Never has Washington witnessed such a colorful and unpredictable presidential transition. The FDA has been mentioned a few times by the new President but is not a major target. Drug prices are.
Recognizing that this administration is unpredictable, here are some predictions about the FDA under President Trump:
1. Despite talk about deficiencies in the drug approval process, it will remain largely unchanged. All stakeholders – industry, patient groups, and professional organizations – agree that the FDA sets reasonable standards and expedites breakthrough drugs. No influential constituency wants lower clinical or quality/manufacturing standards. And the FDA bureaucracy will push back at efforts to lower the efficacy standard.
2. This year will see more new drug approvals than 2016 did. President Trump is fond of superlatives. He will want his FDA to exceed the 22 of novel drugs approved during President Obama’s last year.
3. There will be more flexibility in how manufacturers communicate information not included in approved labeling. In January, Obama’s team issued draft guidance’s on communicating with payers and on what constitutes “consistency” with labeling. The industry will continue to press for more flexibility and clarity. Trump’s FDA is likely to be receptive.
4. A final guidance on communicating with payers will be issued. I expect that companies will be given safe harbors on communicating healthcare economic information and on providing product information to payers pre-approval.
5. There will be more enforcement actions with regard to distractions during the presentation of risk information in DTC TV ads. In December two enforcement letters cited this concern. The FDA will continue to look for instances where visual or other distractions undermine the communication of risk information.
6. The Prescription Drug User Fee Act and other user fees will sail through Congress without requiring major changes by FDA in the approval process, or without adding to the FDA’s responsibilities.
In short, the Trump team, I predict, will seek to tweak FDA. But there will be no effort to overhaul it, either administratively or legislatively. The FDA is functioning well, and once new leadership comes in, they will see that fundamental change is not needed, and it will not be accepted by stakeholders, including the industry and patient community.
Wayne Pines is president of healthcare at APCO Worldwide.