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New metrics to factor into drug approvals
Restoring public confidence in the FDA is among her top objectives, says recently installed commissioner Margaret A. Hamburg, MD. On the drug side, that’s likely to mean a reassessment of drug-approval processes, though perhaps not as great a departure as many critics contend. There have been growing signs prior to Hamburg’s appointment that the FDA was reevaluating its processes anyway, prodded by Congress and patient groups on one side and by globalization forces—in the form of regulatory harmonization and the foreign multitudes supplying the US market—on another. A push from Hamburg now can only accelerate the process.
She advocates a “public health approach,” meaning “fulfilling society’s interest in assuring the conditions in which people can be healthy,” according to Hamburg and principal deputy commissioner Joshua M. Sharfstein, M.D., in an article that appears in the online New England Journal of Medicine. It is slated for publication in the June 11, 2009, print edition.
The FDA’s job, she writes, is to promote health, prevent illness, and prolong life. “The ultimate measures of the FDA’s success should reflect its fundamental goals and go beyond such intermediate measures as the number of facilities inspected or drugs approved.”
The potential good of a new drug or policy must be balanced against the potential harm, she writes. “Some benefits are not worth the risk; some risks are worth taking.” Key considerations are the severity of the illness and availability of alternative treatments or preventive interventions. “As a public health agency, the FDA should always ask whether delays in approval or safety problems can be prevented,” she adds.
Hamburg notes some wiggle room in the drug approval process from the FDA Amendments Act of 2007, which allows restrictions on the use of medications at the time of approval while requiring that additional safety data be gathered. “These tools allow the FDA opportunities to change the regulatory oversight of products as they move from limited use in clinical trials to adoption in the medical system. The ability to detect and act on safety signals quickly can give an additional layer of confidence to support earlier approval of important medications,” she writes.
And prompted by efforts at the International Conference on Harmonization, the FDA recently accepted two proposals from Genentech (South San Francisco) for use in a pilot program intended to test quality by design concepts, which hold promise in streamlining regulatory approvals internationally. The filings are part of an effort in which Genentech is working with the FDA on a QbD case study as part of the regulator’s Critical Path Initiative, according to a Genentech presentation at the recent BIO show in Atlanta. The case study involves simultaneous filings in the U.S., the European Union, and ICH regions.