He is planning more requests in the future and said he’s willing to subpoena information if he must.
DOJ Sues Google
The Department of Justice <a href="https://www.dailywire.com/news/doj-to-file-antitrust-suit-against-google-alleging-digital-ad-monopoly-report-says" target="_blank" rel="noopener">sued</a> Google over the company’s dominance in the digital advertising space. The DOJ&#8217;s lawsuit is the latest in a series of antitrust cases made against the company by federal and state government entities.
Trial Begins For Mark Houck, The Catholic Pro-Life Activist Biden’s DOJ Wants Behind Bars
The trial for Mark Houck, the Catholic father of seven and pro-life activist <a href="https://www.dailywire.com/news/trial-begins-for-mark-houck-the-catholic-pro-life-activist-bidens-doj-wants-behind-bars" target="_blank" rel="noopener">arrested</a> by the FBI last year, began on Tuesday. Houck is accused of violating the FACE act after he allegedly shoved a clinic escort to the ground after the escort allegedly hassled his son. Houck is facing 11 years behind bars and hundreds of thousands of dollars in fines if convicted. An attorney for Houck has called the case clear “political prosecution.”
FDA Considers New COVID Guidelines
The FDA is considering new, simplified COVID vaccine guidelines. The recommendation is that <a href="https://www.dailywire.com/news/fda-committee-to-meet-over-covid-shots" target="_blank" rel="noopener">healthy adults</a> and children get a shot once a year. The proposal will be considered by a panel of vaccine experts on Thursday.
Four Illegal Aliens Charged With Stealing Thousands From NYC Macy&#8217;s 
Four migrants <a href="https://www.dailywire.com/news/four-migrants-bused-to-nyc-arrested-in-12k-theft-from-macys" target="_blank" rel="noopener">bused</a> to New York City from Texas were arrested for allegedly stealing more than $12,000 in items from Macy’s. The migrants were detained after being tracked down by Nassau County Police. They allegedly drove away from the crime scene on in a 2006 BMW with a false license plate.
Taylor Swift Protest At U.S. Capitol
Taylor Swift fans <a href="https://www.dailywire.com/news/twitter-loses-it-over-senators-quoting-taylor-swift-songs-at-ticketmaster-hearing" target="_blank" rel="noopener">protested</a> at the Capitol today where the Senate Judiciary Committee held a hearing into Live Nation and the lack of competition in the ticketing industry. This comes after years of complaints about high fees and murky resale practices. The so-called “Swifties” are the company’s most vocal critics. Attorneys general of several states launched consumer protection investigations, while many lawmakers called for Ticketmaster to be broken up, and dozens of Swift fans have sued the company for fraud and antitrust violations.
Oscar Nominations Announced
Oscar nominations <a href="https://www.dailywire.com/news/oscar-nominees-announced-everything-everywhere-all-at-once-leads-with-11" target="_blank" rel="noopener">were announced today</a> in Los Angeles. including a few nods to notable blockbusters. “Everything Everywhere All at Once” had the most nominations with 11, including a Best Picture nod. The other nominees in that category: “All Quiet on the Western Front,” “Avatar: The Way of Water,” “Elvis,” “The Fabelmans,” “Triangle of Sadness,” “Women Talking,” and “Top Gun: Maverick.” The awards show will be held on March 12.
To listen to the audio version of this podcast, <a href="https://podcasts.apple.com/us/podcast/morning-wire/id1576594336" target="_blank" rel="noopener">click here</a>. And for more in-depth discussion of the biggest stories of the day, listen to the latest full episode of Morning Wire every morning.

TUESDAY

Tuesday Afternoon Update: Lindsey Graham Defends Biden, Report Says Pence Has Classified Docs, Corruption In Ukraine?

