Advocates Fault FDA's Plan To Replace Detailed, Individual Reviews Of New Drugs With Summaries

“These reviews are often the best, and sometimes the only, place that members of the public can get critical data on the risks and benefits of drugs. They’re also a vital window into the FDA, as they explain why the FDA concluded that each approved drug was safe and effective,” said Christopher Morten, a fellow at New York University's School of Law. Pharmaceutical news focuses on a potential rival to Roche's MS drug, as well.

A Food and Drug Administration proposal to substitute detailed reviews of new drugs written by specific agency teams with an abbreviated summary is prompting strong protests from academic researchers and public advocates who claim the move is “ill conceived” and will harm public health. Last June, the FDA issued a notice describing plans to do away with a longstanding practice of posting on its website separate reviews concerning pharmacology, medical chemistry, risk assessment, and biostatistics issues, among other things. (Silverman, 8/29)

Swiss drugmaker Novartis on Friday stepped up its challenge to Roche's multiple sclerosis franchise, highlighting study results for its MS hopeful ofatumumab that could compete with its cross-town rival's drug Ocrevus. Novartis said ofatumumab, already approved as Arzerra to treat leukaemia, reduced annual relapses better than Sanofi's Aubagio in two head-to-head late-stage studies against relapsing forms of MS (RMS). Detailed study results are due at an MS conference in Sweden next month. (8/30)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

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