An Open Letter to FDA’s New Commissioner

By: Cynthia Pearson

Dear Commissioner,

I wish you well. Honestly, I do. You’ve got a big job with, well, challenging bosses. But you know what? We’re your bosses, too. The public pays for more than half of the Food and Drug Administration’s (FDA) budget each year, which entitles us to have a say in the agency’s  operations. Late last year, we gave your predecessor, Scott Gottlieb, a report card on his first year as Commissioner—he got mixed grades. Here’s what you could do to get all A’s on your report card:

  1. Don’t let the White House push you around. Commissioner David Kessler threatened to resign when the administration tried to kill the FDA’s plan for nutrition labels. He won. Stand up for what’s right. 
  2. Don’t let politics override science on reproductive health. Abortion care is health care and medication abortion is a medical product, not a political football. Immediately withdraw the FDA’s politically motivated and medically unnecessary mifepristone restrictions.
  3. Require companies to include women, older adults, and people of color in clinical trials in numbers proportionate to their experience of the conditions being studied. Trials of heart attack drugs have only 60% as many women as they should. Don’t let staff continue using the excuse that women think heart disease is a male disease.  
  4. Stop accepting industry’s excuses for failing to do post-market studies they promised to do, and start imposing consequences. Since 2013, two breast implant manufacturers have repeatedly failed to follow up with patients in studies about long-term health effects; yet, FDA staff says merely: “The FDA may take action.” Impose some penalties, already!
  5. Stop approving drugs for long-term use in healthy people based just on lab tests. The FDA approves drugs to prevent osteoporosis based on X-ray results, not whether the drug prevents clinical fractures that cause symptoms. Require companies to show that drugs for healthy people actually improve health.
  6. Don’t fall for fake consumer groups. “Even the Score” pretended to be a grassroots advocacy effort committed to improving women’s sex lives. In reality, a drug company created the group after being unable to get its product approved through normal channels.  Even the Score folded shortly after the company’s drug gained approval.  
  7. Don’t weaken FDA’s standards for approving new products. Last summer, the FDA used an expedited process to approve a smartphone app that’s a 21st-century version of the rhythm method. Your staff accepted the company’s word that the Natural Cycles app is as effective as the birth control pill. Guess what happened? Unintended pregnancies, that’s what.  
  8. Value the Offices of Women’s Health and Minority Health.  Keep the offices’ directors in your inner circle and listen to their advice.  

Acting on these recommendations requires you to prioritize science and public health over special interests, including drug and device manufacturers. This may be challenging for someone nominated by the Trump-Pence administration, but we, your employers, hope you’ll do the right thing. Good luck!