California

General

Hollywood

Joe Biden

Lindsey Graham

Mike Pence

Morning Wire

A committee with the <a href="https://www.dailywire.com/topic/fda" target="_blank" rel="noopener">Food and Drug Administration</a> (FDA) is set to <a href="https://thehill.com/policy/healthcare/3826608-fda-panel-to-consider-annual-covid-19-vaccine-shots/" target="_blank" rel="noopener">meet</a> this week regarding COVID vaccinations and recommendations for the future. 
On Thursday, the Vaccines and Related Biological Products Advisory Committee Meeting will <a href="https://www.cnbc.com/2023/01/23/covid-fda-says-most-people-probably-only-need-shot-moving-forward.html" target="_blank" rel="noopener">meet</a> to discuss various steps with regard to COVID vaccinations. 
In a briefing <a href="https://www.fda.gov/media/164699/download" target="_blank" rel="noopener">document</a> regarding the meeting, the FDA said that it is hoping the committee will think about several items, including making the immunization schedule easier by giving specific kids, immunocompromised people, and older people two shots, but only one to other people. It also wants the panel to think about making a system for vaccination recommendations akin to the way the flu shot is handled every year. 
The document pointed out that the mRNA bivalent booster shots’ rollout “has been associated with significant implementation complexities,” adding that because of this and other available information, “a move to a single vaccine composition for primary and booster vaccinations should be considered.”
Most people might only need to get one shot to be protected for a certain time, due to what is known about vaccination and previous exposure to the virus, the document stated. It also said that young people who may not have been exposed to COVID, as well as older people and those with compromised immune systems, might need to get two. 
It also noted that the agency expects to carry out a review of “SARS-CoV-2 strains” at least every year and to ask the panel around June of every year about “strain selection for the fall season.” Then, a recommendation for the vaccine composition would be chosen and created to be ready by the fall — “no later than September of each calendar year.”
The numbers seem to imply that the COVID booster shots were not entirely popular last year.
A Morning Consult <a href="https://morningconsult.com/2022/12/01/covid-19-vaccines-booster-shot-survey-data/" target="_blank" rel="noopener">report</a> from December showed that 53% of American adults were going to get a booster in the year to come, but that was a decrease of 5% since a similar poll from September. In addition, 47% of vaccinated American adults who didn’t get a booster in the fall said they weren’t going to get the new bivalent booster. 
Over 40% of those who hadn’t gotten the bivalent booster for Omicron also said a reason they didn’t get it was that they didn’t understand a point in getting an additional shot on top of other COVID vaccines. A similar percentage listed not being concerned about getting COVID anymore as a reason to not get another shot.
Interest in getting the booster last year was slow to start, as well. Only 3.6% of eligible individuals had gotten the updated <a href="https://www.nbcnews.com/health/health-news/updated-covid-booster-shots-doses-administered-cdc-rcna48960" target="_blank" rel="noopener">booster</a> in the early weeks of its availability. 
The most recent data <a href="https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-people-booster-percent-total" target="_blank" rel="noopener">published</a> by the CDC showed that only 15.3% of the entire United States population has gotten the bivalent booster dose.

