FDA says its drug approval rate is unchanged But what s entering the market?

By ACSH Staff — Mar 18, 2011
Perhaps responding to ACSH’s Director of Chemical and Pharmaceutical Sciences Dr. Josh Bloom’s op-ed on the effect of the FDA’s overly-precautionary regulations on the pharmaceutical industry, the FDA is countering claims that it is not approving enough drugs. The agency published a statement arguing that the number of approvals for novel drugs, called new molecular entities (NMEs), has remained stable over the past decade.

Perhaps responding to ACSH’s Director of Chemical and Pharmaceutical Sciences Dr. Josh Bloom’s op-ed on the effect of the FDA’s overly-precautionary regulations on the pharmaceutical industry, the FDA is countering claims that it is not approving enough drugs. The agency published a statement arguing that the number of approvals for novel drugs, called new molecular entities (NMEs), has remained stable over the past decade. Instead, the FDA blames the failure to approve more drugs on the pharmaceutical companies, who they say are filing fewer NME applications. The agency approved 23 applications last year, which is half the number approved 15 years ago.

“Funny numbers,” says Dr. Bloom, who is not buying the agency’s explanation. “There are drugs, and there are drugs. Looking at the 21 NME’s the FDA approved last year, it is obvious that many of these medicines are for niche conditions that will be useful for very few people. The only likely blockbuster drug approved was Novartis’ Gilenyia, the first oral MS drug, and maybe Boeringer’s Pradaxa, which is a blood thinner. There was only one new antibiotic approved. The list is not impressive. Interestingly, no single company had more than one drug approved, and Merck and Pfizer had none.”

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