The former FDA deputy commissioner Scott Gottlieb writes in The Wall Street Journal that the recent panel vote against Merck's Arcoxia is creating new ground rules for a drug approval that is spurring developers to review their pipeline projects. The agency's goal had been to expand the number of therapies available to treat a therapy as long as they were safe. But the 20-1 vote against Arcoxia, writes Gottlieb, is a clear indication that that approach is no longer operational. Gottlieb, now a resident at the conservative American Enterprise Foundation, harshly criticizes the FDA panel, which he says is moving away from the principle that a larger number of drugs will improve a patient's chances of finding one that is most suitable for him. If the FDA intends to require developers to demonstrate superiority of a new drug in a certain subset of patients, it will seriously hinder new product approvals.
- read the commentary from The Wall Street Journal
- see last week's release on the FDA's decision