FDA Under Attack: Can Industry Help?

In the recent days, FDA has come under constant attack for being “slow and burdensome” by none other than its own boss. The anecdotes have the risk of becoming mainstream when at the first address to the joint session of the Congress; the President uses a false case to demonstrate how the FDA process is delaying life-saving drugs from getting to the patients. But FDA cannot do anything about it. It cannot openly defend itself from the statements of the politicians who govern it. However, a weak FDA is bad for the industry too. Over the last 3 decades, regulations in the US have come a long way. The first major FDA-Industry collaboration was the passage of the Prescription Drug User Fee Act (PDUFA) in 1992. In the last 25 years, numerous programs were launched to expedite drug approvals, encourage innovation, incentives beyond approving product, and multiple ways to meet and negotiate with the reviewers. FDA currently approves products faster than its closest counterparts in Europe, the EMA, and practically helps most of the regulators in the World understand and create high-quality regulatory programs. And FDA has come to rescue of companies numerous times by approving products faster, providing valuable feedback to move development along, risk reduction, liability reduction and assuring insurance coverage for approved products. Even the product used by the President at this address was approved in nine months based on one clinical trial in 39 patients. It was a poster case of how FDA can approve products faster in case of life-threatening conditions. The fact that the patient still chose to sit at the address to make a false points hurts everyone. There is no argument that there are portions of FDA that can be improved but to accuse the entire process to be burdensome is unfair. And some leaders in the industry have stepped in to defend the FDA. A few articles by experts have tried knocking downing the argument against a systematic reduction of FDA’s mandate. But it may not be enough against a tide of negative public opinion created using anecdotes and false examples. It’s time for the industry to defend FDA to the politicians and public. Not that it needs it. FDA implements laws passed by the Congress and those laws are not going anywhere. Most likely except for a few cosmetic changes, FDA will stay the same and its personnel will keep doing their job. But will be good for the morale of the reviewers? The laws of the country make sure that FDA personnel have absolutely no conflict with the products they review; approving or rejecting a product does not affect the tenure of an FDA reviewer. While the public and politicians seems to assume otherwise, the industry knows better. And we should do it, not because we have to, but because it is the right thing to do