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Opioid Pledge to Prove Tricky for FDA Head Dogged by Pharma Ties

Feb. 28, 2022, 10:35 AM

FDA actions to fight the opioid crisis will face heightened scrutiny with Robert Califf at the helm of the agency as the new commissioner strives to overcome lingering concerns over his former industry ties.

Califf has committed to leading a “comprehensive review” of opioid regulations early in his tenure, which he said would include assessing the agency’s labeling process and whether warnings accurately describe the safety risks. To be effective, though, the agency will have to ensure outside influence doesn’t get in the way.

The new commissioner “needs to bend over backwards and show that he’s on the side of the consumer, and not on the side of industry,” said Lawrence Gostin, director of the O’Neill Institute for National and Global Health Law at Georgetown University.

The Senate voted 50-46 to confirm Califf, a much smaller margin of victory than when he was first confirmed to lead the Food and Drug Administration in 2016. He overcame a fierce bipartisan blockade during his nomination hearings, with Sens. Margaret Hassan (D-N.H.), Joe Manchin (D-W.Va.), and other lawmakers raising doubts he would strengthen opioid safety rules.

But health specialists say Califf’s FDA stands to play a crucial role in curbing U.S. addiction deaths, which were estimated at around 100,000 in the year leading up to September 2021, according to federal data. Tightening restrictions on drug advertising and enhancing post-approval oversight are among the tools at the FDA’s disposal.

Califf will have to navigate how to best respond to America’s addiction crisis while staving off criticisms over past opioid actions under his watch, as well as concerns that his ties to pharmaceutical companies could stymie the effort. The commissioner made millions of dollars from health and drug companies since his last stint in government.

Former acting commissioner Janet Woodcock, who is staying at the FDA as principal deputy commissioner, could also present a challenge to agency efforts, some policy analysts say, as she oversaw the approval of several addictive opioid drugs while leading the Center for Drug Evaluation and Research.

Manchin “will hold Dr. Califf accountable for his actions while at the FDA,” a spokesperson for the senator said in an email. They added that the agency was in need of “new, dedicated leadership” that “will fight back against the greed of the pharmaceutical industry.”

The Health and Human Services Department is “in a better position to address COVID-19, the overdose crisis, and other public health challenges because of Dr. Califf’s return to the FDA,” HHS spokeswoman Sarah Lovenheim said in an email.

Califf “is committed to building on his prior work by redoubling the FDA’s efforts,” Lovenheim said. “His experience and expertise in this area will be invaluable” while “HHS works to fully implement our new Overdose Prevention Strategy.”

Califf’s Opioid Review

Critics of the FDA’s opioid policies say the agency’s approvals of Purdue’s OxyContin and other drugs, without extensive research on addiction and other safety risks, helped contribute to the epidemic.

Califf in 2016 convened a committee through the National Academy of Sciences to provide recommendations on how the FDA could best balance the need for pain medication and reducing the risk of misuse. The committee’s report, which wasn’t released until after Califf left office, recommended that the FDA overhaul its policies on opioids.

“The reliance on very little research on addiction was a mistake,” said Margaret Riley, a University of Virginia law professor who helped produce the 2017 report. “Opioids have been tremendously profitable and the incentives to develop drugs with fewer negative public health effects have been limited.”

But Riley said some of the report’s recommendations “connect directly” with Califf’s plan for a comprehensive review, are “within the agency’s authority,” and are steps that Califf could act on right away.

The FDA could, for example, reassess currently marketed opioids using a broader public health lens that considers “new knowledge about how opioids are used and how opioids affect not only the person taking them but others who may be affected by their existence in the market,” she said.

“Use of opioids evolves over time depending on socio-cultural and market conditions,” Riley said. She added that an opioid review “should also include a commitment to develop a robust post-approval oversight system.”

Califf’s review could also look at how opioids are classified, regulated, and marketed, Gostin said.

Industry Pressure

The success of an FDA review and subsequent actions on opioids will depend on ensuring the agency doesn’t succumb to pressure from industry, some policy experts say.

“Opioid manufacturers would no doubt not welcome a comprehensive review,” Riley said. She predicted that some “may well sue the agency, arguing that such a review exceeds the agency’s authority.”

Yaniv Heled, a Georgia State law professor focusing on biomedical technologies, said Califf is well-equipped to prevent outside influence in decision-making and “knows full well how the industry works, and how the FDA works.”

The FDA’s relationship with industry gained renewed attention with the agency’s accelerated approval of Biogen Inc.‘s Alzheimer’s drug in June 2021, despite two clinical trials offering mixed signals about the drug’s efficacy. Reports emerged of unofficial Biogen meetings with FDA staff ahead of the approval decision, prompting investigations by Congress and the FDA’s inspector general.

To prevent a similar situation from happening with opioid approvals, Heled said the FDA could “really tighten the requirements for the kind of interactions that FDA employees can have with the industry.”

“Transparency and regulation is the best remedy for public trust and preventing things that might seem like corruption,” he added.

Addressing the addiction crisis is also a multi-agency effort, meaning that the FDA’s actions will “have limited value” if it doesn’t coordinate with other agencies, according to Riley. “To really tackle the opioid crisis there needs to be coordinated action by many actors,” she said.

Rahul Gupta, director of the Office of National Drug Control Policy, said in an emailed statement that he looks forward to working with Califf as the administration takes “decisive actions to reduce the supply of illicit drugs and expand access to evidence-based public health interventions that will save lives and connect more people to treatment.”

Woodcock Staying

Woodcock’s continued presence at the FDA could also be a roadblock to Califf’s efforts, said Andrew Kolodny, medical director of opioid policy research at Brandeis University’s Heller School for Social Policy and Management.

For Califf “to leave someone in a leadership role within the FDA who presided over a public health catastrophe and awful decisions that have led to a massive loss of life,” he said, “that doesn’t look like he’s taking concerns about the opioid crisis seriously.”

Others say Woodcock’s extensive experience within the FDA and knowledge of its operations outweigh any credibility concerns.

“There is no one currently at the agency who knows as much about FDA’s work,” Riley said.

Califf still must “have a clear eyed view about not only the FDA acting independently and transparently, but how the public perceives they’re acting,” Gostin said.

To contact the reporters on this story: Ian Lopez in Washington at ilopez@bloomberglaw.com; Celine Castronuovo at ccastronuovo@bloombergindustry.com

To contact the editors responsible for this story: Alexis Kramer at akramer@bloomberglaw.com; Karl Hardy at khardy@bloomberglaw.com

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