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A Gun-Shy FDA?

Executive Summary

FDA drug review times are up, and the number of approvals are down, with a wary investment community taking note and adding a new element to their earnings projections. The lack of a permanent FDA commissioner, understaffing, and the recent recalls/withdrawals of approved drugs are among the factors that may be leading to a slowdown. But whatever the significance of any shift in approval patterns over the last year or two, there are longer-term regulatory causes of concern for the drug industry--some attributable to the agency, but others stemming from the industry itself. With novel drugs taking up an increasing proportion of drug company pipelines, the FDA's staffing problems are compounded by having to evaluate therapies for which there are no reference points. The agency, having learned the hard way that it's extremely difficult to manage risk once a drug hits the market, will be particularly careful before passing on groundbreaking medications. And that tendency towards caution is only likely to become stronger as consumers become a powerful force in affecting prescribing patterns.

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The FDA and Antibiotics: An Unsettled Agency of Many Minds

About two years ago, the FDA began tightening the statistical standard that companies must meet to demonstrate the efficacy of antibiotics in clinical trials. Meeting that heightened burden of proof meant, in certain instances, substantially increasing trial size and duration-leading some drug companies to drop particular development programs, and even pare back on their development of antibacterials altogether. At the time, the FDA's treatment of antibiotics seemed, to many, part of a broader trend towards a more cautious and conservative approach to drug approval. But it turns out that rather than evidencing a concerted agency effort to more closely scrutinize the effectiveness of antimicrobials, the new policy was apparently instituted by a statistical-minded faction within the FDA whose influence shot up in the absence of strong central leadership. Indeed, that intra-agency power balance has now apparently shifted in favor of medically oriented officials who are more sympathetic to the practical problems faced by antibiotic drugmakers. But while pharmaceutical company officials voice optimism that they will be able to work out a reasonable new set of efficacy guidelines with the FDA, there's a lingering concern that the power vacuum at the top of the agency will continue to create uncertainty and unpredictability for an industry whose long-term development cycles make it so dependent on regulatory consistency.

The FDA and Antibiotics: An Unsettled Agency of Many Minds

About two years ago, the FDA began tightening the statistical standard that companies must meet to demonstrate the efficacy of antibiotics in clinical trials. Meeting that heightened burden of proof meant, in certain instances, substantially increasing trial size and duration-leading some drug companies to drop particular development programs, and even pare back on their development of antibacterials altogether. At the time, the FDA's treatment of antibiotics seemed, to many, part of a broader trend towards a more cautious and conservative approach to drug approval. But it turns out that rather than evidencing a concerted agency effort to more closely scrutinize the effectiveness of antimicrobials, the new policy was apparently instituted by a statistical-minded faction within the FDA whose influence shot up in the absence of strong central leadership. Indeed, that intra-agency power balance has now apparently shifted in favor of medically oriented officials who are more sympathetic to the practical problems faced by antibiotic drugmakers. But while pharmaceutical company officials voice optimism that they will be able to work out a reasonable new set of efficacy guidelines with the FDA, there's a lingering concern that the power vacuum at the top of the agency will continue to create uncertainty and unpredictability for an industry whose long-term development cycles make it so dependent on regulatory consistency.

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