January 16, 2017
By Alex Keown, BioSpace.com Breaking News Staff
NEW YORK – Balaji Srinivasan, the co-founder of Counsyl Inc., a company that developed a pregnancy test to determine birth defects, could be the front-runner to helm the U.S. Food and Drug Administration (FDA) in the administration of Donald Trump.
Srinivasan, who is a close associate with venture capitalist and Trump transition team scientific adviser Peter Thiel, has been a critic of the FDA. Srinivasan met with Trump on Jan. 12, allegedly about the FDA positions, according to Bloomberg.
Srinivasan was known for using his Twitter account to criticize the agency for slow approval of new medications. In a tweet, Srinivasan has said that “before the FDA, scientists were able to take insulin from bench to bedside in two years.” He also said that “for every thalidomide though, many dead from slow approvals.” Thalidomide was initially prescribed as a sedative, but many women taking the drug during pregnancy delivered children with phocomelia (malformation of the limbs). Only about half of those children survived.
In addition to criticizing the FDA for slow approval of medications, Srinivasan has also used his social media platform to suggest disbanding the FDA and use an online ratings tool like Yelp to show which drugs are most effective. In 2013, Bloomberg reported that Srinivasan proposed the idea of “a world run by software that could circumvent regulation.”
After the Jan. 12 meeting with Trump, Srinivasan has allegedly become the front-runner for the FDA top spot, bypassing another Thiel associate, Jim O’Neill, who met with Trump in December. O’Neill currently serves as a managing director of Thiel’s Mithril Capital Management. He has had government experience, most recently serving as principal associate deputy secretary at the Department of Health and Human Services in the administration of President George W. Bush. O’Neill has also called for reforming the FDA. In a 2014 speech at Rejuvenation Biotechnology, O’Neill said the FDA should be reformed to allow for the approval of drugs “after their sponsors have demonstrated safety—and let people start using them, at their own risk, but not much risk of safety,” Bloomberg reported. O’Neill also argued for a free-market approach to medication. In 2009, he said that kind of approach would drive drug prices lower and “allow innovation in cheaper delivery of care, both in terms of drugs and devices and better forms of delivery,” according to Bloomberg.
Neither O’Neill nor Srinivasan have significant medical or scientific background, which would fit into the idea that Trump hopes to disrupt the FDA. While on the campaign Trail, Trump called the agency the “Food police,” regarding regulations placed on farmers and food inspections. But Trump has also called for more efficiency at the FDA when it comes to approving new drugs. In his 100 Day Plan, Trump said one FDA-specific reform he intends to undertake is to “cut the red tape at the FDA.” According to Trump’s plan, there are “over 4,000 drugs awaiting approval, and we especially want to speed the approval of life-saving medications.” Trump has also called for easing restrictions for drugs that have been approved by foreign regulatory agencies to be available in the United States, which would bypass the FDA’s regulatory authority over drugs available in the U.S.
Since his meeting with Trump, Srinivasan has deleted all but one of his tweets, Gizmodo reported this morning. Some suggest that he deleted his Tweets to minimize any controversies, but the Tweets have been captured by a number of news agencies and sites.
