President Trump as nominating Dr. Scott Gottlieb to be Commissioner of the Food and Drug Administration (FDA). Gottlieb is a medical doctor and former FDA deputy commissioner.
Gottlieb has advocated speeding up the approval complex generics — cheaper, copycat versions of products such as Mylan’s allergy jab, the EpiPen, and Copaxone, an injection for multiple sclerosis from Teva, which both command high prices.
Dr Gottlieb is a cancer survivor who survived cancer.
He advocates patient power and backs several reforms that would make it easier for some drugs to secure approval.
More medicines could be designated as “breakthrough” treatments to get faster approval.
He supports the conditional or “accelerated” approval of medicines based on early evidence gathered during smaller clinical trials, rather than waiting for the conclusion of longer studies that provide more definitive proof.
Gottlieb would bring a strong pro-industry, deregulatory approach to an agency that Trump has criticized as being overly restrictive. But he is also likely to support one of the agency’s basic functions: to ensure that drugs are proven safe and effective before they are sold.
His selection is a victory for the mainstream pharmaceutical industry, which has little appetite for upending the FDA approval process. Even many Democratic critics of the drug industry, and of Gottlieb himself, privately indicated they strongly preferred him to another frequently mentioned contender, Jim O’Neill, an associate of Silicon Valley billionaire and Trump adviser Peter Thiel. In a 2014 speech, O’Neill called for allowing drugs to be marketed after they were proven safe, but before they were shown to be effective.