E49CA65B-F34A-4C2A-A187-E793D4003498_1_105_c

FDA Committee To Meet Over COVID Shots

COVID

COVID-19 Vaccine

New York City Mayor <a href="https://www.dailywire.com/topic/eric-adams" target="_blank" rel="noopener">Eric Adams</a> said Tuesday that four city-run health clinics would offer free abortion pills as early as tomorrow in an outlined so-called agenda for &#8220;women&#8217;s health&#8221; across the five boroughs.
&#8220;For too long, health and health care has been centered around men,&#8221; Adams said in a <a href="https://www.nyc.gov/office-of-the-mayor/news/037-23/mayor-adams-commits-making-new-york-city-future-women-s-health#/0" target="_blank" rel="noopener">news release</a>. “If men had periods, pap smears and menopause, they would get a paid vacation. And if men could get pregnant, we wouldn&#8217;t see Congress trying to pass laws restricting abortion.&#8221;
Adams, who said the city would become the model for women&#8217;s health care, detailed in the plan that the clinics dispensing the controversial pill would join public hospitals citywide that already offer medication abortion.
The four sites combined could give away up to 10,000 abortion pills annually designed for women to dodge insurance issues and bills that they could otherwise face in hospitals.
The mayor&#8217;s announcement comes just 24 hours after nearly two dozen attorneys general sent a <a href="https://www.dailywire.com/news/22-attorneys-general-urge-fda-to-reverse-abortion-pill-decision" target="_blank" rel="noopener">letter</a> to Federal Drug Administration (FDA) Commissioner Dr. Robert Califf urging the agency to reverse its decision to certify retail pharmacies to dispense abortion pills.
The letter argues that the distribution of abortion-inducing drugs threatens women&#8217;s health.
&#8220;The Food and Drug Administration&#8217;s decision to abandon commonsense restrictions on remotely prescribing and administering abortion-inducing drugs is both illegal and dangerous,&#8221; the letter read. &#8220;In direct contravention of longstanding FDA practice and congressional mandate, the FDA&#8217;s rollback of important safety restrictions ignores both women&#8217;s health and straightforward federal statutes.&#8221;
Such medications used to induce abortions, Mifeprex and its generic Mifepristone Tablets, are approved by the FDA for up to 10 weeks gestation, as a woman&#8217;s health risk reportedly increases after that time.
When FDA officials first approved mifepristone in 2000, the federal agency admitted that the drug could pose &#8220;serious risks for women, including infection and bleeding,&#8221; the letter pointed out.
Officials later instituted several restrictions in 2007 as part of a Risk Evaluation Mitigation Strategy.
In November, four national medical associations and doctors filed a lawsuit against the federal government for illegally approving chemical abortion drugs that &#8220;harm&#8221; females.
The Alliance Defending Freedom, which is representing the case, accused FDA officials of &#8220;illegally&#8221; prioritizing abortion politics over science when it pushed for the legalization of the chemical abortion drugs mifepristone and misoprostol in 2000.
The organization alleges the FDA could only authorize the drugs by characterizing pregnancy as an &#8220;illness&#8221; and arguing that these drugs provide a &#8220;meaningful therapeutic benefit.&#8221;
Lawyers further allege the federal agency never studied the drug&#8217;s safety and the potential impacts it could have on blocking hormone development in adolescent female bodies.
&#8220;Pregnancy is not an illness, and chemical abortion drugs don&#8217;t provide a therapeutic benefit—they end a baby&#8217;s life and they pose serious and life-threatening complications to the mother,&#8221; Julie Marie Blake, senior counsel of the organization, said in a <a href="https://adflegal.org/press-release/doctors-health-care-groups-sue-fda-approving-dangerous-chemical-abortion-drugs" target="_blank" rel="noopener">news release</a>. &#8220;The FDA never had the authority to approve these dangerous drugs for sale. We urge the court to listen to the doctors we represent who are seeking to protect girls and women from the documented dangers of chemical abortion drugs.&#8221;
Lawyers for the Biden administration told a federal judge Tuesday that the public would be harmed if the abortion pills were made unavailable.
&#8220;The public interest would be dramatically harmed by effectively withdrawing from the marketplace a safe and effective drug that has lawfully been on the market for twenty-two years,&#8221; the filing by the U.S. Food and Drug Administration to U.S. District Judge Matthew Kacsmaryk said, Fox News <a href="https://www.foxnews.com/health/biden-fda-warns-judge-reversing-abortion-drugs-approval" target="_blank" rel="noopener">reported</a>.
Since the historic overturning of the 1973 Roe v. Wade ruling last summer by the Supreme Court, medication abortions have been sought after as an alternative abortion method.
According to the <a href="https://www.guttmacher.org/article/2022/02/medication-abortion-now-accounts-more-half-all-us-abortions" target="_blank" rel="noopener">Guttmacher Institute</a>, more than half of all “facility-based abortions” in the U.S. every year have been due to such drugs.

Woman pointing at sonogram

New York City-Run Clinics To Offer Free Abortion Pills Amid Lawsuit Against ‘Dangerous’ FDA Approved Drugs

