FDA’s Opioid Safety Strategy Under Review

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By Sara Merken

A government agency evaluation of how the FDA is fighting opioid abuse should address specific issues such as physician training and drug labels, health-care experts say.

The Department of Health and Human Services Office of Inspector General (OIG) announced in its October work plan update that it will evaluate the FDA’s Risk Evaluation and Mitigation Strategies (REMS) for prescription opioids. The OIG is expected to issue the evaluation in 2019, the agency release said. Consumer representatives and a lawmaker contacted by Bloomberg Law suggested issues they’d like the government inquiry to look at.

A 2007 law gave the Food and Drug Administration authority to require pharmaceutical companies to create REMS when the agency concludes that the risk of using a drug outweighs the benefit. In describing its work plan generally, the OIG says it provides “independent and objective oversight that promotes economy, efficiency, and effectiveness in the programs and operations of HHS.” The review of REMS comes as President Donald Trump Oct. 26 officially declared the opioid abuse crisis a public health emergency.

In describing this specific effort related to opioid risk plans, the inspector general said it will “describe how FDA determined the need for opioid REMS and determine the extent to which FDA has held pharmaceutical companies with required opioid REMS accountable for REMS assessments.” The OIG also will determine the extent to which FDA has held opioid REMS sponsors accountable for goals “to mitigate risks of misuse, abuse, addiction, overdose, and serious complications because of medication errors.”

Representatives of the Pharmaceutical Research and Manufacturers of America declined to comment on the inquiry when contacted by Bloomberg Law.

Senator’s Concerns

“The FDA cannot ensure that the public is protected from the known risks of opioids if it is not consistently requiring REMS for every opioid and if it is not effectively monitoring their performance and responding if they are inadequate,” Sen. Ed Markey (D-Mass.) told Bloomberg Law through a spokesperson Oct. 24.

“It is imperative that we take a close look at this program and these strategies to ensure they can work as intended,” he said.

Markey also wrote the FDA a letter in April 2016, requesting information on how the agency monitors and analyzes REMS for opioids. A Markey staffer told Bloomberg Law Oct. 26 about the FDA, “They promised us, more than a year later, that they would provide it to us this week.”

Necessary Evaluation

“The problem with REMS is that logically they make sense, but that doesn’t mean that they have been evaluated to see if they actually work,” Diana Zuckerman, President of the National Center for Health Research, told Bloomberg Law Oct. 25.

An FDA goal through REMS is to increase the number of opioid prescribers who receive training on safe prescribing and pain management. The training is voluntary, and is currently only for some physicians who prescribe certain opioids, Zuckerman said. The evaluation should examine the voluntary nature of the trainings, as many doctors choose not to complete them, she said. Her group is a nonprofit that encourages new and more effective programs and medical treatments.

The FDA announced in July 2017 that REMS will require the training to be made available to all health-care providers involved with pain management, in addition to physician prescribers. While extending this education opportunity is a step in the right direction, as long as the training is voluntary, it “doesn’t do the job, given the crisis situation that we’re in,” Zuckerman said.

The Drug Enforcement Administration (DEA) should require the training in order for physicians to receive licenses to issue controlled substances, Michael Carome, director of the health research group at the consumer advocacy group Public Citizen, told Bloomberg Law.

The FDA doesn’t regulate physicians, and cannot force particular doctors to take the training. The DEA can require physicians to demonstrate that the appropriate knowledge is gained from training sessions, Carome said. The DEA is part of the Department of Justice.

Another key question to be answered in the OIG evaluation is to what extent doctors understand the meaning of certain FDA drug labels, Zuckerman said.

The agency often labels drugs that are more difficult to crush as abuse-deterrent, which does not necessarily mean that the drug is nonaddictive, she said. Zuckerman encourages the FDA to use accurate terms when describing particular products to avoid doctor and patient confusion and clarify that a drug can be highly addictive.

“If they are crush-resistant, just label them as crush resistant,” she said.

REMS to Include More Drugs

The two main REMS for prescription opioids are for extended-release, long-acting (ER/LA) drugs and for transmucosal immediate release fentanyl (TIRF), an FDA spokesperson who asked not to be named told Bloomberg Law. Each strategy addresses a variety of products, and was approved in 2012 and 2011, respectively.

Senators have urged the FDA to adjust REMS to include a more comprehensive list of opioids. A group of six senators, including Markey and Sen. Richard Blumenthal (D-Conn.) demanded tht the agency require REMS for immediate-release (IR) opioids, which make up over 90 percent of all opioids prescribed, a February 2016 letter to the FDA said.

The FDA announced in September 2017 that REMS will include IR opioids. The agency notified 74 manufacturers of the change, which may take a year to finalize, FDA Commissioner Scott Gottlieb said in an agency blog post, noting that America is “awash” in IR opioids.

OIG Workplan Changes

The OIG’s workplan was previously updated on an annual basis, but the agency switched to monthly updates in June with the goal of better public transparency.

The monthly updates present a greater challenge for health-care compliance officers, William T. Mathias, a health-care attorney with Baker, Donelson, Bearman, Caldwell & Berkowitz in Baltimore, Md., told Bloomberg Law.

Under the old system, compliance officers were able to review their operations against the OIG’s workplan once a year, whereas as now they’re forced to conduct a monthly review when the OIG updates arrive, Mathias said.

—-With assistance from James Swann.

To contact the reporter on this story: Sara Merken in Washington at smerken@bna.com

To contact the editor responsible for this story: Brian Broderick at bbroderick@bna.com

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