Five Things Industry Can Do to Support True FDA Reform, and Restore Public Confidence
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have created a monstrous public perception, undermined the doctor/patient relationship, and been a huge boon to personal injury lawyers. If drug companies voluntarily pulled all the ads, and were a little more forthright about the risks and benefits of medical products, I bet the public would be a lot more understanding when things go wrong, and that the FDA would take a more balanced approach to reviewing safety of new products.
3. Support legislation to ban FDA advisory committee members with conflicts of interest. The pharma industry has done a lot of unseemly things over the years, and one of them has been systematically putting money in the pockets of leading U.S. physicians in an attempt to curry favor with these “thought leaders,” so they will influence peers to prescribe certain new drugs. Many of these same thought leaders then sit in judgment of products on FDA advisory panels. The FDA has said that it needs to get advice from these experts who are on the take because it’s the only way to get expert advice. That’s bull. Pharma, and the FDA should join together in an effort to reform the advisory committee process and find independent experts. Again, that could help restore public confidence in the FDA, and by extension, the industry.
4. Full disclosure of FDA complete response letters. Right now, when the FDA turns down an application for a drug or device, its sends a letter to companies that isn’t a public record. The FDA doesn’t bother to explain most of these decisions, leaving that up to the companies to communicate. And what happens is the companies try to spin the contents of the letter, often telling the public that it’s all the fault of that unpredictable FDA. Maybe it is, maybe it isn’t. Maybe the FDA has a point that it isn’t getting as many good applications anymore. Maybe the companies themselves are just covering up some embarrassing failures of their own. Open up these complete response letters, and let the public see why the FDA made those decisions. The FDA itself has suggested this, but you don’t hear industry arguing publicly in favor of full transparency. Again, it would be a big confidence builder in the whole drug development review process.
5. Finance strong “regulatory science” programs at U.S. business schools and medical schools. It’s one thing to complain about how the FDA doesn’t have business savvy, and it’s another to do something about it. How about supporting programs at medical and business schools in emerging disciplines like regulatory science? One leading biotech industry veteran, UCSF Chancellor Susan Desmond-Hellmann, has advocated for this discipline, which seeks to help basic science ideas navigate the tough process to become products. How about putting your money where your mouth is, by supporting such programs that can help train young people who can then put those skills to work at the FDA, and inside your own companies? I’ve been hearing for years about a shortage of qualified people to work in regulatory affairs. Given the unemployment situation in the U.S., it makes a lot of sense to start training more people in this important discipline.
I’m sure our readers have a lot more ideas on how the FDA/industry interactions could improve, and what each party can do to make the drug regulation process more efficient, transparent, and accountable. I’d love to hear your thoughts in the comment section below.