Califf Vows War on Social Media Rx Promos
FDA commissioner nominee Robert Califf says, if confirmed, “I’m going to be very aggressive in this area of medical misinformation (on social media) because one could argue that it is killing more people than any particular disease right now.” Califf’s hard line on social media promotions came in response to a question during a 12/14 Senate Health, Education, Labor & Pensions Committee confirmation hearing from Senator John Hickenlooper (D-CO) on whether FDA needs to take a more active role ensuring that there’s sufficient oversight of direct-to-consumer (DTC) advertising.
Califf strongly agreed there should be more DTC oversight. He said he and other physicians do not like that there’s advertising of drugs, “but we don't make those laws. So the FDA has to regulate it, and I think we need an across-the-board update and a much more active FDA in terms of getting the right information to the public. It's right there in the mission statement of the FDA to make an understanding of the science behind medical products and their use for the public. But it's not just advertising done on TV like we are used to seeing. There’s a huge amount of information going on social media that we're going to have to deal with....”
In his opening statement at the hearing, Califf said the current state of the agency and the U.S. is a “once-in-a-generation time for public health.” He said his priorities if confirmed would be emergency preparedness and response; consumer and patient protection; and modernization and innovation. As his first priority, he said: “FDA must continue to be a strong partner in battling Covid-19, taking into account lessons learned from the pandemic so we can apply them to the ongoing current pandemic so we are ready for the next one.”
Secondly, he said all FDA actions regarding the products the agency regulates “must focus on protecting consumers and patients. Safety matters. Now is the time to develop a systematic approach to evidence generation that will improve patient safety and provide a much more efficient way to understand the benefits and risks of medical products when used in practice and to ensure that our food is safe. And we must protect kids from tobacco products.” Califf also said rising overdoses means FDA must work with the public health, clinical and policy committees to turn the tide.
Thirdly, Califf said FDA must stay current on the latest advances in science and technology “in order to provide guidance to industry and stakeholders on everything from clinical trial conduct to regenerative medicine, to best practices for protecting the safety of the U.S. food supply.
Califf noted that as he works to implement the priorities, attracting and retaining FDA scientific workforce may be even more important than any particular policy “because it is the agency's day-to-day decision making that protects the public.” He said FDA must continue to play a vital role in protecting and promoting public health by leveraging the acceleration of technology and biomedical knowledge.
Asked by committee chair Patty Murray (D-WA) what can be done to improve Covid diagnostic testing in the U.S., Califf said it is complicated but generally speaking FDA and developers need to understand the operating characteristics of tests and the underlying technology. “We really need to redouble our efforts now with Omicron variant on [testing] because we know it has a much higher rate of reinfection in people who have already been infected, or breakthrough infections in people that are vaccinated,” he said. Fundamentally, Califf said the U.S. has got to work together to make the tests available so that they're not expensive, and every family should have a quantity of tests that they can use as needed.
Asked by senator Richard Burr (R-NC) for assurances that FDA’s accelerated approval system will not be watered down due to recent criticisms in the wake of Biogen’s approved Alzheimer’s drug Aduhelm (aducanumab), Califf said he was a “fan of accelerated approval for the right conditions... Accelerated pathway means that we’re accepting that there's more uncertainty, and the FDA has tremendous latitude about the decision it makes with those pathways. That means we got to have a better system to evaluate these products as they're used on the market, and I think there are ways that we can do that now. Technology is making this possible in a way that just wasn't possible before.”
Senator Bernie Sanders (I-VT) questioned Califf directly on his ties to the pharmaceutical industry, noting that his financial disclosure form shows up to $8 million in stock ownership in major pharmaceutical companies. “At a time when the American people are outraged by the high cost of prescription drugs, and deeply disturbed about what happened with Purdue and Oxycontin, what kind of comfort can you give to the American people when you have been so closely tied to the pharmaceutical industry yourself?” Sanders asked. “How are they going to believe that you’re going to be an independent and strong voice against this enormously powerful special interest?”
Califf agreed that the price of pharmaceuticals is “way too high” in this country, and he has been on record supporting Medicare’s future authority to negotiate drug prices. He said he has a history of standing up to industry, and he also pointed out that the Biden administration has the most stringent ethics pledge in the history of administrations. “They reviewed my status and I've agreed to the ethics pledge, and FDA and HHS have excellent staff whose job it is to make sure that those ethics pledges are satisfied.”
Before the hearing, senator Joe Manchin (D-WV) reaffirmed his earlier opposition to Califf. “I can’t fathom why we would confirm someone whose actions failed to swiftly curb the tide of the opioid epidemic and protect the public’s health, especially someone who has already helmed FDA as its commissioner,” Manchin said in a statement. “Furthermore, Dr. Califf has indicated he plans to keep Dr. Janet Woodcock, who has led the FDA and directly overseen the approval of numerous highly addictive drugs to market, as part of FDA leadership.”
After the hearing, senator Bernie Sanders (I-VT) said he was also opposing Califf’s nomination because of his close ties to the pharmaceutical industry. But throwing their support behind the nomination in a letter released Monday are six former commissioners who said “the absence of a confirmed commissioner complicates the agency’s ability to undertake and sustain the leadership needed now to protect and promote the health of all Americans.” It was signed by Andrew C. von Eschenbach, Scott Gottlieb, Stephen Hahn, Margaret A. Hamburg, Jane E. Henney and Mark McClellan.