CALIFF GETS HIS DAY ON THE HILL — Califf will face the Senate Health, Education, Labor and Pensions Committee today to make his case for returning to FDA as its chief nearly five years after his last stint. With the pandemic entering its third year and the Biden administration its second, getting a commissioner confirmed will be a top priority for the Senate in January. Califf generally has support from the public health community and former FDA officials. On Monday, six former FDA commissioners endorsed Califf's candidacy in a letter to the Senate HELP Committee that he is "deeply committed to public service, to advancing science and clinical evidence, to effective and transparent communication and to strengthening and modernizing FDA." Still, as we’ve previously reported, that doesn’t mean Califf’s confirmation process will be smooth sailing, as some Dems have already registered opposition to the cardiologist over his extensive industry ties. But that resistance is unlikely to keep him from winning enough support, considering he’s already been confirmed once before by the Senate and the White House went so long without even nominating a candidate. Here are the issues your RxP scribes will be focusing on during the hearing: Pandemic response: FDA will continue to be the lead arbiter in whether Covid-19 vaccines, therapeutics and tests get authorized and eventually approved. The emergence of the Omicron variant raises questions of how the agency will balance using existing tools to target that strain with advancing new technologies and treatments for Covid. Opioid crisis: Several Democrats have raised concerns about FDA’s role in the opioid crisis, raising the possibility Califf will need to garner support from Republicans to receive a favorable vote from the HELP Committee. Sen. Joe Manchin (D-W.Va.) is already signaling he will vote against Califf if his nomination reaches the Senate floor. “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. “More than 500,000 Americans have died since the FDA first approved Oxycontin in 1995.” Accelerated approval pathways: Califf was FDA commissioner when the agency cleared Spinraza, a highly contentious drug for Duchenne muscular dystrophy, via its accelerated approval pathway. This summer, the agency’s accelerated approval of Aduhelm, a drug for Alzheimer’s disease, sparked an even more voracious debate around the pathway, which allows a drug to be marketed if it improves a surrogate endpoint instead of patients’ health or quality of life. Outcry after Aduhelm’s approval triggered a probe by federal officials into the process, which some experts believe was long overdue. “In terms of accelerated approval, we’ve been very concerned,” Diana Zuckerman, the president of the National Center for Health Research, a nonprofit think tank based in D.C. “The question for Califf would be, ‘What do you think of this decision, how would you have handled it differently, how will you handle it [now]?’” Without an overhaul of the accelerated approval process, Zuckerman fears that other therapies with little to no evidence of a clinical benefit will hit the market to the detriment of patients. Tobacco regulation: FDA’s Center for Tobacco Products finds itself at a pivotal moment as it faces multiple lawsuits over its regulation (or lack thereof) of certain tobacco products, including e-cigarettes and menthol cigarettes. The stakes are even higher now that Mitch Zeller, CTP’s director for the last seven years, will be retiring in April 2022 . Both industry leaders and public health officials have expressed hope that Califf will provide CTP with a clear direction. Industry ties: Califf’s financial disclosures show he made more than $2.7 million in the past year as a senior adviser to Alphabet-owned Verily Life Sciences, plus more than $77,000 in compensation for serving on two pharmaceutical companies’ boards and numerous stock options. Expect Dems like Sen. Ed Markey (D-Mass.) to seize on this. From the dais: Committee Chair Patty Murray (D-Wash.) is also expected to bring up diversity in clinical trials, FDA’s role in keeping drug costs from ballooning and the upcoming reauthorization of the agency’s user fee agreements with industry, according to an aide. Meanwhile, a Republican HELP Committee aide told POLITICO that Ranking Member Richard Burr (R-N.C.) plans to highlight the importance of quickly bringing new technologies, therapeutics treatment and cures to market. WYDEN URGES HHS TO HOLD OFF ON PART B PREMIUM INCREASE — Sen. Ron Wyden (D-Ore.), the Senate Finance chair, sent a letter to the HHS secretary expressing concern over the planned premium increase for Medicare Part B attributed to potential spending on a controversial new Alzheimer’s drug, POLITICO’s Tucker Doherty reports. HHS currently plans to raise Part B premiums by $21.60 a month, of which $11 is attributed to uncertain spending on Aduhelm and similar drugs in the future. The Democratic senator urged the department to hold off on the increase pending a potential decision by Medicare to limit which patients will have access to the drug. “What is at stake here is whether we’re going to have a policy in this country where every time a big pharmaceutical company comes in and proposes an astronomical rate hike, they’re going to be able to get what amounts to a surcharge on Medicare,” Wyden told POLITICO. | 
