An increasing number of senators are threatening to block Dr. Robert Califf’s nomination to be the next Commissioner of the U.S. Food and Drug Administration. The story illustrates an unusual coalition of right and left-leaning members of the Senate, and common refrains about “industry ties” in government and medicine. Ultimately, arcane Senate rules allow the entire process to be stalled by these individual members of the body.
The U.S. Senate: Where things go to die (slowly)
Members threatening to block Califf’s nomination include Senator Joe Manchin of West Virginia. He cited Califf’s ties to the pharmaceutical industry and concerns over opioid abuse. He is joined by “Democratic Socialist” Bernie Sanders of Vermont. Presidential ambitions likely play some role in his decision to place a hold on Califf—a procedure that prevents the nomination from even coming to the Senate floor in the first place—and Sanders cites industry ties, along with Manchin.
The theatrics on the Senate floor could possibly include Manchin reading letters from West Virginia families dealing with opioid abuse, if the nomination ever gets past the hold stage. Senator Edward Markey of Massachusetts, also cites opioid concerns, along with Senator Ayotte of New Hampshire.
Not to be out done, Senator Murkowski of Alaska, a Republican, says she will hold up the vote unless the FDA changes its position on the voluntary labeling of genetically modified fish.
Califf helped establish Duke University’s clinical research center and has acknowledged that his studies have received funding from pharmaceutical companies. But he insists that they had no ability to change or hide the results, and the Senate Health, Education, Labor and Pensions Committee approved his nomination with no dissenting votes earlier this year.
In Califf’s corner against the unlikely alliance of diverse interests stands, President Obama.
“Obviously, the president and the administration have full confidence in the ability of our nominee to make the kinds of decisions that are in the best interest of the health and safety of the American people,” White House press secretary Josh Earnest recently said at a briefing. “The president would not have nominated him to the job if he didn’t think that he would be able to effectively look out for the interests of middle-class families in that role.”
According to Senate rules, one senator is allowed to block a nomination vote unless 60 Senators vote to overrule the hold. And while it is not likely Califf’s nomination will be held up indefinitely, the efforts of the senators to block Califf from moving forward highlight lawmakers’ concerns over the approvals process at the FDA.
Positives of industry ties
A recent Medscape article addresses Califf’s ties to industry and the Senate procedural hurdles facing the nominee. Although the industry ties are cited by politicians as a negative, a number of clinicians and medical professionals disagree. In the article, Medscape notes that a large group of doctors and organizations have publicly declared their approval of Califf as FDA commissioner, including the American College of Cardiology (ACC), the American Heart Association (AHA), and the American Psychiatric Association. The American College of Cardiology’s president, Dr. Kim Williams, cited Califf’s vast knowledge as a cardiologist and investigator which will be beneficial when dealing with a variety of conditions.
Dr. Jeffrey Drazen, editor of the New England Journal of Medicine stated that Califf’s interactions with pharmaceutical companies is a strength instead of a weakness because Califf will be able to illustrate the intricacies of the relationships.
“The ability to know how the pharmaceutical industry works is probably key for a person in the position of an FDA commissioner or leader. You need someone who knows the issues . . . and can give some guidance,” Dr. Williams said in the Medscape article.
It was further reported that the AHA’s CEO, Nancy Brown, stood by her organization’s support of Califf as she “cannot think of a better person” to lead the FDA, despite his ties to industry. This work, she notes, has been focused on clinical research and innovation—ultimately a positive for patients.
Many of the senators opposing Califf implicitly call into question his ability to act ethically having “ties” to industry. This is a foolish argument, at best, as noted by Dr. Robert Harrington, one of Califf’s former colleagues at Duke who cited Califf’s “highest level of integrity and honesty,” according to Medscape. “He believes passionately in providing evidence for people to practice medicine. And he has been unfailing in his quest for the truth about what works and doesn’t in a clinical setting.”
Dr. Harrington’s defense continues and serves as an important reminder of the positive outcomes from industry-physician collaboration: “I can’t imagine there’s someone who better understands the complexities of the issues, especially around the healthcare side of the FDA.” Harrington added that many of the concerns brought up by the senators revolve around politics “and don’t actually speak to his qualifications or suitability for the job.”
And regarding talk about too-close pharma ties, “the reality, from a research perspective in cardiovascular medicine, is that to understand therapeutics, then one is almost certainly going to be doing collaborative research with industry,” he said. Califf “does have a lot of relationships with industry. But they’ve always been appropriately managed and been very strict about their independence.”
Medscape’s article continues with a quote from AHA chief science officer Dr. Rose Marie Robertson, noting that Califf’s experience over the years “gives him a broad view not only of the science of the drugs and devices used in his trials, but lets him understand and be critical of study design in a way that people who haven’t had that experience would find very difficult to do.”
FDA Changes Course
One of the objections to Dr. Califf’s nomination is around the approval of opioids. Califf and others at the FDA recently called for a far reaching plan to reassess the agency’s approach to opioid medications. The plan will focus on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief. Including requiring an advisory committee for the approval of new opioids, additional warnings to immediate release labeling, and updating REMS.
Tide is moving against Hold
Recent editorials seem to suggest there is a growing interest in seeing an up-or-down vote on Califf—one he would surely win. In an editorial, several papers wrote:
Senators are entitled to object to White House nominees, but Ms. Murkowski and Mr. Markey have gone further and placed a hold on the appointment. A hold is a maneuver permitted by Senate rules that allows a single lawmaker to block a measure from receiving a floor vote.
It is often used as a partisan weapon, in which a senator from one party can hold hostage the appointment of a president from the other party. Last month, no fewer than 28 Obama nominees — for judgeships, ambassador posts, terrorism finance specialist, and high-level state department positions — were on ice in the Republican-led Senate, some of them via individual holds.
The holds on this nomination aren’t partisan payback, but they’re just as insidious because they deny the full Senate a chance to vote.