Eric Adams

New York City

Social Issues

A group of 22 attorneys general sent a letter to Federal Drug Administration (FDA) Commissioner Dr. Robert Califf asking the agency to reverse its decision to certify retail pharmacies to dispense abortion pills.
The Friday letter, led by Alabama Attorney General Steve Marshall, argued that the distribution of abortion-inducing drugs poses a danger to women&#8217;s health.
“The Food and Drug Administration’s decision to abandon commonsense restrictions on remotely prescribing and administering abortion-inducing drugs is both illegal and dangerous,” the <a href="https://www.scribd.com/document/619779306/Letter-From-Alabama-Attorney-General-Steve-Marshall-to-FDA-about-abortion-pill-rule-change#" target="_blank" rel="noopener">letter</a> read. “In direct contravention of longstanding FDA practice and congressional mandate, the FDA’s rollback of important safety restrictions ignores both women’s health and straightforward federal statutes. We urge you to reverse your decision.”
The letter&#8217;s signers also argued that the FDA&#8217;s decision would not stop them from enforcing state laws against administering abortion pills.
“Though the FDA has abdicated its responsibility to protect women’s health, we have not. To be crystal clear, you have not negated any of our laws that forbid the remote prescription, administration, and use of abortion-inducing drugs,&#8221; the attorneys general wrote.
In addition to Alabama, the other states represented in the letter included Alaska, Arkansas, Florida, Georgia, Idaho, Indiana, Iowa, Kentucky, Louisiana, Mississippi, Missouri, Montana, Nebraska, Ohio, South Carolina, South Dakota, Tennessee, Texas, Utah, West Virginia, and Wyoming.
Last week, The Daily Wire <a href="https://www.dailywire.com/news/alabama-women-can-be-prosecuted-for-taking-abortion-pills-ag-says" target="_blank" rel="noopener">reported</a> on Marshall&#8217;s comments that women could be prosecuted for taking abortion pills in Alabama. Marshall made the remarks despite the state’s Human Life Protection Act which criminalizes abortion providers and prevents prosecution against women who have abortions.
“The Human Life Protection Act targets abortion providers, exempting women ‘upon whom an abortion is performed or attempted to be performed’ from liability under the law,” Marshall said in a <a href="https://www.al.com/news/2023/01/women-can-be-prosecuted-for-taking-abortion-pills-says-alabama-attorney-general.html" target="_blank" rel="noopener">statement</a> to AL.com. “It does not provide an across-the-board exemption from all criminal laws, including the chemical-endangerment law—which the Alabama Supreme Court has affirmed and reaffirmed protects unborn children.”
The reactions from Marshall and other state leaders came after a recent <a href="https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/information-about-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation" target="_blank" rel="noopener">update</a> by the FDA stating that major pharmacy chains would be allowed to provide two medications, mifepristone and misoprostol, prescribed for medical abortions. CVS and Walgreens, the nation’s two largest pharmacy franchises, have since noted plans to participate in the new program from the FDA.
The change from the FDA will encounter problems in at least <a href="https://www.guttmacher.org/state-policy/explore/medication-abortion" target="_blank" rel="noopener">18 states</a> that require a medical professional providing a medication abortion to be physically present when the drug is administered. The laws effectively prohibit telemedicine from prescribing medication for abortion.
The medications used to induce abortions, Mifeprex and its generic Mifepristone Tablets, are approved by the FDA for up to 10 weeks gestation, as a woman&#8217;s health risk reportedly increases after that time.
&#8220;Though there are risks to a woman of using these drugs at any point in pregnancy, abortion-inducing drugs are riskiest when used later in pregnancy. This means that accurately determining the date of pregnancy is critical for women’s safety,&#8221; Marhsall&#8217;s letter from the attorneys general stated.

Steve Marshall

22 Attorneys General Urge FDA To Reverse Abortion Pill Decision

The <a href="https://www.dailywire.com/topic/cdc" target="_blank" rel="noopener">Centers for Disease Control and Prevention</a> (CDC) announced Friday that it has launched an “additional investigation” into <a href="https://www.dailywire.com/topic/pfizer" target="_blank" rel="noopener">Pfizer</a>’s updated COVID booster after a government safety monitoring system detected a potential stroke risk for those 65 and older who received the pharmaceutical giant’s bivalent shot. 
Bivalent COVID vaccines were <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-pfizer-biontech-bivalent-covid-19-vaccines-use" target="_blank" rel="noopener">authorized</a> by the FDA last August to provide greater protection against the virus as it progressed into different strains, such as the Omicron variant. The updated boosters include a component of the original COVID strain along with a component from Omicron, <a href="https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-bivalent-vaccine-boosters#:~:text=Get%20more%20COVID%2D19%20facts,caused%20by%20the%20omicron%20variant.">according</a> to the FDA.
“CDC’s Vaccine Safety Datalink (VSD), a near real-time surveillance system, met the statistical criteria to prompt additional investigation into whether there was a safety concern for ischemic stroke in people ages 65 and older who received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent,” the CDC said in a <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/bivalent-boosters.html">statement</a>. 
The concerning VSD signal has caused the agency to question whether those 65 and older who received Pfizer’s bivalent COVID vaccine were at an increased risk of having an ischemic stroke up to three weeks after their vaccination compared to 22-44 days after the shot. The CDC said Moderna’s bivalent COVID vaccine was not identified for the same risk by its monitoring system. 
Former National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci <a href="https://twitter.com/TeamCavuto/status/1614018318587039744" target="_blank" rel="noopener">told</a> Fox News host Neil Cavuto that the detection &#8220;most likely is not going to be a relevant signal because several of the other surveillance and monitoring mechanisms that are put in place have not come up and found this signal.&#8221; Fauci added that it is good that the CDC is letting the public know about what its surveillance system has detected, but the agency is &#8220;not changing any of the recommendations of getting people vaccinated with the bivalent booster.&#8221;
The CDC added that there “may be other confounding factors contributing” to the VSD’s signaling of the Pfizer vaccine and emphasized that other studies conducted on Pfizer and Moderna bivalent vaccines did not validate the signal. Furthermore, the agency said that there has not been any increase in reports in the U.S. or other countries of ischemic strokes following the updated vaccine.
“Although the totality of the data currently suggests that it is very unlikely that the signal in VSD represents a true clinical risk, we believe it is important to share this information with the public,” the CDC said. 
The new investigation from the government agency has not resulted in any change to its vaccination recommendations, and the CDC continues to urge “everyone ages 6 months of age and older stay up-to-date with COVID-19 vaccination,” including those “eligible to receive an updated (bivalent) vaccine.”

