As President Trump weighs nominees to head the FDA who mostly agree that the agency’s approval process must be accelerated, the head of the pharmaceutical industry’s most powerful lobbying group responded, in effect: Now hold on there, Mr. President!
As STAT reports, Stephen Ubl, the CEO of the Pharmaceutical Research and Manufacturers of America, insisted to reporters that, “We believe that the FDA review process is the gold standard and should remain so.” The press conference is part of the industry’s Go Boldly campaign to improve its public image. Drug prices are soaring and manufacturers are often blamed. Go Boldly, but be tactful, because Ubl would not comment on the two men who are considered to be in the lead for the FDA’s top spot.
But both of those candidates—Jim O’Neill, a Silicon Valley libertarian, and Joseph Gulfo, MD, the author of Innovation Breakdown: How the FDA and Wall Street Cripple Medical Advances (need we say more?)—want to limit the FDA’s influence. O’Neill wants to be able to put drugs on the market without first evaluating whether or not they actually work. Gulfo wants to scale back the requirements for approval.