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Safety First...and Last

Even if industry observers are correct and the US Food and Drug Administration has changed its rules for drug approval and is now tilting toward assessing safety, not efficacy, first, the current policy falls squarely within the agency's legislative mandate. Historically, it has asked companies to conduct additional clinical trials when doubts about safety remain. But even within that requirement, the FDA has room to maneuver. And a new school of thought is leaning toward post-marketing risk management to detect serious and rare adverse effects after a drug has reached the market on the basis that its benefits outweighs its risks.

Even if industry observers are correct and the US Food and Drug Administration is now tilting in its approval process toward safety, not efficacy, the current policy falls squarely within the agency's legislative mandate. But the pendulum has swung so far that advocates are emerging for post-marketing risk management: for certain drugs whose benefits outweight the risks, companies would work to detect serious and rare adverse effects after a drug has reached the market.

A bit of history is useful here. One of the goals of the 1992 prescription drug user fee law, which implemented a $300,000 user fee in order to bolster FDA...

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