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The federal Food and Drug Administration regulates food, drugs, medical devices, vaccines, cosmetics and tobacco to protect the public from products that could cause harm. FDA approval means that agency has determined that the benefits of the product outweigh the known risks.
Currently about 55 percent of the funding for the FDA is provided by the federal budget and the remaining 45 percent is paid for by industry user fees. These fees are paid upfront for the evaluation of a particular product that requires FDA approval.
Once approval is obtained, the medication or device can be prescribed or sold to the public.
Once a pharmaceutical company gains federal approval sell a new medicine, it can make a lot of money.
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.
FDA approval is often cited as a reason why a particular medication or treatment is covered by insurance. For the duration of the medication’s patent, this often means significant profits for the company that developed it — and its shareholders.
The FDA does not share in any of these dollars. But what if the agency did receive a small percentage of the profits from approved medications or devices? It could increase its staffing and approve new medications at a quicker rate.
Supplements, a billion-dollar industry that is currently unregulated, could be required to have a certification of the actual ingredients in the bottle.
Additionally, the FDA could use the fund for enriching its post-market surveillance program of newly approved products. Rather than waiting for clinicians, companies or patients to report adverse outcomes, studies could be done to monitor the safety and efficacy of the products.
If a product requires a recall, this might happen sooner with less harm done.
The additional money could also be used to revise the fast track for medical devices known as the 510 K process.
This process allows a device that is considered substantially equivalent to a current legally marketed approved device to get approved quickly. But unless it’s a superior product, this process can allow several similar products to be made that almost certainly cost more than the original. Studies to prove a product is better than a prior version very costly, but needed if medicine is going to advance.
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.
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.
This partnership could further the collaboration of the FDA and the industry players by aligning the incentives for both parties to see the discoveries succeed, as everyone would share in the profits.
Why shouldn’t the very agency whose approval is required for a medicine or device to be sold share in the success of that product, using the proceeds to better protect the public?
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Kathleen Kozak, M.D., is an internal medicine physician at Straub Clinic and Hospital. She is also a part-time medical director for UHA Health Insurance and is the host of “The Body Show” on Hawaii Public Radio.