Califf grilled on avian flu, drug shortages, and adcomms during Senate Appropriations hearing

US Food and Drug Administration (FDA) Commissioner Robert Califf told a Senate Appropriations subcommittee on Wednesday that he needs lawmakers’ help “filling in the holes” in the pharmaceutical supply chain to address drug shortages and outlined steps the agency is taking to address the recent avian flu outbreak in dairy cattle.

In other areas, Califf told the panel FDA plans to publish a final rule on medical gases by October 2024 and downplayed the need for the agency’s advisory committees to include voting questions on products during their meetings.

Califf said that the agency’s FY 2025 budget request seeks $7.22 billion between appropriations and user fees, an overall increase of $341 million in annual funding above the FY 2024 enacted level. He said that “we intend to take significant new steps in our approach to addressing our numerous challenges, including the largest reorganization in the history of FDA, virtually every agency in the FDA will be affected by the reorganization, affecting 8,000 of our 18,000 employees.”

Avian flu outbreak

After delivering his prepared testimony, Califf was asked to address the FDA’s response to the recent outbreak of highly pathogenic avian influenza (HPAI), which has been found to infect to dairy cows, raising questions about the safety of the US milk supply. So far, the agency has said the pasteurization process is working to inactivate the virus and that no samples of retail dairy products have been found to contain live, infectious virus.

Califf also told the panel that the virus is mutating, and that “we need to prepare for the possibility that it may jump to humans.”

Califf said that the agency is in the process of launching countermeasures to address the threat of virus spread. He said that “if we institute the countermeasures now, we are less likely to see a mutation that will jump to humans.”

He added that the agency is coordinating this work with the Department of Agriculture and the Centers for Disease Control and Prevention. At the highest level, the White House Office of Pandemic Preparedness and Response Policy (OPPR) is coordinating the overall response. He said that he is meeting daily with other agencies in reviewing and monitoring recent developments and formulating a response.

Drug shortages

Sen. John Hoeven (R-ND) asked Califf to discuss the “biggest challenges” in addressing drug shortages.

Califf said there are currently over 200 drugs in shortage. FDA’s primary activity is “hole plugging” its knowledge base in responding to drug shortages. He told the panel that “we need some help from you all in filling in the holes in our knowledge areas.”

FDA’s FY 2025 budget request includes $12.3 million to advance FDA’s capabilities to help prepare for and respond to shortages; the funding will be used to improve analytics to estimate risk of disruptions in drug manufacturing and identify vulnerabilities to enable FDA to intervene sooner. Of that, $3 million is dedicated to the recruitment of skilled investigators who will conduct inspections.

Califf said that the additional funding is a band-aid solution to a more fundamental market failure where generic drug prices are so low that CEOs are reluctant to invest much money in improving the quality of generic drugs and investing in the facilities where these drugs are made. Currently generic drugs account for 95% of all prescriptions in the US.

Opioids and advisory committee restructuring

Califf was also asked by Sen. Joe Manchin (D-WV) to address the agency’s plans for tackling the opioid crisis. Manchin said that “opioids is a scourge for society and has devastated our state in ways you can’t believe, we have killed more people with overdoses.”

Manchin said that there is a flood of opioids on the market and questioned why FDA keeps approving new opioids without removing older versions.

Califf responded that “we need a legal construct if we are going to pull things from the market.” He told Manchin, however, that he favors any legislative proposal that calls for removing older versions of these drugs from the market. He agreed that “we don’t need more opioids on the market right now.”

Manchin also questioned Califf’s about plans for advisory committee reforms and whether there are plans to eliminate voting,

For more than a year, Califf has cited the need to reform the agency’s advisory committee system following some controversial decisions in which the agency moved against the recommendation of its committees. FDA will be holding a listening session on 13 June.

“First of all, as a clinical scientist, the pinnacle of my academic career was being on the cardio and renal advisory committee, I don’t think that anyone is advocating to completely take the vote away,” Califf said.

Yet he added that “what FDA is most interested in is what is the thinking about why they feel the way they do. This is much more important than taking a vote on something in one day when FDA has been looking at the data for months.

In other areas, Sen. Cindy Hyde-Smith (R-MS) expressed concern that the FDA has not yet issued a final rule on medical gases. She noted that a proposed rule was issued in May 2022 and that FDA is long overdue in issuing a final rule. In response, Califf said that plans to publish a final rule in October 2024.

Hearing

Califf grilled on avian flu, drug shortages, and adcomms during Senate Appropriations hearing

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