FDA Says Hurray for More Drug Safety

FDA Says Hurray for More Drug Safety [Fool.com] January 31, 2007
By Brian Lawler

January 31, 2007

The safety of pharmaceutical drugs has been a favorite topic in the media and at the FDA for the past several years, ever since Merck (NYSE: MRK) pulled its COX-2 inhibitor, Vioxx, from the market in 2004. Then Biogen IDEC (Nasdaq: BIIB) and partner Elan (NYSE: ELN) had to temporarily pull their multiple sclerosis treatment, Tysabri, from the market in 2005 over safety concerns. Investors in the pharmaceutical industry have to be particularly attentive to how the winds of regulation blow at the FDA, since drugs need to gain approval from the agency before they can be marketed in the United States.

The two most important qualities of a pharmaceutical product are efficaciousness and safety, and while Vioxx posed a danger to some who took it, eventually an FDA advisory panel voted to allow it back onto the market. Nonetheless, Vioxx has captured media attention and been portrayed as a big mess-up by Merck. One of the biggest impacts from the Vioxx travails was a call for more oversight and improvement of the "safety" of drugs on the market and those awaiting regulatory approval.

To this end, the FDA released a comprehensive report yesterday outlining how it plans to improve in its goal to promote the health of the public and do things like prevent so-called "dangerous drugs" like thalidomide from being used for purposes they weren't intended for.

Most of the suggestions for improving drug safety involve the tightening up of the FDA's regulatory review process and are rather broad in scope. For instance, the FDA proposes to use more scientific approaches to evaluating drugs for marketing, and other broad measures like "improving communications" between everyone involved in promoting the safe use of medical products.

The most obvious effects that occur when the agency places a greater emphasis on safety is that the hurdle drug companies must overcome in getting their compounds to market is raised. It's logical from a self-preservation perspective for those at the agency to want to take steps to try to improve the safety of drugs, considering the media outcry that occurred over Vioxx.

Drug safety is sort of an oxymoron, as drugs are inherently unsafe and can have all sorts of side effects on the body. The FDA is always involved in a delicate balancing act between consumer safety and consumer choice. The reality of the situation is that many patients don't make informed decisions about their health when it comes to drug choice. In other situations, such as acute care, they are often incapable of making decisions regarding their care. Whatever the FDA does, though, pharmaceutical investors should hope that its renewed interest in drug safety doesn't make the already lengthy process of bringing drugs to market any longer.

Biogen Idec is a Stock Advisor recommendation. Merck is a former Income Investor pick.

Fool contributor Brian Lawler does not own shares of any company mentioned in this article. The Fool has a disclosure policy.

http://www.fool.com/investing/general/2007/01/31/fda-says-hurray-for-more-drug-safety.aspx

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