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.”
