Sunday, August 29, 2010

FDA Warning Letters: The 30,000 Foot View

In 2008, the FDA issued 21 warning letters for what it considered misleading marketing tactics. So far this year, the agency has issued 68 – Baxter International Inc. received one in early September. A week after the FDA said that the drug maker made misleading claims about the efficacy of its lung drug, Aralast, Baxter withdrew the offending material.

We think it’s time to take the 30,000 foot view on the FDA’s aggressive game plan.

Are industry members behaving so badly that the agency has had no choice but to triple the number of warnings? We think that’s unlikely. What is more likely is that the FDA is reacting to political pressure to rein in industry members. While in some cases there is arguably a need for such pressure, we have to ask: Are patients getting good information from all this regulation, and is it even valuable?

From our vantage point, the FDA's promotional review processes are over-regulating marketing materials, and all these warning letters show that. One unintended consequence of the agency’s overzealousness -- as well as some industry attorneys' -- is that the public thinks that industry products are unsafe. Now our interpretation of the FDA's guidance is to warn and make people aware of the risks, but should the risks outweigh the benefits a new therapy can have?

Could all this "regulated information" being put out by companies be creating more harm than benefit?  More patients are looking for product information on the Internet. What happens when they end up on sites where the information is less than accurate?

While we suggest that industry members follow FDA regs to the letter so they can avoid embarrassing mentions in the media, we also would love to see the agency explain how its mandates are contributing to the public’s health. Is the end product of a FDA promotional review really well received by the public?

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