Martin Shkreli, widely known as the "Pharma Bro" and currently banned for life from the pharmaceutical industry, has taken to social media to criticize the U.S. Food and Drug Administration (FDA). In a recent tweet, Shkreli claimed that a drug for "advanced (some would say UNSTOPPABLE) melanoma should have been approved," adding that "the new FDA is a bit screwy, to put it mildly!!!" He emphasized the importance of such a drug for affected families.
Shkreli gained notoriety in 2015 as the CEO of Turing Pharmaceuticals when he drastically increased the price of the life-saving antiparasitic drug Daraprim by over 5,000 percent. His actions sparked widespread outrage and became a symbol of pharmaceutical price gouging. He was later convicted of securities fraud in 2017 and served over four years in prison. In January 2022, a federal court permanently barred him from the pharmaceutical industry, ordering him to pay $64.6 million in disgorgement.
Despite his ban, Shkreli continues to comment on the biopharmaceutical landscape. His recent tweet, however, does not specify which melanoma drug he believes the FDA wrongly withheld approval for. The FDA maintains a rigorous approval process designed to ensure the safety and efficacy of new treatments before they reach patients.
In contrast to Shkreli's assertion, the FDA has recently made significant approvals in the melanoma treatment space. For instance, in February 2024, the agency granted accelerated approval to Amtagvi (lifileucel), the first cellular therapy for adult patients with unresectable or metastatic melanoma who have been previously treated. This approval underscores the FDA's ongoing efforts to bring innovative therapies to patients battling advanced forms of the disease.
Shkreli's broad criticism of the "new FDA" without identifying a specific unapproved drug leaves the basis of his claim unclear. His past history of controversial statements and actions within the pharmaceutical industry often places his commentary under scrutiny, especially when discussing drug access and regulatory decisions.