Scott Gottlieb may be gone from the Food and Drug Administration, but his successor plans to continue the work he started.
In his first all-hands meeting speech at the FDA, acting Commissioner Ned Sharpless pledged to continue efforts to use the agency’s generics and biosimilars programs to increase market competition and reign in prescription drug costs. With respect to efforts to combat dubious and unproven products like those offered by some stem cell clinics, he drew on his own experience as an oncologist and former director of the National Cancer Institute. “Personally, as an oncologist, I have seen first-hand how charlatans will sell false hope to prey on desperate patients with cancer and other diseases,” he said in the speech. “It’s important we stand up for the consumer and expose fraudulent products, particularly those pitched to vulnerable populations.”
The return of outbreaks of vaccine-preventable illnesses like measles, thanks to growing opposition to vaccines against them, is also the subject of work that Sharpless said the agency will keep carrying out under his watch, particularly by communicating about the safety and effectiveness of vaccines. “Any physician my age is horrified to see these outbreaks of measles, a life-threatening infection that we thought we had licked, but is now making a tragic comeback because of vaccine avoidance,” he said.
On a more positive note, he said he was eager to support the work on novel biologic products, such as cell and gene therapies. Gottlieb’s tenure saw the first-ever approvals of cell therapies in 2017 – namely Novartis’s Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel), from Kite Pharma, now part of Gilead Sciences. Luxturna (voretigene neparvovec), from Spark Therapeutics – recently acquired by Roche – subsequently became the first-ever approved gene therapy later that year.
Sharpless was named as acting FDA commissioner last month following the surprise March 5 resignation of Scott Gottlieb, who had previously denied rumors that he would resign. Earlier this month, Gottlieb returned to his previous employer, the American Enterprise Institute, a conservative think tank, to focus on drug pricing and the “market failures” that lead to high drug costs.
Photo: Food and Drug Administration, Flickr (free of all copyright restrictions and available for use and redistribution without permission)
