乌鸦传媒

President Biden's nominee for FDA commissioner, Robert Califf, MD, fielded pointed questions about a variety of controversial topics during a on Health, Education, Labor and Pensions on Tuesday.

Questions ranged from the agency's approval of Oxycontin to risk mitigation protocols for mifepristone (Mifeprex), as well as his close ties to the pharmaceutical industry.

In his opening statement, Califf said that his top priority, should he be confirmed, is to focus on emergency preparedness and response -- learning from what the pandemic has taught the country so far and applying those lessons.

Other priorities include ensuring the safety of the food and drug supply, curbing the opioid epidemic, developing a "systematic approach" to evidence generation, protecting children from tobacco products, and "attracting and retaining" the agency's scientific workforce.

Califf is the head of clinical and policy strategy for Verily Life Sciences, and was a professor of cardiology at the Duke University School of Medicine. He was previously FDA commissioner from February 2016 to January 2017, confirmed by the Senate in a vote of 89-4.

The committee's leaders on both sides of the aisle praised his experience and fitness for the role.

Sen. Patty Murray (D-Wash.) noted that families trust the FDA to ensure the foods they eat are safe and that the prescriptions they receive help rather than harm them. The agency needs a strong hand to address public health emergencies like the COVID-19 pandemic and the opioid crisis, she said.

"Families also deserve to know they have an experienced leader at the FDA who understands the many challenges our nation is facing and the importance of ensuring science comes first," Murray added.

When he last led the agency in 2016-2017, Califf was confirmed with strong bipartisan support, she noted.

Ranking Member Richard Burr (R-N.C.) hailed Califf as a "wonderful father, grandfather, great doctor and great man ... I'm not sure you could write a resume of somebody more qualified to be considered for commissioner of the FDA than Rob Califf."

While underscoring the "historic progress" the agency has made over the last 2 years, swiftly and safely authorizing three COVID vaccines and more than 420 COVID tests, Burr also stressed that "the next commissioner cannot take their foot off the gas."

FDA's Role in the Opioid Crisis

In response to questions from Murray, Califf outlined the steps he plans to take to help address the opioid epidemic, such as expanding efforts around prescriber education, "crack[ing] down" on people who use opioids inappropriately or those who prescribe them inappropriately, and strengthening efforts to develop alternative medications and behavioral health therapies for pain.

But Sen. Maggie Hassan (D-N.H.) was more interested in what she viewed as a "troubling" lack of any acknowledgement by FDA officials about their own role in exacerbating the opioid epidemic through "mistakes" in regulating Oxycontin.

Given that many people with substance use disorders first became addicted to opioids through legal prescriptions for Oxycontin, Hassan asked whether the FDA's initial approval of the drug and its 2001 decision to expand its indication to include the treatment of chronic pain were mistakes.

Califf said that, in hindsight, approving a drug without any long-term studies or assessment of its addictive potential "is something that could have been done differently." With regard to expanding the drug's indication to include long-term use for chronic pain, Califf again said that long-term studies should have been required before permitting use of the drug for long periods.

"Why didn't you take action to change the Oxycontin label when you led the FDA in 2016?" Hassan asked.

He did take certain measures, Califf said, including supporting the long-term studies that were needed to collect evidence about long-term use, and contracting with the National Academy of Medicine to overhaul the protocol for opioid evaluation.

Usually, the risk-benefit calculus focuses solely on the individual to whom a drug is prescribed, but opioids impact "many other people in society," Califf noted, arguing that the change to the evaluation process was "successfully done."

However, Hassan pointed out that Califf, in his opening remarks, mentioned a family member who had been given a 30-day prescription for opioids after a minor surgery and asked if there's a reason the FDA should not be "aggressively ... pursuing relabeling."

As more evidence is collected, "we are going to need to aggressively look at relabeling," Califf replied.

Hassan, citing the hundreds of thousands of deaths from overdoses, strongly disagreed: "There is plenty of evidence about what we need to do about this epidemic and the FDA needs to take the lead."

Later in the hearing, Califf acknowledged that he had "certainly made a number of mistakes," adding that coordination among agencies is "more human and complicated than you would think on the outside."

Mifepristone Restrictions

The risk evaluation and mitigation strategy (REMS) for the abortion drug mifepristone was another flashpoint at the hearing, with Republican senators arguing that the REMS protocol should not be relaxed.

Sen. Mike Braun (R-Ind.) said the FDA "weakened" the REMS for mifepristone under Califf's watch in 2016 and asked whether that "relaxed kind of interpretation" of the procedure was something he planned to pursue.

In April, the FDA unveiled a policy of "enforcement discretion" around the in-person dispensing of mifepristone, which enabled patients to receive the medication by mail. In May, the FDA around the drug.

Califf, who cited a court document regarding a review of the data on mifepristone, said a re-evaluation of the REMS for the drug is "imminent."

While he will not be involved in the process, Califf said he knows the team responsible for the review and is confident that those individuals "will be looking at the latest data and applying the best science and make the best possible decision."

Braun ended his questioning by asking permission to submit testimony, for the record, from an individual who "experienced complications resulting from a chemical abortion drug."

Murray accepted the submission and also included her own submission to the record of a recent study on the safety of mifepristone from the .

Ties to Big Pharma

Sen. Bernie Sanders (I-Vt.) raised concerns over the revolving door between the FDA and pharmaceutical industry. He flagged one person in particular, Curtis Wright, who served as a "high-ranking official." After leaving the agency in the mid-1990s, he received a $400,000 compensation package from Purdue Pharma "less than a year after [the FDA] approved Oxycontin with a label that said it was, quote, very rare, end quote, for patients to become addicted to that opioid."

Since leaving the FDA, Califf has made "several hundred thousand dollars" from pharmaceutical companies, Sanders noted, and according to his own financial disclosure statements, currently owns "up to $8 million in stock of major pharmaceutical companies."

Given these close industry ties, Sanders asked what reassurance Califf could offer Americans that he will be "an independent and strong voice" for the agency?

"I am a physician first and foremost," Califf said, citing his work in intensive care units in the early part of his career.

But Sanders persisted, calling out Califf's work as a consultant in the pharmaceutical industry. "How can the American people feel comfortable you're going to stand up to this powerful special interest?" he asked.

Califf urged Sanders to look at his track record, adding that the Biden administration's ethics pledge is "the most stringent ethics pledge in the history of administrations."

Shifting gears, Sanders asked Califf whether he believed Medicare should be allowed to negotiate prescription drug prices.

"I'm on record of being in favor of Medicare negotiating with the industry on prices," Califf responded.

Comment