While the Agency continues to maintain it is doing nothing differently, every drug maker in the country (innovator or generic) realizes this isn’t the case. The FDA approved only 18 novel products in 2007, the lowest number in at least a decade. And the backlog of generic applications is astounding.
The latest victims were last week’s double rejection of mipomersen from Isis Pharmaceuticals/Genzyme and Cordaptive from Merck. To an observer, it looks like a double homicide.
The FDA seems to be demanding new data on safety and efficacy that was not included in the initial trial design discussions. While this is new for manufacturers of primary care products like cholesterol medications, it is nothing new to researchers of cancer vaccines. For years, the FDA has changed standards on researchers mid-stream, including revisions on primary and secondary endpoints.
The main issue is whether any of this will actually make products safer…or more effective…for patients.