Pfizer COVID Booster

Pfizer’s Updated COVID Booster Linked To Potential Stroke Risk, CDC Launches ‘Additional Investigation’

Pfizer's Updated COVID Booster Linked To Potential Stroke Risk, CDC Launches 'Additional Investigation'

The U.S. Food and Drug Administration (FDA) <a href="https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-disease-treatment" target="_blank" rel="noopener">granted</a> accelerated approval for a new drug designed to treat Alzheimer’s on Friday.
The drug is Leqembi, which was <a href="https://www.statnews.com/2023/01/06/fda-approves-alzheimers-drug-leqembi-eisai/" target="_blank" rel="noopener">created</a> by Japanese pharmaceutical company Eisai, which will work with Biogen in order to market and commercialize it. The accelerated approval is based on a small study that showed patients who were given the drug “had significant dose- and time-dependent reduction of amyloid beta plaque,” which is an indicator of Alzheimer’s.
When someone has Alzheimer’s <a href="https://www.nia.nih.gov/health/what-happens-brain-alzheimers-disease" target="_blank" rel="noopener">disease</a>, amounts of the beta-amyloid protein group together to <a href="https://www.alz.org/alzheimers-dementia/what-is-alzheimers/brain_tour_part_2" target="_blank" rel="noopener">create</a> plaques in between neurons, impacting how the cells work.
The drug’s price will be an annual $26,500 for someone who is of average weight. Medicare has not <a href="https://www.nytimes.com/2023/01/06/health/alzheimers-drug-leqembi-lecanemab.html" target="_blank" rel="noopener">said</a> it will cover the treatment yet.
Experts of the disease said that the drug offers modest advantages for people who have minor cognitive impairment or early Alzheimer’s disease.
The approval brings to mind Aduhelm, another Alzheimer&#8217;s treatment that was approved by the FDA in June of 2021. The drug was <a href="https://www.nytimes.com/2022/12/29/health/alzheimers-drug-aduhelm-biogen.html" target="_blank" rel="noopener">created</a> by Biogen and many Alzheimer’s scientists spoke out against it. Due to unknown upsides and potential brain swelling and bleeding risks, large health groups chose not to even provide the drug. The treatment was eventually put aside in the marketplace after Medicare restricted its coverage of it. Eisai was <a href="https://www.fiercepharma.com/marketing/biogen-revamps-eisai-alzheimers-disease-pact-taking-full-control-over-troubled-aduhelm" target="_blank" rel="noopener">working</a> with Biogen on the drug, but bowed out last year.
A congressional investigation put forward in December discovered that the FDA’s procedure for approving Aduhelm was “rife with irregularities.” The agency&#8217;s work with Biogen was questionable. The investigation also found that Biogen put a high cost on the drug.
Democratic Representative Frank Pallone of New Jersey <a href="https://www.nytimes.com/2022/12/29/health/alzheimers-drug-aduhelm-biogen.html" target="_blank" rel="noopener">said</a> in a statement that the findings “[document] the atypical F.D.A. review process and corporate greed that preceded F.D.A.’s controversial decision to grant accelerated approval to Aduhelm.”
The FDA’s own internal inquiry, done before the drug was greenlit, discovered that people at the agency didn’t listen closely enough to opposing opinions from the FDA’s statistical team, which argued that there wasn’t enough proof that the drug was successful. It also found that its work with Biogen, the maker of the drug, “exceeded the norm in some respects.”
The new drug, Leqembi, still poses some potential dangers. The FDA noted that it is incorporating a warning for Leqembi over amyloid-related imaging abnormalities (ARIA), which can lead to life-threatening and serious situations, but typically no symptoms are present.
“ARIA most commonly presents as temporary swelling in areas of the brain that usually resolves over time and may be accompanied by small spots of bleeding in or on the surface of the brain, though some people may have symptoms such as headache, confusion, dizziness, vision changes, nausea and seizure,” it noted.
It said the most frequent side effects were headache, ARIA, and “infusion-related reactions.”
