An Early Gift to Drugmakers

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The FDA typically approves drugs for use in fighting particular diseases. In addition, doctors are generally allowed to prescribe those drugs to treat diseases other than those specified by the FDA, but drug companies aren't allowed to market their drugs to doctors for these so-called off-label indications. That could all change, however, if the FDA's newly proposed rules go into effect.

The new rules would allow drug companies to distribute copies of peer-reviewed journal articles about clinical trials. The drugs would still have to be FDA-approved, but the trials could be about patient populations other than what the drug is approved for.

The new rules could help drugmakers such as Onyx Pharmaceuticals (Nasdaq: ONXX) or ImClone Systems (Nasdaq: IMCL), companies that get good clinical trial data but have to wait six months to a year (or more) for an FDA approval to market their drugs to doctors. Currently, their only choice is to present the data at scientific meetings or in peer-reviewed journals and hope that doctors are paying attention. Sometimes that works, but drugmakers would certainly love to be able to hand the doctor a copy of the article, rather than hope the doctor opens up a journal.

The draft regulations are far from a sure thing. Congressman Henry Waxman, a frequent critic of the drug industry, appears staunchly opposed to the changes. In a letter to the FDA commissioner, he cites numerous examples of drugs, including Merck's (NYSE: MRK) Vioxx and Pfizer's (NYSE: PFE) CELEBREX, that had data published in peer-reviewed journals that was later proven inaccurate.

While I agree that the peer-reviewed system isn't perfect, I'm not sure that doctors are going to put more faith in the journal article if it's handed to them from a sales rep than if they read it in the journal itself. Sure, more doctors will see the articles that are wrong if the rules go into effect, but a lot more will also see articles that are right. The latter could save lives -- and make drugmakers some extra cash as well.

More Foolish ramblings about the FDA:

• Welcome to the New Era of FDA Regulation
• Is the FDA Still Approving New Drugs?
• Scrutinizing FDA Drug Approvals
• Fewer Drug Approvals? Buy!