March 8, 2017 – In an open letter to President Donald Trump, Pharmalot’s Ed Silverman asks that before Trump criticizes and plans any reform of the Food and Drug Administration (FDA), he should take a hard look at how the agency has performed in recent years.

“During the past decade, the FDA has increasingly used various tactics to speed approvals of medicines that work in new ways. Last year, 73 percent of the so-called novel drugs were approved using programs such as fast track or breakthrough designations, up from 66 percent in 2014,” Silverman wrote in a March 6 post.

“And here are more figures to consider: Between 2003 and 2010, 23 cancer drugs were approved by both the FDA and European Medicines Agency, but the median review time by the FDA was 182 days — compared with the 350 days taken by European regulators,” he noted.

Silverman called out Trump for pointing to a woman with Pompe disease during his address to Congress and saying that the FDA “keeps too many advances, like the one that saved [her] life, from reaching those in need,” when in fact, the drug in question was approved in nine months after a clinical trial of just 39 patients. “That’s hardly an example of slow and burdensome,” Silverman stated.

He cited other statistics and examples in support of the FDA’s strong performance, and stated that any notion of Trump appointing crony Peter Thiel’s friend Jim O’Neill to the FDA Commissioner position, when O’Neill has no medical background, is “reckless.”

“Your sound bites may appeal to anyone frustrated with bureaucracy. But if anything is burdensome, it is your misguided notion of improving public health,” according to Silverman.

To read the full post, go to: https://www.statnews.com/2017/03/06/trump-fda-misguided/