Editorials Look at FDA Fast-Track Approval for Treatments for Bioterrorism Related-Diseases
The FDA's decision to allow approval of certain drugs that would protect people from biological, chemical or nuclear attacks without requiring clinical trials in humans "makes sense," even if the process is not "foolproof," the New York Times writes in an editorial. Although the decision could place the American public in the "uncomfortable position" of "betting their lives on unproven remedies," such a situation is preferable to asking some people to volunteer to be exposed to deadly agents, according to the Times. The Times notes that even consumer advocates who act as watchdogs over the FDA agree the new rules are sensible, as long as they are used sparingly and not allowed to become a "loophole" for a quicker overall approval process. The editorial concludes, "[T]he new policy seems the best way to proceed in an age of terrorism. There is simply no ethical way to conduct the clinical trials that are traditionally required to prove a drug's efficacy" (New York Times, 6/3).
A Wall Street Journal editorial calls the FDA's decision "one of the more enlightened steps it has taken" since allowing fast-track approval of drugs, adding that the "only thing that would thrill" the editorial board more would be for the FDA to decide to apply the new rules for bioterror medicines "to more areas of treatment." According to the editorial, the FDA could "do more for public health" by eliminating "hyper-technical efficacy tests" after studies have proven a drug's safety, relying instead on a "system that weighs relative risks and benefits." The editorial concludes, "This new rule should be the starting point for all drug approvals" (Wall Street Journal, 6/3).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.