Food and Drug Administration Commissioner Martin Makary says his agency is working hard to bring back &#8220;gold standard science&#8221; while Americans&#8217; trust in science and medicine is at historic lows.
&#8220;We have brought back gold standard science and taken politics out of the process,&#8221; Makary told The Daily Wire during an exclusive interview this week. &#8220;We&#8217;ve been going hard on what&#8217;s right. Be it the COVID vaccine, be it getting back to basic science — gold-standard science &#8230; We are going up against Big Food, Big Pharma, and we aren&#8217;t afraid to stand up to them.&#8221;
Makary has drawn criticism from both sides of the aisle during his 14 months as FDA Commissioner. <a href="https://democrats-energycommerce.house.gov/media/press-releases/ec-democrats-demand-answers-fdas-covid-vaccine-memo" target="_blank" rel="noopener">Democrats</a> have criticized his vaccine policies, while pro-life groups have called for his resignation over what they say is inaction on Biden-era abortion pill regulations. Asked about safety concerns surrounding the abortion drug mifepristone, Makary told The Daily Wire the FDA is committed to addressing these concerns and that a study on the drug&#8217;s safety is underway.
&#8220;There needs to be a good, detailed granular study for mifepristone, which to date has not been done. We have committed to conducting a granular study,&#8221; Makary told The Daily Wire. &#8220;We&#8217;re doing it the right way, and that study will inform any potential next steps.&#8221;
But <a href="https://www.fda.gov/about-fda/fda-organization/martin-makary" target="_blank" rel="noopener">Makary</a> has experience swimming through the turbulent waters of public opinion. A pioneering surgeon at Johns Hopkins University, Makary is the author of more than 300 peer-reviewed medical journal articles and was one of the few scientists calling out the politicization of science during the COVID pandemic.
Under Makary, the FDA is on a mission to make American children healthier, find new treatments for diseases, and regain America&#8217;s place as a world leader in scientific breakthroughs.
&#8220;When I came into office 14 months ago, the year prior, China was doing four times the number of phase one trials as the United States,&#8221; Makary said. &#8220;In the first Trump administration, the U.S. was the leader, and that changed under the Biden administration. We walked into a mess.&#8221;
Makary says the agency is achieving its mission in record time. Within weeks of his March 2025 Senate confirmation, the FDA and the Department of Health and Human Services announced an initiative to phase out petroleum-based food dyes, something Makary says the FDA talked about doing for decades.
&#8220;We announced action to remove all nine artificial dyes from the U.S. food supply,&#8221; Makary told The Daily Wire. &#8220;A lot of companies are ahead of schedule. It is a tremendous success. These are petroleum-based artificial dyes. American kids don&#8217;t need more petroleum in their bodies.&#8221;
In the past 14 months, the FDA has also taken steps to <a href="https://www.hhs.gov/press-room/wtas-fda-announces-major-steps-implement-real-time-clinical-trials.html" target="_blank" rel="noopener">modernize</a> and increase the efficiency of drug applications and trials. The FDA launched the Commissioner&#8217;s National Priority Voucher program, which <a href="https://www.youtube.com/watch?v=CzMG6_hOB5w" target="_blank" rel="noopener">reduces wait times</a> for drug applications and allows therapies for rare diseases to forgo randomized trials, which are <a href="https://www.hhs.gov/press-room/wtas-fda-launches-framework-accelerating-therapies-ultra-rare-diseases.html" target="_blank" rel="noopener">difficult</a> to conduct due to small patient populations.
&#8220;We introduced a new pathway to approve drugs at the speed patients would demand if they&#8217;re suffering from a terminal or debilitating condition,&#8221; Makary said. &#8220;Typically, the FDA takes a year to review and file a drug application. We have that down now to one to two months, regularly.&#8221;
The Daily Wire asked Makary about criticisms he&#8217;s faced over the FDA&#8217;s rejection of several drug applications, including those for cancer treatments. Patient groups say Makary&#8217;s FDA is <a href="https://www.wsj.com/opinion/president-trumps-marty-makary-problem-08ebd71a">slow-walking</a> rare disease drugs, making companies jump through unnecessary hoops in order to get approval for things like Huntington&#8217;s Disease.
But Makary says it&#8217;s simply a matter of good science.
&#8220;There&#8217;s a very simple system at the FDA: if the drug works, it gets approved,&#8221; Makary told The Daily Wire.
In an effort to regain the public trust in science and medicine, the FDA is giving the public unprecedented transparency of the drug application process.
&#8220;If the drug fails in its trial and the FDA does not approve it, in my opinion, the public deserves to know why. So we have taken the bold step of making our decision letters public information.&#8221;
The FDA has posted the complete response letters of approved and non-approved new drug applications on its<a href="https://open.fda.gov/apis/transparency/completeresponseletters/" target="_blank" rel="noopener"> website</a>.
&#8220;In the past, politics has resulted in overruling scientists at the agency. But in this Trump administration, we stand by our scientists,&#8221; Makary told The Daily Wire.
&#8220;Every time the commissioner has overruled scientists at the FDA, it&#8217;s been a fiasco. The Biden administration overruled scientists who recommended against approving the Covid vaccine for healthy children. It was a fiasco.&#8221;
The FDA is also taking bold steps to improve the quality of school lunches and baby formula.
After hearing from parents wanting better quality food in schools, the FDA launched a <a href="https://x.com/DrMakaryFDA/status/2045249715642495124?s=20" target="_blank" rel="noopener">pilot</a> program giving schools resources to provide healthier meals to students. The program has been hugely successful, showing a 70 to 80% reduction in pesticides and 80% to 90% reduction in heavy metals contained in school lunches, Makary told The Daily Wire.
&#8220;We proved that you can make a switch to healthier food in an affordable way,&#8221; Makary said.
On April 29, the FDA released results of the <a href="https://www.fda.gov/news-events/press-announcements/fda-releases-results-largest-ever-testing-infant-formula-us" target="_blank" rel="noopener">largest-ever testing</a> of infant formula in the United States, testing more than 300 infant formula samples for contaminants such as mercury, lead, and forever chemicals like PFAS. The testing found the samples overwhelmingly had undetectable or very low levels of contaminants, which Makary called a &#8220;resounding success.&#8221;
&#8220;Many companies find it too hard to bring new products to market because you have to follow a rigid recipe,&#8221; Makary said. &#8220;So we are modernizing the monograph that&#8217;ll enable more companies to come to market, that will both lower prices and create more options for moms that are healthier, while at the same time, make the supply chain more resilient.&#8221;
In the midst of swirling public opinion, Makary remains focused on the FDA&#8217;s mission to promote strong science and healthier Americans.
&#8220;We set the priority of the agency to a simple mission of more cures, meaningful treatments, and healthier food for children.&#8221;

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EXCLUSIVE: FDA Commissioner Marty Makary Says He’s Taking Politics Out Of Science

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EXCLUSIVE: FDA Commissioner Marty Makary Says He’s Taking Politics Out Of Science