 The FDA will also contemplate final approval after it receives more information from a larger study by the company in a few days, which is something it didn’t do with Adehulm, which was also approved in the accelerated format.
The larger, 18-month study of Leqembi <a href="https://endpts.com/fda-approves-alzheimers-drug-lecanemab-from-eisai/" target="_blank" rel="noopener">revealed</a> that 17.3% of patients using the treatment experienced indications of brain bleeding, while 9% of the placebo group had it. Signs of swelling of the brain also <a href="https://www.wsj.com/articles/new-alzheimers-drug-approved-by-fda-promises-to-slow-disease-11673032312" target="_blank" rel="noopener">happened</a> in 12.6% of those who took Leqembi, compared with 1.7% of those who were on the placebo. &#8220;[S]erious adverse events&#8221; <a href="https://www.nytimes.com/2023/01/06/health/alzheimers-drug-leqembi-lecanemab.html" target="_blank" rel="noopener">happened</a> in 14% of those taking Leqembi and 11% of those who got the placebo. Almost 7% of people on Leqembi ended the trial due to adverse side effects, which was more than double the percentage of people who quit who were taking the placebo.
Physicians also <a href="https://www.wsj.com/articles/new-alzheimers-drug-approved-by-fda-promises-to-slow-disease-11673032312" target="_blank" rel="noopener">reportedly</a> said that side effects can be managed with appropriate watchfulness and most patients don&#8217;t have unpleasant symptoms. If scans do find swelling or bleeding, the patient can temporarily stop receiving the drug.
But there is also concern for people who are taking blood thinners. Three people who took the medicine <a href="https://www.inquirer.com/health/fda-approves-alzheimers-drug-leqembi-safety-risks-20230106.html" target="_blank" rel="noopener">passed</a> away while on it, but Eisai said the fatalities can’t be blamed on the medicine. Two of the deceased were taking blood thinners.
The company’s clinical trial also proposed that Leqembi won’t work for around 10% of people who have two copies of APOE4, and they could be hurt by the drug. <a href="https://www.nia.nih.gov/news/study-reveals-how-apoe4-gene-may-increase-risk-dementia#:~:text=APOE4%20is%20the%20strongest%20risk,lipid%20imbalances%20in%20brain%20cells." target="_blank" rel="noopener">APOE4</a> is the most frequent genetic risk factor for the disease. Around 25% of people have one copy of it, and 2% to 3% of people have two copies.
The <a href="https://apnews.com/article/science-health-business-986f1d9a46a48a50a6b554a6c2950801">study</a> showed that people who took the drug were 31% less likely to continue to the next stage of Alzheimer’s while in the study. One kind of swelling was experienced in around 13% of people who got the drug. The treatment also put off the patients’ deterioration by around five months during the study, although the measurement of the decline was not as much as some would have preferred.
“It is unlikely that the small difference reported in this trial will be noticeable by individual patients,” Dr. Madhav Thambisetty of the National Institute on Aging, said in November. He clarified he wasn’t speaking on behalf of the agency.
Some doctors said they will prescribe the drug for patients for whom it might be beneficial, but others caution that it might not do a lot. Physicians also <a href="https://www.wsj.com/articles/new-alzheimers-drug-approved-by-fda-promises-to-slow-disease-11673032312" target="_blank" rel="noopener">note</a> that its impact isn&#8217;t strong and it isn&#8217;t the same as a cure.
“Most patients won’t notice the difference,” Dr. Matthew Schrag, a neurology researcher at Vanderbilt University, <a href="https://www.inquirer.com/health/fda-approves-alzheimers-drug-leqembi-safety-risks-20230106.html" target="_blank" rel="noopener">said</a>. “This is really quite a small effect and probably below the threshold of what we’d call clinically significant.”
Schrag said there is “less drama” for Leqembi when compared with Aduhelm, but he noted that a lot of the similar worries are still there.
“Is this slight, measurable benefit worth the hefty price tag and the side effects patients may experience?” he asked. “I have pretty serious doubts.”

