Thursday, September 19, 2019

Thursday, September 19, 2019

Should FDA be allowed to share in the profits during its approval process?


A Hawaii doctor opined in a column if the Food and Drug Administration should share in pharmaceutical and medical research profit.

Kathleen Kozak, an internal medicine physician at Straub Clinic and Hospital, pointed out in the Honolulu Civil Beat, that about 55 percent of FDA funding comes from the federal government and the remaining is paid for by industry fee users.

Kozak writes, “the length of time it takes for a new drug to make it to market is often a point of contention, with funding shortages often cited as a reason for delays. After all, the FDA does not collect any money or fees based on the success of the products that its does approve. Maybe it should.”

Richard Williams, a senior affiliated scholar at Mercatus at George Mason University in Fairfax, Va., weighed in.

“In general, this seems to respond to the fact that drug approvals take too long, are too expensive, and rely too much on premarket approval, particularly efficacy. What's more, currently most drugs are ‘population-based’ which means that they will work for some but not for others. With current clinical trials, that information is lost in statistical significance,” Williams told the FDA Reporter.

All in all, Williams doesn’t think sharing the profits is the answer.

“The answer is to revamp the laws so that FDA is not responsible for effectiveness up front, but only for safety. They can then take the additional resources and apply them to post-market surveillance.

“I think as a matter of visible public policy, this would be a disaster as anything that went wrong would be pinned on FDA not just for not doing their job, but trying to bolster their budget. It also might mean that the recent emphasis on orphan drugs might be reversed if they are seen not be big money-makers.”

Kozak asks the question what if the FDA got a small percentage of profits from medications or devices. That way, she points out the FDA could approve medicines at a quicker rate and increase its staffing.

If the FDA could get a percentage of the pie, Kozak said more products could be reviewed.

“Supplements, a billion-dollar industry that is currently unregulated, could be required to have a certification of the actual ingredients in the bottle. There could even be safety testing and even efficacy studies to prevent unnecessary spending on pills that don’t work,” Kozak wrote.

“With the current record profits of the pharmaceutical industry, this additional payment to the FDA could advance the current efforts of the agency and also allow for expansion into previously unregulated areas in an effort to protect the public.”

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US Food and Drug Administration

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FDA Reporter