FDA approves fewest novel drugs in 24 years: reports

Share this article:
The FDA approved 19 novel drugs last year, the lowest number since 1983, according to published reports.

That total included 17 new molecular entities and two biotech drugs. The tally was conducted by Ira Loss, who tracks the FDA for a group called Washington Analysis, Bloomberg News reported.

GlaxoSmithKline and Novartis led the industry with two approvals apiece. The FDA hasn't tallied the approvals for last year and couldn't confirm the number, agency spokesman Christopher DiFrancesco told Bloomberg.com. He said he wasn't sure when the agency's annual data on new drug applications and approvals would be ready.

The FDA hasn't changed its approval standards, Janet Woodcock, the agency's deputy commissioner, told Bloomberg.com in an e-mailed response to questions.

The number of marketing applications for novel drugs has declined in recent years, and the agency is better able to detect risks, she said. “Our standards for what constitutes a safe, effective drug have not changed,” Woodcock said. “But our ability to analyze data for potential safety problems has improved, and we're especially vigilant when we're evaluating drugs for chronic conditions -- drugs that people will be taking daily for many years.”

Share this article:
You must be a registered member of MMM to post a comment.

Email Newsletters

More in News

Five things for Pharma Marketers to know: Friday, August 29

Five things for Pharma Marketers to know: Friday, ...

Takeda closes out a good-news, bad-news kind of week, AstraZeneca adds a new clinical trial for its experimental PD-1, and researchers link a funeral to the Ebola outbreak.

Amgen sends PCSK9 to FDA

Amgen sends PCSK9 to FDA

Evolocumab holds the FDA's first filed biologics license application for the class.

Consultants expect M&A tempo to continue

Consultants expect M&A tempo to continue

PwC anticipates that divestitures will fuel late-2014 deals, but notes that the noise around early deals and the financials don't fully match up.