New Drug Approval Rate - Not What it Used to Be

In news that doesn't surprise most of us who have been watching FDA approvals, it would appear that someone has gone and counted up the approval rate and the rate of approvals for new drugs has, in fact, gone down. 

This news comes on the heels of the issuance of yet another approvable letter by the FDA, this time to Indevus Pharmaceuticals, Inc. for Valstar, a bladder cancer treatment that had been approved, but was subsequently withdrawn from the market due to impurities.   According to the Chairman and CEO of the company, "The FDA requests in the approvable letter are easily addressable with existing data and the completion of a few brief process related investigations. We expect to supply the FDA with a complete response within the next two months. We remain on track for a late 2007 or early 2008 re- introduction."  No more specificity was offered in the company release. 

The Associated Press story on the FDA slowdown of the pipeline quotes FDA spokesman Christopher Kelly to say that "There have been no systematic changes in how we are approaching the approval standards for new applications." "Whether the current public debate and criticism of FDA on drug safety has played any role in our actions is very hard to quantify."

It may be true that it is hard to quantify, but my gut tells me that it is undeniable.  I also think that it makes sense given the pounding that the agency has taken from policy makers on the Hill as well as in the media and by critics.  That said, rather than say it is hard to quantify, I think that both patients and investors might benefit from the FDA attempting to quantify the issue and then explain what the new rules of the game are going to be.  As it is, expectations of both patients and investors are in alignment with a reality that may no longer exist. 

Comments

[emjeff]

Does this mean another round of hearings on the Hillthis time asking "Why isn't the FDA getting these live-saving drugs to the people?"

[Mark Senak]

That would be hard to say since Congress has been part of the problem - people have to make up their mind. Do they want to beat the agency up for not getting out drugs fast enough, or do they want to beat the agency up because it takes more time to examine safety and efficacy issues? Can't have it both ways, even if you are a member of Congress.

[Rob Camp]

I have only been following FDA on and off for 15 years, and super-seriously for less than 5 (4 and a half) - and almost always in HIV, but I suspect that it (the dropping numbers of approvals) is, along with FDA's reticence to screw up, the pharmaceutical industry's laziness - an indicator might be that more than 50% of the post marketing studies agreed to by industry, are not done.

Whatever the industry's investment in research is, however you want to analise it, why not continue what needs to be done all through Phase III and into Phase IV? (adverse events, long term events, etc) You'll have a more trustworthy drug. What's the secret? As long as there are important data unknown, there will be a distrust in the industry that promulgates these less then complete data...

[Mark Senak]

I agree that the Post-Marketing track record is not one that lends itself well to supporting credibility, but I don't know that I agree it is a factor here. The slowdown has been sudden I think. We may have to see how things go in the post-PDUFA era once the bill is finally passed.

[Cary]

I believe that the slowdown is due to the huge magnifying glass the FDA has been under recently. However it baffles me as to why they wish for faster approvals to heal sick patients, but then the Federal appeals court won’t make a drug-rule exception for dying patients.

From the LA Times:

Dying people do not have the right to obtain unapproved drugs that are potentially lifesaving, even if their doctors say the treatment offers the best hope for survival, a U.S. appeals court in Washington ruled Tuesday. In an 8-2 decision, the court said federal drug regulators are entrusted by law with deciding when new drugs are safe for wide use.

Food and Drug Administration approval of drugs generally requires testing that can involve years of trials and thousands of patients. The families of terminally ill patients, several of whom died after they were denied promising drugs still being tested, filed the lawsuit. They said dying patients were far more willing to take risks and should not be forced to wait for new treatments to win final FDA OK.

Good news, the U.S. Congress is poised to pass a bill that would give the U.S. Food and Drug Administration the authority to regulate tobacco. As if they are not already overwhelmed. This should speed things up.