December 14, 2021 – Robert M. Califf, MD, plans to carefully study federal policy on opioid prescriptions in its expected second turn in the top U.S. regulator of medical devices, as well as to more closely monitor the performance of drugs approved by accelerated approvals.
Califf on Tuesday asked questions at a Senate hearing about his nomination by President Joe Biden as FDA director), in which the role was in the Obama administration. He also spoke of the need to strengthen the nation’s ability to maintain an adequate supply of key medical products, including medicines.
Members of the Senate Committee on Health, Education, Labor, and Pensions, which deals with the Califf nomination, were mostly cordial and supportive during the hearing. Sen. Patty Murray (D-WA), chairman of the committee, and the Republican’s top Republican, Sen. Richard Burr of North Carolina, addressed Califa during the hearing as if he would soon serve as FDA leader again. Both were among the senators who voted 89-4. confirm Califfa in February 2016 vote
Califf has “previously been confirmed to lead the FDA in a large number of bipartisan votes and I look forward to working with him again to ensure the FDA continues to protect families across the country, maintain the gold standard of safety and efficiency and put science and data first,” he said. Murray.
Less enthusiastic about Califf was Senator Bernie Sanders (I-VT), who was among seven senators who did not vote on Califf’s 2016 nomination.
Sanders opposed Califf’s ties to the pharmaceutical industry in 2016 and did so again on Tuesday. A noted leader in conducting Clinical trials, Califf has worked with many drug manufacturers. But at the hearing, Califf said he agreed with Sanders about an idea strongly opposed by the pharmaceutical industry.
In response to Sanders ’question, Califf said he had already“ recorded that he was for Health Care negotiate prices with the industry. ”
The FDA will not be directly involved in the negotiations, as this work would be handled by the Centers for Medicare and Medicaid Services. Democrats want to give Medicare some negotiating powers through their comprehensive Return on Better Development Act.
People in the United States are appalled by both the price of prescription drugs and the widespread distribution of prescription pain medications that have helped fuel the current opioid epidemic, Sanders Califfu said. Many people will be concerned about the FDA commissioner who has benefited from close ties to the industry, Sanders said.
“How will they believe that you will be an independent and strong voice against this extremely powerful, special interest?” Sanders asked.
“I completely agree with you that the prices of pharmaceutical products in this country are too high,” Califf said in response.
Califfu paid $ 2.7 million in salaries and bonuses by Verily Life Sciences, a biomedical research organization run by Alphabet Inc., Google’s parent company, according to its federal financial announcement. He also reportedly holds board positions on pharmaceutical companies AmyriAD and Centessa Pharmaceuticals PLC.
The Bloomberg government reported that Califf has ties to about 16 other research organizations and biotechnology companies. The Bloomberg government also said that in its former FDA service, Califf held a whiteboard in his office listing all activities and projects that required his exemption, citing Howard Sklamberg, a deputy commissioner under Califf, as the source.
“He was very, very, very cautious,” Sklamberg, who is now a lawyer at Arnold & Porter LLP, told the Bloomberg government.
‘Work to do’ on opioids
Senators have repeatedly returned to the topic of opioids during the Califf hearing, reflecting deep concern over the FDA’s efforts to warn of the risks of prescription pain medications.
It is estimated that there were 100,306 drugs overdose deaths in the U.S. in the 12 months to April, an increase of 28.5% from 78,056 deaths in the same period a year earlier, according to CDC.
Califf said it plans to focus on information the FDA is passing on to the public about the risks of prescription pain medications, including a look at what is written on labels for those products.
“I am committed to doing a comprehensive review of opioid status, at the beginning of my term,” Califf said.
Califf noted that doctors are still giving overdoses of these drugs too quickly, despite years of efforts to curb their use. He said he knows relatives who received 30-day prescriptions for opioids after minor surgery.
“So I know we have work to do,” Califf said.
Concerns about the FDA’s previous work in opioid management have led to this to protests by several Democratic senators over the possibility of Biden nominating acting FDA Commissioner Janet Woodcock, MD, for the permanent position.
At the hearing, Senator Ben Ray Luján (D-NM) initiated a case of FDA approval of a powerful painkiller Zohydro. The agency approved the drug despite this 11-2 votes against this by the FDA’s Advisory Board on Anesthetics and Analgesics.
Luján asked Califa what he would do if the FDA’s advisory board voted “by a large majority” against the drug approval recommendation, as happened in the Zohydro case.
Although Luján did not mention him in this exchange during the hearing with Califf, the refusal of FDA staff to recommend advisory committees raises growing concerns among researchers.
Last year, the agency approved aducanumab (Aduhelm, Biogen), a drug for Alzheimer’s disease, rejecting the advice of its Advisory Committee on Medicines for the Peripheral and Central Nervous Systems. That decision prompted resignations of several council members. FDA staff also earlier rejected the conclusion of a majority of members of the same advisory board on offer in 2016 on eteplirsen (Exondys 51), a drug for Duchenne muscular dystrophy.
Califf told Luján that he had recently conducted a survey on how often FDA staff disagreed with the advisory board’s recommendations. He said the FDA is taking a different direction in about 25% of cases. In approximately three-quarters of these cases, FDA staff opted for a “stricter” approach to allowing public access to the drug, as opposed to the more generous one seen in the Zohydro, Aduhelm, and Exondys 51 cases.
Still, Califf said that when there are 11-2 votes of the advisory board against the product recommendation, “FDA leaders really need to look closely” at what is happening.
The issue of expedited approvals
FDA approval of aducanumab has attracted attention conditional approvals known as accelerated approvals are already under discussion.
The FDA has used this path since the 1990s to speed up access to medications for serious conditions. The trade-off for early access is that the agency sometimes makes the wrong call based on initial findings and cancels a drug that was later found not to benefit patients as expected.
FDA Cancer division is amid public efforts to address cases where drug manufacturers have been unable to conduct studies supporting accelerated approvals of their oncology drugs. In addition, the Office of the Inspector General of the Department of Health and Social Services announced in August that it was inspecting FDA’s handling of the accelerated approval process.
At Tuesday’s hearing, Burr asked Califa how he would respond to calls to change the way the FDA handles the accelerated approval process.
“Can you commit to me and patients who can rely on top-notch treatments that you will not support efforts to narrow this path or raise the limit for drugs that will be approved under these pathways?” Burr asked Califf.
Califf responded by saying he was “a fan of accelerated approval – for the right conditions.”
Earlier, in his opening remarks, Califf said his mother benefited directly from the accelerated approval of new drugs for multiple myeloma. Califf told Burru that he had spent “countless hours with groups of patients” and understood the need to speed up the approval of drugs for serious illnesses.
But the FDA must also make sure to maintain its part of the deal with expedited approvals. This includes checking how these medicines work after being placed on the market.
“We accept that there is more uncertainty,” Califf said. “This means we need to have a better system for evaluating these products as they are used in the market. And I think there are ways we can do that now. Technology makes it possible in ways that were not possible before. ”
Worries about the medical supply chain
Sen. Susan Collins (R-ME) asked Califa about the vulnerability of the U.S. medical system to supply chain disruptions. She expressed concern about China’s dominance in antibiotic production as an example. She asked if Congress could do more to encourage domestic production of medical supplies, such as offering tax incentives.
Califf told Collins that he shared her concerns about the U.S. production of ingredients used in the brand and generic drugs. He said he recently served on the board of the National Academy of Medicine which examines supply chain issues.
The committee will soon release a report with concrete recommendations, Califf said.
“We don’t have enough competing entities in what has become a kind of commodity business” of drug manufacturing, Califf said. “So we need a few steps to make the system more resilient.”