One of the Food and Drug Administration’s top officials said in a new video that he is not blocking drugs that are supported by evidence of safety and efficacy, responding to critics who have said he is responsible for a low number of drug approvals.
Prasad is the FDA’s chief medical and scientific officer as well as the director of the agency’s Center for Biologics Evaluation and Research, which handles applications for vaccines and certain drugs.
The Wall Street Journal opinion page has published a series of articles critical of Prasad, including an Aug. 13 piece alleging that drug approvals had “hit an FDA wall.” It said that Prasad had used “dubious safety risks” in acting against the gene therapy and that support from Dr. Marty Makary, the FDA’s commissioner, for Prasad was “creating tremendous uncertainty for pharmaceutical developers.”
Prasad, Makary, and Sanjula Jain-Nagpal, another FDA official, took turns in the new video quoting from Journal articles. They said they appreciated articles from the Journal’s news team, but that its opinion pieces contained false information, including the claim that in the first seven months of the year, the FDA Center for Drug Evaluation and Research had only approved 22 new drugs.
“The number is not correct,” Makary said. It was actually 32.
While 22 approvals would put the FDA on track for a lower than normal figure at the end of the year, 32 would put the agency on track for one of the highest figures for a year on record, he said.
Makary said the FDA alerted the Journal, but the paper refused to update the figure or issue a correction.
The Journal did not respond to a request for comment by publication time.
Prasad said in the new video that he has never advanced a campaign to block any immunotherapy. He said that the review of the data for the therapy was led by the FDA’s Oncology Center of Excellence.
“I’m flattered at the idea that I got the time to read all the files here and keep track of everything. I’m flattered at that idea,” he said. “But we have 18,000 people who are working in different groups, and different people take the lead on different things.”
Prasad added later that various FDA actions show the agency is looking to work with companies that have applied for approval for their products, including by beginning the practice of publishing complete response letters to companies that do not receive an approval.
“We try to do a good job in speeding the good drugs to market, but also a good job in helping companies that aren’t quite there yet or have unsuccessful drugs to understand what they need to do better to get across the finish line,” he said. “And it’s really both how fast we are and how responsive, and the quality of our decisions that I think is the best it’s ever been.”
