Photo courtesy of Wikimedia Commons.
The Senate’s vetting of a proposed Food and Drug Administration (FDA) commissioner may provide an opportunity for reporters to dig into some of the most pressing concerns in U.S. health policy, including the opioid epidemic and the standards used to clear new medical treatments for the market.
President Joe Biden on Nov. 12 announced his plan to nominate Robert Califf as FDA commissioner. Califf served in this same post in the final months of the Obama administration, from February 2016 to January 2017 (Learn everything you need to know about Califf in this blog post.) The next step will be a hearing on the nomination before the Senate Health, Education, Labor and Pensions (HELP) Committee. The committee expects to receive a formal nomination for Califf this week and will schedule a hearing “as soon as possible,” a HELP aide told AHCJ.
Califf likely will face questions during his next round of Senate vetting on some of the same topics he faced on the first round, including FDA’s decisions on food safety and the pace at which it approves generic drugs. Senators will likely ask him to weigh in on controversies that have emerged since, particularly the FDA’s approval of Biogen’s Aduhelm drug for Alzheimer’s disease. (The AHCJ has covered this issue in June and July blogs.)
If confirmed, Califf would also lead the FDA during the next big push in Congress to change how the agency handles drug approvals in general.
There’s a 2022 deadline for Congress to enact the next law requiring pharmaceutical companies to pay fees tied to applications for approval of their medicines. Previous enactment and renewal of Prescription Drug User Fee Act (PDUFA) laws already have meant major changes in how the agency approaches the approval process, as detailed in this 2020 FDA staff presentation. (The FDA also posted links to presentations made at this meeting by pharmaceutical industry associations and watchdog groups. These organizations are readying for a legislative battle next year on federal law on drug approvals. The FDA has posted more information on the next PDUFA renewal on this website as well. )
In this blog post, we will show you some of the sources in congressional records that may be helpful in covering the Califf nomination process and many other problems in health care.
How to cover Califf’s return nomination
Robert Califf (Photo by Mark J. Ermarth via Flickr))
Journalists can look at what happened during Califf’s previous confirmation process to prepare to cover his return nomination. The Senate HELP Committee posts recorded webcasts of its past meetings online, with the November 2015 hearing on the first Califf nomination for the FDA top job available here.
The U.S. Government Publishing Office’s GovInfo.com website also has transcripts of many hearings, including this same one for the 2015 Senate HELP nomination hearing on Califf. (There’s also a search tool on the GovInfo.com website that can be used to find past congressional hearings on different topics.)
At the Senate HELP Committee’s November 2015 nomination hearing, for example, Califf fielded questions about drug prices, an issue on which the FDA has no authority.
“People are dying, people are not buying the food they need because they have to pay outrageous prices for medicine,” Sen. Bernie Sanders (I-VT) told Califf. “We have been extraordinarily weak in taking on the pharmaceutical industry that is ripping off the American people.”
Sanders said the United States needs an FDA commissioner “who is going to stand up to the pharmaceutical industry and protect American consumers.”
“I’m going to have to say to you, with regret, that I think you are not that person,” Sanders told Califf.
Sanders was among the seven senators who did not participate in the vote on Califf’s first nomination to lead the FDA. The Senate confirmed Califf, 89-4, with Sen. Joe Manchin III (D-WV) having led the opposition to him. Manchin objected to the FDA’s approach to managing the risks of opioids over the years, with his state of West Virginia having been hit hard by the consequences of the wide use of prescription painkillers. He has argued for the nomination of an FDA leader who is less connected to drugmakers.
(Manchin does have his own tie to this industry. His daughter Heather Bresch previously served as chief executive of Mylan, a company that had sold prescription fentanyl. The National Republican Senatorial Committee raised this point as part of an unsuccessful attempt to make Manchin lose his Senate seat.)
“I have made it abundantly clear that correcting the culture at the FDA is critical to changing the tide of the opioid epidemic,” Manchin said in a Nov. 12 statement about Biden’s pick. “Instead, Dr. Califf’s nomination and his significant ties to the pharmaceutical industry take us backward.”
Despite Manchin’s objections, Califf’s second nomination as FDA chief quickly drew the support of other Democrats.
The House of Representatives does not take part in the confirmation process, but the chairman of its Energy and Commerce Committee, which has jurisdiction over the FDA, praised Biden’s pick. “Dr. Califf is a proven leader who will bring a wealth of knowledge and expertise upon his return to the agency,” Energy and Commerce Chairman Frank Pallone Jr. (D-NJ) said in a statement.
In a statement emailed to reporters on Nov. 12 about Biden’s pick to lead FDA, Sen. Patty Murray (D-WA), the chair of the HELP Committee, highlighted the previous “strong bipartisan vote,” 89-4, to confirm Califf in 2016.
“I look forward to working with him to see our nation through this pandemic and to tackle other critical challenges like the ongoing opioid crisis, rising youth tobacco use, high drug prices, health inequities and more,” Murray said, who was among the Democrats who defended Califf in public speeches on the Senate floor in February 2016.
Arguments against Califf
Manchin, Sen. Richard Blumenthal (D-CT) and Sen. Edward Markey (D-MA) made their arguments against Califf, calling for the selection of an FDA commissioner who did not have strong ties to drugmakers. (These speeches were turned up by a simple search of “Califf FDA nomination” on the website for the Congressional Record, which reports speeches given on the House and Senate floors.)
“A new FDA head must indicate there will be a sea change — a fundamental overhaul in the way FDA oversees and protects the American people,” Blumenthal said.
In Murray’s view, though, Califf showed he could work closely but independently with drugmakers.
“Our review of his record demonstrates a longstanding commitment to transparency in relationships with industry and working to ensure academic integrity,” Murray said on the Senate floor.
At the Nov. 2015 confirmation hearing, Murray had pressed Califf on this point.
“During your past clinical trial and consulting work you’ve done, how have you ensured industry views have not biased your work, and what do you plan to do to ensure you are able to lead the FDA without any undue influence?” Murray asked Califf.
Califf’s response included his longstanding commitment to transparency about the results of clinical trials. Drugmakers fund studies because they need to have their products evaluated, he replied.
“We have an independent voice, guaranteed by contract,” Califf said at the hearing. “I believe you’ll find that 100% of the studies that I’ve been involved in have been published so that they’re in the public record for people to view.”
Sen. Elizabeth Warren (D-MA) also grilled Califf at that hearing about his work on behalf of drugmakers.
The posted transcripts of Senate hearings can offer reporters additional insights, as they often contain more extensive responses offered by witnesses and sometimes lawmakers. In a statement included in the transcript of HELP’s hearing on Califf’s nomination, for example, Warren noted that he wrote additional replies to questions she posed at the HELP meeting. Warren said she also had consulted with “several outside experts in these matters to better understand the materials” Califf provided for her. This work allowed Warren to back Califf in 2016 as FDA commissioner.
But Warren added that she was “particularly concerned with a lack of overall transparency, numerous opportunities for conflicts of interest, and a marked shortage of trials that are designed to determine which products to treat a given condition are the most effective — as well as cost-effective — for various patient populations.”
“My examination has also raised concerns about the FDA’s willingness to stand up to industry preferences in the design and conduct of clinical trials,” said Warren in the statement included as part of the HELP hearing records.
Other AHCJ resources for covering the FDA