FDA Becoming Conservative? Not So Fast

I have attended a number of meetings and panels of late and keep hearing the same thing over and over: FDA is more conservative. It seems that every speech starts: "With a more conservative FDA..."

I'm not so sure.

There are some developments that could lead one to say FDA is becoming more conservative, such as the recent creation of an Office of Drug Safety and the choice of a new director for that office.

http://www.fda.gov/bbs/topics/news/2005/new01245.html

But if you look more closely, the office will fall under the purview of the Center for Drug Evaluation & Research and the new director ultimately reports to CDER chief Steve Galson. Moreover, the new ODS Director - Gerald Dal Pan - is only a few years removed from the industry he helps to regulate now. Dal Pan formerly oversaw clinical research for Guilford Pharmaceuticals. He left that post in 2000 to join the agency.

And take a look at the new interim FDA Commissioner. Andrew von Eschenbach is most known for saying that his goal as the head of NCI is to have a cure for cancer by 2015.

So he has a meager 10 years left to accomplish that feat.

[If what FDA says and does matters to you, then make sure to attend the upcoming FDA/CMS Summit Nov. 29-Dec. 1 in Washington, D.C. A number of FDA topsiders and former FDA decision makers will be there to tell you their priorities in 2006 and help you find your way through the regulatory maze.]

Review times certainly haven't skyrocketed and the agency is looking for more ways to speed up reviews, such as rolling review under its Pilot 1 program, which could be made permanent under PDUFA IV.

Merck's Vioxx clearly has created the environment for people to say FDA is becoming more conservative, but that doesn't mean that they are. The agency's Endocrinologic & Metabolic Drugs Advisory Committee just voted in favor of approving Pfizer's inhaled insulin drug Exubera, a product that has a decade-old safety history. The Oncologic Drugs Advisory Committee just recommended accelerated approval for Celgene's Revlimid for a type of blood cancer known as MDS. Revlimid is a cousin of thalidomide, one of the more dangerous drugs out there and that has been used in over 130,000 Americans to date.

Even if you take a look at the COX-2s and NSAIDs, Pfizer's Celebrex remains on the market, although with a black box warning, as do all other prescription NSAIDs.

If you take a step back and look at the key personnel at FDA, the players are still the same: Janet Woodcock, Bob Temple, and Galson among others.

I think the real issue for discussion is Big Pharma's pipeline. It's not that FDA is becoming more conservative, it's the pipeline of drugs leading into the agency.