FDA can ensure adequate drug supply [Letter]

January 08, 2014

Del. Dan Morhaim's recent commentary regarding the drug shortage ("Medication crisis," Jan. 5) was interesting and I'm glad this issue is getting more discussion in the lay press. It's been a thorny problem for the institutional pharmacy profession for decades. I'm a 40-year pharmacy practitioner who wonders why Congress can't empower the U.S. Food and Drug Administration for a much more active role in addressing the problem.

It is often the case that large proprietary pharmaceutical manufacturers abandon active marketing of their products when those products have reached the end of their patent protection and their market is challenged by a less expensive generic product.

I understand the general financial forces at work. There is some carry-over of brand name prescribing, but the substantially decreased price of the generic product from the branded innovator product usually means the original will be unprofitable and the brand name product is discontinued. Regardless of the definition of "unprofitable," the market has accommodated to the available sources, and when one source is discontinued, there is a buyers' shift to remaining generic sources.

Generic pharmaceutical manufacturers typically run on much smaller profit margins than brand name companies. Their manufacturing runs and quantities are closely tied to expected sales. When another source for a competing product disappears, the generic supplies can be exhausted quickly. This can be a good thing in the short run for the generic company but bad in the long run for the market and for patients. Even in a market with multiple sources for generically equivalent products, there can be a domino effect as supplier after supplier is overwhelmed by shifting demand. Unfortunately, this scenario is all too common with established drugs that have become therapy mainstays.

Here's my suggestion. It's not simple, and I expect there would be a firestorm of industry criticism. A new legal specialty would be created to discover loopholes and circumventions. I'm not smart enough to figure out all the details. The FDA should be empowered to require large innovator drug manufacturers to "adopt" certain mission-critical generic drugs and insure that they not be allowed to run short. We don't particularly care what it takes for you to do that (legally) but the adopted drugs must always be in adequate, reasonably-priced supply. In return, the FDA will allow said large innovator drug manufacturer to sell its blockbuster mega-profit drugs in the lucrative U.S. market. Quid pro quo.

There might be all sorts of wrinkles — for example, dollar sales caps for failing to support the generic adopted drug — but the thrust is straightforward. If you want access to the most profitable national sales market on the planet, you must be invested in the overall health of that market and its target consumers — the patients.

Richard Closson, Santa Barbara, Calif.

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