A Statement from FDA Commissioner Marty Makary, M.D., M.P.H: 100 Days of Embracing Gold-Standard Science, Transparency and Common Sense

As I mark my hundredth day on the job at the FDA, I’m proud to celebrate the agency’s accomplishments in the bipartisan effort to Make America Healthy Again. I came here with big questions: Why does it take ten years for a drug to reach patients? How can we fix America’s  food supply so it is not filled with harmful chemicals and additives? Why are childhood chronic diseases so prevalent? We are taking bold action to address these big, obvious problems, and more, which have been staring at us for years.

The FDA regulates products that account for 20% of all U.S. consumer spending, and our work impacts the lives of every American. Over the past 100 days, we’ve launched dozens of key initiatives across the full range of the FDA’s purview to help make food healthier for children and families, accelerate meaningful cures and treatments, and modernize the agency with transparency, gold-standard science and common sense. Highlights include:  

Food – Healthier Food for Children

• Fixing America’s Food Supply
  • Petroleum-based food dye removal – Took action to phase out petroleum-based synthetic food dyes from the U.S. food supply, which are linked to numerous health risks.
  • Improving infant formula – Continued the work of Operation Stork Speed by hosting an expert roundtable on infant formula and exploring new ways to bring additional and healthier options without ingredients like seed oils, added sugars and heavy metals to market.
  • Food chemical review – Initiated a robust, transparent review of chemicals currently in the food supply, such as BHT, BHA and ADA; and expedited the review of chemicals currently under review, such as phthalates, propylparaben and titanium dioxide.
  • GRAS reform – Exploring rulemaking to require “generally recognized as safe” (GRAS) submissions to FDA to stop industry’s long-standing practice of introducing ingredients into the food supply without FDA knowledge or oversight.
  • Natural food dyes – Approved uses of three food colors derived from natural sources: Galdieria extract blue, butterfly pea flower extract and calcium phosphate, and initiated an accelerated the review of other natural alternatives.
  • Began revising broken dietary guidelines – Launched the Nutrition Regulatory Science Program in partnership with NIH to better address highly relevant questions for Americans’ health, such as the impact of ultra-processed foods and the effect of certain food additives.
  • Defining ultra-processed foods – Will launch FDA/USDA request for data and information to help develop a uniform definition of ultra-processed foods, and industry roundtable, paving the way for additional study and action.

More Meaningful Cures, Treatments and Diagnostics

• Accelerating Cures  
  • Reducing animal testing – Published a roadmap to transition away from animal testing for investigational new drug applications wherever possible and use more effective, human-relevant methods, such as organ-on-a-chip systems, advanced computer simulations, and pre-existing international data. Announced the intent to launch a pilot program in which select monoclonal antibody developers may pursue a primarily non-animal-based testing strategy, under close FDA consultation.
  • Commissioner’s National Priority Voucher program – Announced a pilot program to expedite drug review processes from 10-12 months to 1-2 months following submission of a final application addressing U.S. national priorities, such as tackling a major health crisis or unmet public health need, increasing domestic drug manufacturing, and delivering more innovative cures for the American people.
  • Revised Covid-19 vaccine regulatory framework – Adopted a new evidence-based approach to Covid-19 booster approvals, replacing a one-size-fits-all regulatory framework and broad marketing authorizations with a risk-stratified approach that is already embraced by most doctors and parents. Updated labeling of mRNA shots to include new safety information about myocarditis and pericarditis.
  • Addressed industry influence – Limited the circumstances where individuals employed at FDA-regulated companies, such as pharmaceutical companies, may serve as members of FDA advisory committees, where statutorily possible, to mitigate perceived conflicts of interest and strengthen integrity to the review process.
  • CEO Listening Tour – Launched a six-city listening tour to meet directly with pharmaceutical and biotech executives, gathering honest feedback and big ideas to help the agency better accelerate cures and innovation.
  • Cell and Gene therapy innovation – Engaged dozens of industry experts in a roundtable to shape actions that will ensure America leads at the forefront of innovation in this space.
  • Removed restrictions on certain gene therapies – Removed REMS requirement for currently approved BCMA- and CD19-directed autologous chimeric antigen receptor CAR T cell immunotherapies, the first of many steps towards a more common-sense regulatory approach in this space.
  • Diagnostics to empower healthy decisions – Cleared the first in vitro diagnostic device that tests blood to aid in diagnosing Alzheimer’s disease.  Initiated process to remove regulations on Laboratory Developed Tests (LDTs).
  • Extended-release drug labeling change – Revised labeling on extended-release stimulants for ADHD treatment, cautioning parents and providers about the risks of adverse reactions, including weight loss, when used by children under six.

