Good News For Pharma Stocks: FDA Drug Approval Speedier
For those wondering whether the FDA could really respond to demands for increased drug approvals while also balancing safety concerns, an answer has arrived. Last year, the agency approved 39 new medicines, a level not seen in 16 years. The tally includes 11 new cancer treatments and at least 10 of the drugs had received a so-called fast-track approval status.
The approval rate, which contrasts with 30 in 2011 and just 21 in 2010, comes shortly after John Jenkins, the director of the Office of New Drugs at the FDA Center for Drug Evaluation and Research, told an industry conference that the FDA has been meeting or exceeding nearly all PDUFA goals for application review. PDUFA, you may recall, refers to established deadlines (read earlier Pharma news).
The implications, of course, are favorable for the pharmaceutical industry, which has complained bitterly in recent years that the FDA has been too slow to issue approvals in the wake of several safety scandals, an accusation echoed, at times, by some Republican members of Congress and patient advocacy groups.
Now, though, various drug makers are poised to ring the register with a growing number of approvals, including eight issued last month alone. These included a new medicine from Johnson & Johnson (JNJ) called Sirturo for drug-resistant tuberculosis, the first new TB drug in decades, and Eliquis, the latest in a new round of blood thinners that is from Pfizer (PFE) and Bristol-Myers Squibb (BMY). New drug approvals could help the industry get revenues growing again.
To read the remainder of this article, go to Pharmalot.Ed Silverman, a contributing editor of YCharts, is the founder and editor of Pharmalot. He previously reported on the pharmaceutical industry and other business topics for the Star-Ledger of New Jersey, New York Newsday and Investor’s Business Daily. He can be reached at email@example.com.