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.No wonder it is harder than ever to get drugs through FDA.
Maybe not.
The approval of Eisai’s antiseizure 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 is the 18th new molecule approved by the agency this year.
That matches the full year tally for 2007, and there are still six weeks left in the year. [UPDATE: With two approvals in the 24 hours since this was first posted, FDA is now at 20 new molecules for the year.]
Don’t run out and buy all the champagne quite yet: remember, 2007 was the single worst year for new drug approvals in a quarter century. Matching that performance is hardly cause for a parade.
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.
Well, the pace has picked up (as we predicted it would). And with at least 10 more applications still pending with a shot at approvals this year, 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 miracles: five or six more approvals maybe, but 18 more approvals in the next six weeks is out of the question.)
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.
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: as “The Pink Sheet” reported, 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.
Its 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 final review deadline (Eisai’s resubmission was due for action on Aug. 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....
While every NME approval is cause for rejoicing, we should be cautious about reading too much in the tea leaves, or, in this case, in the significance of Banzel's approval. One should point out that, among the 18 NME approvals for this year, there is one imaging agent (Iobenuane I 123, GE), and one peginterferon + ribavarin combination treatment for hepatitis C, which is hardly a new idea. The number of novel therapies approved so far in 2008 is therefore 16, with only 4 of these going to big pharmas. It is hard to argue with such statistics that R&D productivity is on the rebound. It is not, and the industry continues to face an acute problem of sustainability.
ReplyDeleteThanks for the comment. I quite agree that this is no sign that the Big Pharma R&D productivity problem has been fixed.
ReplyDeleteA couple of points on the approval tally. First, there are in fact three imaging agents included in that total, so in that sense the number of therapeutics is even lower.
On the other hand, I did not include the Peg-Intron combo in the tally--and FDA has approved two more new molecules since the post was first published. So there really are 20 new molecules approved by the drug center this year. (And 17 new therapies, if you exclude the imaging agents).
On the third hand, some of those "new" molecules aren't so new--Pristiq for instance. That isn't any different than prior years, but it is one reason we try to track our own metric: Innovative Commercial Therapies. We'll publish that count at the end of the year.
The increase in new drug approval in 2008 has lead me to two interpretations- FDA with all the blames and criticisms over there head, finally decide to lax there standards or pharma companies are prudently submitting more relevant and efficient drug safety data’s (or might be taking less risky candidates for approval).
ReplyDelete