Dr. Joseph Gulfo confirmed that he has spoken with the administration of US President Donald Trump regarding him being named FDA Commissioner. Gulfo has outlined his views on how the FDA should approve drugs and work on lowering the prices. Gulfo stated that the FDA forces companies to prove that their products measurably improve patient outcomes and delaying approvals thus increasing the drug prices.
Gulfo gave the example of cholesterol lowering drugs Praluent and Repatha. He stated that although the drugs lowered LDL cholesterol in clinical studies, the indications were limited by the agency pending the outcomes of long-term cardiovascular trials of the drugs. According to Gulfo, he recommends a four-tier system of approving drugs. This ranges from the lowest level of evidence of affecting a biomarker to the highest level at which there are confirmed life-prolonging effects.
Last year the FDA approved Sarepta Therapeutics’ Exondys 51, a Duchenne muscular dystrophy drug. This gave patients greater leeway in judging the risk-benefit ratio. The critics of the relaxed rules contend that there is no evidence that the drug companies will lower drug prices once restrictions on drug approvals will be eased up by the agency according to a report by FirstWord Pharma.
Gulfo has held senior roles at a number of biopharma companies in the past. Gulfo is a medical doctor and an M.B.A. and is currently the executive director of Lewis Center for Healthcare Innovation and Technology. Although Gulfo has not commented publicly on his candidacy, he made it clear recently that he would be interested serving the Trump Administration as the FDA chief. He said that he would be honored to serve President Trump and bring real reform to the FDA.
Dr. Joseph Gulfo has been an outspoken critic of the FDA and has penned a manifesto for its reform. Gulfo joints a list of possible candidates to head the agency. The list also includes tech capitalist Jim O’Neill, Balaji Srinivasan, a specialist in computational biology and Scott Gottlieb, a former FDA staffer and a partner at venture capital fund New Enterprise Associates as reported in an article by FierceBiotech.