Tuesday, May 02, 2006

How the US Drug Safety System Should Be Changed

The Journal of the American Medical Association has published a commentary article about proposed changes to the FDA.  The author is Brian L. Strom, MD, MPH, a professor at the University of Pennsylvania School of Medicine.  The article itself is subscription-only, but Penn's website has an article about the article:
Commentary on How the US Drug Safety System Should Be Changed
MAY 2, 2006

In the May 3 issue of the Journal of the American Medical Association, Brian L. Strom, MD, MPH, Professor of Public Health and Preventive Medicine and Chair of the Department of Biostatistics and Epidemiology at the University of Pennsylvania School of Medicine, analyzes the limitations of the current system of drug-safety monitoring and proposes a solution that addresses overly aggressive early marketing practices; an absence of incentives to complete post-marketing safety studies; direct-to-consumer (DTC) advertising that can promote non-critical use of "blockbuster" drugs; the current trend toward delaying drug approval; and public misunderstanding about the safety of drugs. [...]

Strom proposes an alternative approach with three elements: conditional approval, an empowered US Food and Drug Administration (FDA), and a complementary nongovernmental organization.  [...]
Dr. Strom explains that any new drug should have a two-step approval.  When it is first released on the market, it would be sold under a conditional approval.  This would be like a probationary period.  During this period, the drug would carry extra warnings, and direct-to-consumer (DTC) advertising would be limited.  In order to get rid of the extra warnings, the pharmaceutical company would have to comply with required post-marketing safety studies.  

His other two recommendations are good ideas, but they have been promoted before by others, and I won't discuss them now.  It is the first recommendation that caught my interest.  

It would seem that pharmaceutical companies would resist the notice of a two-tiered approval, at least at first.  After investing all that money on a new drug, they want to recoup their investment as quickly as possible.  Advocates of small government might oppose the idea, because it would generate a new level of regulation and an awful lot of paperwork, and a small army of government employees to handle all that paperwork.

However, the fact is, pharmaceutical companies have not been doing as much post-marketing safety testing as they are supposed to do.  The FDA does not really have any way of compelling them to do so.  By using a two-tiered approval process, they would have some incentive to offer.  

Another possible benefit to the two-tiered process, could be a reduction in liability exposure for the company.  

Regarding the potential objection over increasing the size of government, it would seem that there are times when a bigger government is called for.  The issues regarding drug safety are getting more complex, as exotic new medications are developed.  At the second stage of approval, it should be possible to get input from a wider variety of professionals, who actually have experience prescribing and studying the drug.  It would allow for a more detailed assessment of the product.  During the first stage of approval, it may be difficult for the agency to know what questions they should be asking.  After the drug has been on the market for a while, there would be more specific hypotheses to be tested.  

Overhaul of the FDA is overdue.  Getting it to actually happen in today's political climate will not be easy.