New US FDA chief should have medical experience

Bloomberg

President-elect Donald Trump’s pick to lead the US Food and Drug Administration should have a medical background, and the agency should continue evaluating new medications’ effectiveness, drugmaker executives said in comments indicating opposition to two candidates for the regulator’s top post.
Trump’s FDA chief should be a doctor or physician-scientist with experience in clinical care and medical research, said Roger Perlmutter, head of research and development for Merck & Co. The president-elect is considering appointing former biotechnology industry executive Balaji Srinivasan and Jim O’Neill, a Silicon Valley investor, according to people with knowledge of the matter. Neither has a medical background, and O’Neill has suggested that the FDA should focus solely on new drugs’ safety, leaving the market to decide whether they work.
“We’d want someone in that position who is knowledgeable about drug development or patient care,” Perlmutter said Jan. 9 in an interview at the J.P. Morgan Healthcare Conference in San Francisco. “We wouldn’t want somebody in there who didn’t have that level of understanding, but they could come from a lot of different environments,” such as public health, he said.
Trump will be sworn in on Friday as president, and big pharma companies are closely watching his administration’s appointments as he continues to roil the industry, telling the Washington Post on Sunday that he will continue to target high drug prices.
Srinivasan and O’Neill, both associates of venture capitalist Peter Thiel, who’s advising Trump on science and technology, have criticized the FDA on Twitter and in speeches. Representatives of the Trump transition team didn’t immediately respond to an e-mailed request for comment.

AGENCY CRITIC
Srinivasan, whose 21 Inc. startup got funding from Thiel, earlier co-founded Counsyl Inc., which makes a pregnancy test to quickly detect Down syndrome and other severe, chromosome-related birth defects. He is no longer with the company, Counsyl said.
Srinivasan has been a critic of government in general and of the FDA in particular. His posts to Twitter attacking the agency have been deleted since his consideration became public last week. In an Aug. 13 tweet that’s been removed, he wrote, “FDA bears responsibility for many deaths. Blocked many good drugs.”
O’Neill, a managing director at Thiel’s Mithril Capital Management, served in George W. Bush’s administration as principal associate deputy secretary in the Department of Health and Human Services.
Allowing the FDA to approve drugs based only on safety, as O’Neill has suggested, would be a setback for the agency and for health, Ovid Therapeutics Inc. Chief Executive Officer Jeremy Levin said in an interview. One of the FDA’s most important functions is determining whether drugs work, he said.

INSURER OVERSIGHT
“If there is any attempt to change the mission of the FDA — in other words, to prove both safety and efficacy — then America’s primacy in drug discoveries will suffer,” Levin said. “Any person who comes to run it needs to understand the value of clinical trials, the value of not just proving safety, but proving efficacy.” Takeda Pharmaceutical Co. will continue developing drugs with the expectation that the FDA won’t change its mission, said Ramona Sequeira, president of US operations for the Japanese drugmaker. “We spend a lot of time testing both the efficacy and safety of our drugs and have a full expectation to demonstrate both,” she said in an interview.
Limiting FDA’s purview to drug safety is worth exploring, said Mark Baum, CEO of San Diego-based Imprimis Pharmaceuticals Inc., which makes compounded drugs. Insurers, the gatekeepers for much of patient care, already monitor drug efficacy, he said.
“There is some wisdom in thinking about whether we want the FDA in the efficacy business at all,” he said in an interview. Appointing either Srinivasan or O’Neill to head the agency would be a significant departure from tradition. For decades, trained physicians or prominent scientific researchers have overseen the FDA, widely considered the final word on safety of drugs for human health.
The current head, cardiologist Robert Califf, was a founding director of the Duke Clinical Research Institute. Scott Gottlieb, a physician who’s a former senior official at the FDA and a resident fellow at the American Enterprise Institute, a conservative
think tank, is also said to be under
consideration.