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FDA matches most new drug approvals in years in 2012, but is it enough?

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The FDA has highlighted the agency's 35 new drug approvals in fiscal year 2012 and its track record for beating regulators in other countries as the first to green-light therapies three-quarters of the time.

The approvals match the total in the previous fiscal year ending in September, and there are plenty of victories to celebrate in the agency's data, yet it's an open question whether biopharma companies are advancing enough new drugs to the market amid some troubling economics for the industry.

FDA approvals provide a key metric for the health of the industry because the U.S. is the largest national pharma market and the agency's stamp carries weight around the world. As of the end of November, The Wall Street Journal reported, U.S. regulators had stamped approvals on 31 new medicines in calendar year 2012 with a month left in the year for that number to grow. And the new therapies include pioneering rare disease treatments such as Vertex Pharmaceuticals' ($VRTX) cystic fibrosis drug Kalydeco and the breast cancer therapy from Roche ($RHHBY) called Perjeta, both of which received priority reviews from the agency.

The levels of new drug approvals in the two most recent fiscal years reach a level not achieved in several years at FDA, which critics have targeted (unfairly or not) for slowing progress in biopharma. What's behind the turnaround in recent years? Well, the agency has stepped on the gas a bit with expedited reviews for new therapies that address major needs for patients with cancer and other deadly diseases. The agency is hitting its action-date deadlines for applications in most cases, and companies are doing their part by advancing programs to the review stage.

This is good news for the industry, which needs novel drugs to hit the market in greater numbers than in past years to make up for lost revenue from old brands that have fallen off patent and for the downward pressure on drug pricing. As Thomson Reuters and Deloitte noted in an analysis revealed this week, the average forecasted revenues of products from 12 major drugmakers has fallen in recent years.

As good as the FDA's approval totals seem, drugmakers need to get more new meds across the finish line--more quickly. Yet the agency has shown a willingness to do its part.

- download the FDA's report (PDF)
- see the WSJ article (sub. req.)
- check out Forbes' report
- and Bloomberg's article

Slideshow: FDA approvals of 2011

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