Is FDA Most Science-Based and Less patient Centric Now that Gottlieb is in Charge?

Last October, FDA caved in to patients lobbying on behalf of Sarepta’s Duchenne drug Exondys 51 despite the fact that there was little scientific evidence that it was effective (read “FDA Succumbs to Industry-Sponsored Patient Power & Accelerates Approval of Sarepta’s Duchenne Drug“).

Now, another company — PTC Therapeutics — is seeking approval for a competing drug and the FDA warned in a briefing document that it the company should not depend on the same tactics to get its drug approved. Will paid patient lobbyists sway FDA just like they did for Sarepta? Or is the FDA now more science-based that Gottlieb is in charge? For more, see story embedded below.