Skip to content

FierceBiotech – Spike in approvals can't quell industry complaints about FDA

FierceBiotech – Spike in approvals can't quell industry complaints about FDA


Throughout 2011 you could hear a growing chorus in the biopharma industry

 complain bitterly about the tougher regulatory challenges facing drug developers. Antibiotics got tougher. Diabetes [1] got tougher. Obesity [2] was always a tough nut to crack, and there were three biotechs this year that showed just how hard it can be.

The FDA responded. Throughout the course of the year top regulators at the agency like Janet Woodcock periodically defended the agency, pointing to new studies showing that the FDA was faster than the Europeans when it came to drug reviews. By the middle of the year, regulators started to point to a growing number of approvals, promising a likely spike in new drugs headed to the market this year.

By November the FDA had 35 approvals [3] to boast about–with 24 coming ahead of any OKs in other countries. The agency publicly noted that 2011’s approval rate will go down as one of the best years in the past decade after years of anemic approval rates.

Interestingly, I don’t know of anyone in the industry who thinks the spike in approvals this year represents a major change. Most industry execs I talk with just don’t believe we’ve turned the corner on productivity. And they may well be right. Smart developers at companies like Bristol-Myers Squibb ($BMY [4]) and Roche [5] may have proven their R&D and regulatory teams know how to deliver the goods, but with the industry undergoing an unfinished revolution on the development front, next year could see a drop in approvals. And if that happens, the FDA will be under even more pressure to work more closely with the industry on elaborating just how developers can stack the odds in their favor.