8E2C2146-6532-4D72-855A-3774B9E1A288_1_201_a

FDA Grants Accelerated Approval To New Alzheimer’s Drug

FDA Grants Accelerated Approval To New Alzheimer's Drug Leqembi

alzheimer's

Medical Research

Prescription Drugs

The Food and Drug Administration (FDA) has announced that retail pharmacies like CVS and Walgreens can now provide abortion pills.
The abortion drug Mifepristone was previously only available through doctors, clinics, or some mail-order pharmacies. The new rule change from the FDA will allow any pharmacy abiding by its guidelines to fill prescription orders in stores and by mail.
&#8220;Mifeprex and its generic Mifepristone Tablets, 200 mg, are available under a single, shared system risk evaluation and mitigation strategy (REMS), known as the Mifepristone REMS Program, which sets forth the requirements that must be followed for mifepristone for medical termination of pregnancy through ten weeks gestation,&#8221; the FDA shared in a Tuesday <a href="https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/information-about-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation" target="_blank" rel="noopener">update</a>.
The FDA recommended against the purchase of Mifepristone online without a prescription.
&#8220;The FDA does not have regulatory oversight of prescription medicines from outside the legitimate U.S. drug supply chain; therefore, the FDA cannot ensure the safety, effectiveness, or quality of those medications,&#8221; the guidance noted.
<a href="https://www.guttmacher.org/article/2022/02/medication-abortion-now-accounts-more-half-all-us-abortions" target="_blank" rel="noopener">According</a> to the Guttmacher Institute, medication abortion accounted for 54% of U.S. abortions in 2020. That percentage is likely to increase as retail pharmacies provide abortion pills.
The new FDA update comes following a year of significant changes to abortion policies. In June, the Supreme Court overturned Roe v. Wade and returned abortion laws to individual states.
Thirteen states had trigger laws that further limited abortion following the court&#8217;s decision. Several additional states passed legislation after the ruling to tighten abortion restrictions.
Court battles have since ensued, with some new abortion limitations placed on hold until cases are held.
Some states, such as Mississippi, have already ruled against abortion pills. Mississippi Republican Gov. Tate Reeves said in July that doctors in his state would lose their medical licenses for prescribing abortion pills.
“If a physician is practicing medicine in the state of Mississippi, they have to have a license to do so and if abortion is illegal in our state, which it is, then those medicines will not be allowed and they will not have a license to practice in our state,” Reeves <a href="https://video.foxnews.com/v/6309044908112?intcmp=tw_fnc" target="_blank" rel="noopener">said</a> in July.
“Any physician that is practicing, whether it’s through telemedicine or otherwise… that practices in our state is practicing not only based upon the standards of care that we require in our state, but also based upon state law,” he added.
South Dakota Republican Governor Kristi Noem also signed a <a href="https://sdlegislature.gov/Session/Bill/23247" target="_blank" rel="noopener">bill</a> in March to ban telemedicine abortion.
“With this bill, we will protect both unborn babies and their mothers from this dangerous procedure,” Noem <a href="https://twitter.com/govkristinoem/status/1499140687715094531?ref_src=twsrc%5Etfw" target="_blank" rel="noopener">wrote</a>.
Eighteen states currently &#8220;require the clinician providing a medication abortion to be physically present when the medication is administered, thereby prohibiting the use of telemedicine to prescribe medication for abortion,&#8221; the Guttmacher Institute <a href="https://www.guttmacher.org/state-policy/explore/medication-abortion" target="_blank" rel="noopener">reported</a>.
Texas has a ban on medication abortion at seven weeks, while Indiana has a 10-week ban.

Abortion drug pills and drinking water – stock photo

FDA Says Abortion Pills Can Now Be Offered At Retail Pharmacies

Roe v. Wade's Long And Brutal Legacy

Menu

FDA