By MATTHEW PERRONE, AP Health Writer
WASHINGTON (AP) — As deaths from opioids rose in the US in 2016, the incoming head of the Food and Drug Administration (FDA) promised a “comprehensive review” of prescription painkillers. in hopes of reversing the worst overdose epidemic in American history.
Dr. Robert Califf even personally commissioned a report from the nation’s top medical advisers that recommended reforms, including the possible removal of some drugs from the market. But six years later, opioids are claiming more lives than ever, and the FDA has not removed a single drug from pharmacy shelves since the report was published. In fact, the agency continues to bring new pain relievers to market: six in the last five years.
Now, Califf is back in charge of the FDA, facing skepticism from lawmakers, patient advocates and others over his long-promised reckoning for drugs like OxyContin and Vicodin, which are blamed on large part of causing a two-decade rise in opioid deaths.
“All the concerns that we had at the time about opioids are still there. We still have a really huge problem,” said Richard Bonnie, a public health expert at the University of Virginia who chaired the committee that wrote the report.
Bonnie and her co-authors say the FDA appears to have incorporated several of their recommendations into recent decisions, including broader consideration of a drug’s public health risks. But they say there is more to do.
In an interview with The Associated Press, Califf said a new internal review of opioids has been underway for months and the public will soon “hear a lot more about this.” While the review will look at past FDA decisions, Califf suggested the focus will be on future policy.
“It seems like people love to look back and find fault, but I’m much more interested in learning so we can move forward and make the best decisions for what we need to do today,” said Califf, who split his time between Duke University and working for Google after leaving the FDA in 2017 following the election of President Donald Trump.
The 453-page report issued five years ago this month by the National Academies of Sciences laid out a strategy to reduce the overprescription and misuse of opioids, with a particular focus on the FDA.
At the heart of the recommendations was a proposal for the FDA to reassess the dozens of opioids on sale to determine whether their overall benefits in treating pain outweigh the risks of addiction and overdose. Those that don’t should be pulled from the market, the group said.
The lack of swift action underscores the glacial pace of federal regulation and the legal hurdles to recalling drugs once considered safe and effective.
“It’s really hard for the agency to take a drug off the market once it’s been approved,” said Margaret Riley, a professor of food and drug law who consulted on the report.
Last year, overdose deaths in the US skyrocketed to a record 107,000, driven overwhelmingly by fentanyl and other illegal opioids.
Opioid prescriptions have fallen about 40% in the last decade amid restrictions by hospitals, insurers and state officials. But drug-related deaths remain between 13,000 and 14,000 a year. And studies suggest that people who become addicted to opioids continue to start with prescription opioids, before switching to cheaper heroin and illegally manufactured fentanyl.
“If Dr. Califf is serious about addressing the drug epidemic, the FDA should immediately implement” the report’s recommendations, Sen. Joe Manchin of West Virginia said in a statement.
Manchin told the AP that he requested an update in April on the FDA’s progress on the recommendations, but did not receive a response. He was one of five Democrats from states hardest hit by opioids who voted against Califf’s confirmation in February.
In response to questions about the recommendations, the FDA provided a list of actions it has taken on opioids, some of which predate the report. The agency said it has acted on “almost all” of the recommendations, improving prescriber education and labeling, convening meetings and improving data collection.
“I think what you’ve seen is that the agency is grabbing some of the low-hanging fruit and only up to a certain level,” Riley said.
Despite increased scrutiny, the FDA continues to bring new pain relievers to market. Many of the drugs have formulations designed to make them more difficult to misuse, such as hard-to-crush coatings that discourage inhalation or injection.
Califf has said the FDA is bound by his regulations: Companies only need to show that their drugs work better than a placebo, and the agency cannot require new opioids to be safer or more effective than those already on the market. He told Senate lawmakers in April that doing so might require legislation from Congress.
One of the report’s authors disagreed.
“I think the FDA has a lot of flexibility right now to say, ‘Look, given these circumstances, we don’t think a placebo-controlled trial is appropriate,'” said Dr. Aaron Kesselheim, an attorney and professor of medicine at the School of Medicine. Harvard Medicine.
As for older opioids like OxyContin, Califf says that as the agency gets more evidence about the risks of opioids, it will “aggressively look at relabeling.”
But the delays in obtaining that evidence illustrate how slowly the FDA process is moving. It’s been nearly 10 years since the agency asked long-acting opioid makers to conduct a dozen studies on the risks and effectiveness of their drugs.
The main clinical trial looking at opioids for chronic pain has been delayed from 2019 due to repeated changes to its design. And the results of seven other studies published in 2020 don’t give a clear picture of whether the drugs are really safe and effective for long-term use.
“We have to have the data, and we can’t accept excuses that it’s hard to do,” Califf said. “That’s not going to be acceptable.”
Riley said the data the FDA is seeking will be critical in providing the evidence needed to remove opioids from the market, which will likely face years of pushback from the industry.
“The question for me is whether the agency will really have the courage to use those tools to start extracting drugs,” Riley said. “Do they have the will to do it?”
Follow Matthew Perrone on Twitter: @AP_FDAwriter.
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