FDA's Approvable Problem - Pharmaceutical Executive

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FDA's Approvable Problem


Pharmaceutical Executive


To Jenkins, the conventional wisdom on approvable letters gets the story backward. "It's probably true that we have been issuing more approvable letters recently, but in most cases that is a shift from what would have gotten a nonapprovable letter before," he said. If anything, "approvable" status means the drugmaker doesn't have to submit a whole new application, a bonus for pharma.

"In some cases, companies are looking for convenient explanations for not getting their applications approved," Jenkins added.

Jenkins can be forgiven for sounding a little gruff. The controversy over approvable letters has emerged on the heels of months of public excoriation of FDA's safety-monitoring failures and debate on how to "reform" the agency. Suddenly the media were painting FDA as an agency too browbeaten to approve drugs. Needless to say, these articles didn't carry headlines like "Newly Safety-Conscious FDA Stands Up to Industry Ire." Interestingly, of the 12 or so NDAs approved since late August, as the "slowdown" controversy gain traction, only one got an approvable letter.

A New Fulcrum for the Seesaw


Steve Brozak, Analyst
But what about the accusation that FDA is basing decisions on politics not science? Jenkins framed his answer carefully. "We at FDA reflect the approval standards that we hear from Congress and the public. We can set the bar wherever they tell us to, though the pros and cons of any change must be carefully weighed," he said. "And some people would say that to do otherwise would be irresponsible of us."

In other words, it's true—a new, more cautious mind-set has taken hold at FDA, and given the chances of a Democratic presidential victory in '08, it's no temporary trend. "I would not be surprised if the decisions we make now are different from decisions we would make in the past when looking at the same set of data," Jenkins said.

Jenkins may not be surprised, but drugmakers are—or claim to be. A recent First Albany Capital report notes that "the FDA's tolerance of [safety signals] appears to have declined," resulting in "unsettling surprises."

"I can't believe they weren't anticipating that things were going to get tougher," said Chris Milne. "But knowing things were going to get tougher and dealing with it are two different things."

In the first place, it's common knowledge that the speed with which FDA approves drugs goes in cycles. The regulatory barriers to approval move like a pendulum, rising and falling based on pressure from Congress, advocates, and, yes, even industry. "There is no constant, quantifiable bar for either safety or efficacy," said Ken Kaitlin, who heads the Tufts Center for the Study of Drug Development. "Where FDA puts the balance between the two is really a public decision."

That's why Kaitlin believes that this is a "he said, she said" in which both pharma and FDA are right. "FDA's standpoint is that it's doing the same thing it has always done—but just using a new fulcrum for the seesaw," said Kaitlin. "But from pharma's side, FDA has indeed raised the bar because now a drug needs to show a lot more weight in efficacy to offset the risks."

Chris Milne dates the swing toward safety to the agency's recall of Warner-Lambert diabetes drug Rezulin in 2000 due to liver fatalities—a debacle that featured both incompetence (three label changes) and intrigue (studies that the safety office kept secret from the rest of the agency). "After that, FDA did a self-analysis and instituted some changes to the way they review submission packages," said Milne. "So drugmakers may have been able to predict that this was all going to happen."


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