Good data = faster approvals with Trump FDA
The FDA Is Approving Drugs at a Staggering Pace
October 6, 2017, Bloomberg
The U.S Food and Drug Administration, under Commissioner Scott Gottlieb, is taking advantage of policy groundwork laid in past years to speed drug approvals. Thirty-four new drugs -- treating everything from cancer to rare genetic diseases -- have been approved so far this year. That’s on pace to nearly double last year’s approvals. So far, at least nine decisions came more than 20 days ahead of the FDA’s scheduled action date.
Wall Street is paying attention, with some portfolio managers shifting their strategies, anticipating faster approvals and less restrictive labels.
The agency stresses that the changes to increase speed aren’t at the expense of safety.
“The FDA makes decisions based on consistent, rigorous scientific principles,” said spokeswoman Sandy Walsh in an email. “We’re always implementing reforms to modernize and strengthen how we determine safety and effectiveness, while also making the drug development and review process more efficient.”
As part of their Drug Competition Action Plan, officials with the FDA have announced additional steps to encourage competition in the generic drug market, according to a statement from FDA Commissioner Scott Gottlieb, MD.1
Good Data
Joep Muijrers, a partner at investment firm LSP adds a word of caution to eager investors -- “You still need to show convincing data,” said Muijrers. “If you’re saying, let’s go to the FDA with a sub-optimal data set and get approved -- I don’t think that’s going to happen.”
“We are more ready to give the benefit of the doubt toward approval rather than disapproval,” he said. “There’s not only a higher probability of approval, but of a broader, more expansive label.”
