Surprise! Drug Approvals Increase in 2008
This article was originally published in RPM Report
Executive Summary
Its official: FDA's drug center has already approved more new molecules in 2008 than it did in 2007-despite missed user fee deadlines, a regulatory posture defined as "Safety First" and a general perception that it's never been harder to get drugs to market. Maybe there is an upside to the new regulatory system after all.
Surprise! Drug Approvals Increase in 2008
Its official: FDA’s drug center has already approved more new molecules in 2008 than it did in 2007—despite missed user fee deadlines, a regulatory posture defined as "Safety First" and a general perception that it’s never been harder to get drugs to market. Maybe there is an upside to the new regulatory system after all.
We all know the story: Missed user fee deadlines. Multiple cycle reviews. A regulatory posture defined by the phrase "Safety First." Complex new legislation. Understaffed, overworked review divisions. A hostile Congress eager to second-guess any and every decision. Divergent viewpoints built into the review process. Demands for more advisory committees with fewer conflicts of interest. (Also see "Running Late: FDA Review Timelines Lengthen For New Product Applications" - Pink Sheet, 1 Sep, 2008.)
No wonder it is harder than ever to get drugs through FDA.
Maybe not.
The approval of Eisai Co. Ltd. ’s anti-seizure medicine Banzel (rufinamide) on November 14 marked a quiet milestone for FDA’s Center for Drug Evaluation & Research, the group charged with reviewing all new drugs and most therapeutic biologics: it was the 18th new molecule approved by the agency this year.
That matched the full-year tally for 2007, and then with two more approvals the week of November 21, CDER officially moved ahead of last year’s total, with six weeks still left in the year.
Of course, 2007 was the single worst year for new drug approvals in a quarter century, so improving on that performance is hardly cause for a parade. (Also see "Turning Back the Clock: Drug Approvals Hit 25 Year Low" - Pink Sheet, 1 Jan, 2008.)
But it is good news nevertheless. As recently as July, it looked like FDA might be on track for yet another new low in output: with only six approvals in the first half of the year—one fewer than the first half of 2007. (See "For NME Approvals, 2008 Looks a lot Like 2007," The Pink Sheet, Aug. 18, 2008.)
The pace has picked up. In fact, it may turn out that 2008 is the best single year for approvals since 2004. (CDER approved 36 novel products that year. Don’t expect the agency to come close this year.)
Even a really strong finish by FDA in 2008 wouldn’t mean that much in the grand scheme of things. After all, 2004 was just a one-year blip in what has been a prolonged drought in new product approvals—at least compared to the 1990s. What industry needs is not one big year, but a long-term, sustained increase in the output of new products coming to market. (See "The Blockbuster Bubble," The RPM Report, February 2008). (Also see "The Blockbuster Bubble: What is the Real Trend in R&D Output?" - Pink Sheet, 1 Feb, 2008.)
Still, the thought that FDA will end up approving more drugs this year than last offers a much needed sign of hope for the biopharma industry. Maybe—just maybe—the new era in drug regulation ushered in by the FDA Amendments Act of 2007 won’t be so bad after all.
Industry accepted FDAAA as a tough but necessary trade, hoping that the tighter safety regulation would give FDA more confidence to approve drugs that would otherwise languish at the agency. There’s no question about the tougher regulation: about one-third of new molecule approvals have a formal Risk Evaluation & Mitigation Strategy attached to them, and more than half have mandatory post-marketing study requirements. (See "The Impact of FDAAA on Drug Approvals.") (Also see "The Impact of FDAAA On Drug Approvals: Setting the Baseline" - Pink Sheet, 1 Nov, 2008.)
It’s impossible to say for sure whether the other half of the trade will come to pass, but at least the trend is in the right direction.
In fact, Banzel may be the perfect emblem for the year 2008. It was a multi-cycle review (the application was first submitted almost exactly three years ago); it slipped passed the second review deadline (Eisai’s resubmission was due for action on August 29); and the approval carries with it a formal REMS requirement as well as some mandatory post-marketing trials.
But it is approved for marketing. And, despite everything, that is something that seems to be happening a bit more often this year than last.