More suggestions for FDA reform for a Trump presidency

Jessica Adams was a reporter who chosely followed the FDA, here are her suggestions for reform at the US Food and Drug Administration.

I agree with nearly all of them, though I would make slight modifications

-Vinay Prasad

1. Ban pharma direct to consumer ads and put an end to FDA promotion of drugs they regulate.

2. Restore advisory committees and reform them. Consider some of these recommendations that were made at the public listening listening session in June.

3. Improve transparency in how decisions are made

4. -enforce postmarket study commitments for timely conduct and public reporting of results.

5. Defend robust approval standards, apply them consistently with parity.

6. Get FDA out of the "misinformation-policing business.

7. Stop overreach into the practice of medicine.

Here's what I hope you'll give reconsideration to:

8. A total ban on the “revolving door.” Government agencies benefit from having staff with industry experience and vice-versa. A total ban wouldn’t be feasible or helpful. However, adding limitations, oversight and accountability is in order.

9. Banning user fees. I see this as a fees for review that are being done without bias. Barriers to entry due to high fees should be looked at. I think a small business waiver is already in place, but is it adequate? In addition, look into if the structure for how FDA can allocate user fees is too rigid. The FDA should be permitted to apply user fees flexibly to meet the Agency’s needs, and accordingly they should put more toward funding postmarket follow-up.