Administration – Gold-Standard Science & Common Sense

• Protecting American Consumers
  • Combatting illegal vapes – In collaboration with U.S. Customs and Border Protection, seized nearly $34 million worth of illegal, youth-appealing e-cigarette products originating in China.
  • Protecting the microbiome from fluoride tablets – Initiated action to remove concentrated ingestible fluoride prescription drug products for children from the market, which were not FDA-approved and have been shown to alter the gut microbiome.
  • Examining talc – Hosted an expert panel to review the latest evidence and discuss potential health risks associated with talc used in food, drugs and cosmetics.
  • Unannounced foreign inspections – Expanded the use of unannounced foreign inspections where appropriate, holding domestic and international drug manufacturers to the same high standard.
  • Holistic inspection policy review – Began comprehensive review of the agency’s policies and practices for foreign inspections (including policies related to travel accommodations), ensuring the FDA remains the gold standard for regulatory oversight.
  • Protecting American’s biological samples – Initiated action to review and, where necessary, halt clinical trials which involve exporting Americans’ living cells and DNA to labs in hostile countries, such as China, for genetic engineering and subsequent infusion back into U.S. patients.
  • Enhancing drug importation – Fought high prescription drug prices by working to streamline the process by which states can pursue importation of safe, effective and affordable drugs from Canada, without imposing additional risk to public health and safety.
  • Cracking down on falsified data – Discovered that third-party testing companies in China were producing falsified or otherwise invalid data; acted swiftly to protect the integrity of the premarket application process and the medical device supply chain.
  • Fighting “gas station heroin” –Issued warning letters against companies distributing and selling unlawful tianeptine products, warned health care professionals and the general public about the extensive adverse events associated with tianeptine use.
  • FDA import alerts – Updated several import alerts – for certain dietary supplements, cheeses, seafood, fish products and more – to help prevent illegal and unauthorized products flooding the U.S. market and risking American’s safety and health.
• Unleashing AI and Big Data
  • AI-assisted review – Completed a successful first AI-assisted scientific review pilot, demonstrating that internal AI tools can greatly reduce the time reviewers spend on mundane tasks or non-productive busywork.
  • Equipping reviewers with internal AI tools – Launched Elsa, a generative AI tool designed to help all FDA employees – from scientific reviewers to investigators – work more efficiently. Elsa is just an initial step in the FDA’s larger plans to integrate AI into agency processes.
  • Building a better adverse event reporting database – Launched a comprehensive effort to consolidate disparate adverse event reporting databases, which will enable far more effective post-market monitoring of drug products.
• Modernization and Radical Transparency
  • Transparent communications – Created FDA Direct, a regular channel for communicating directly with the public through frequent, unscripted conversations with the FDA Commissioner about strategic updates and the thinking behind key agency decisions.
  • Transparent agenda – In the Journal of the American Medical Association, provided a clear outline of FDA leadership’s priorities for modernizing and improving the agency in the months ahead.
  • Transparent decision making – Began publishing, to the greatest extent possible, decision letters issued in response to applications for new drugs and biological products.

I’m excited by what the talented FDA team have been able to achieve in 100 days by embracing gold-standard science, radical transparency and common sense. This is just the beginning. We’ll continue to introduce initiatives to modernize the agency, protect consumers, bring more meaningful cures, treatments and diagnostics to patients, and make healthier food available for children, using the best science and data to Make America Healthy Again.

Related Information

###

---