FDA set to work with insurers, PBMs to fight opioid crisis

The United States’ opioid epidemic has yielded plenty of lawsuits, investigations and damage to addicted patients and their families. But now it might spawn an unlikely collaboration between U.S. drug regulators, insurers and pharmacy benefit managers.

FDA Commissioner Scott Gottlieb plans to meet with insurers and pharmacy benefit managers to see how they might be able to limit dispensing and bring opioid prescribing closer to clinical guidelines, he told Bloomberg in an interview.

As it stands, patients who get a tooth pulled or a hernia repair can receive a 30-day opioid prescription, he said. Gottlieb told the news service he wants to see if there are ways for those groups to corral opioid use while the agency explores label changes for the addictive painkiller class. Right now, there’s “no information in the drug label about what the appropriate dispensing should be,” he told Bloomberg.

“There shouldn’t be 30-day prescriptions for a tooth extraction, or 30-day prescriptions for a hernia repair,” Gottlieb told the news service. 

RELATED: Endo caves to FDA pressure, will pull Opana ER from the market

In response, PCMA CEO Mark Merritt wrote a Monday letter to Gottlieb outlining some measures for consideration in advance of the talks. Among them are a 7-day prescription limit for acute pain and increased tools to fight fraud.

Cathryn Donaldson, communications director for the insurance industry’s lobby group AHIP, told FiercePharma insurers are already using “evidence-based treatments for abuse deterrent, pain management, more cautious opioid prescribing, and careful patient monitoring” to address the situation.

“As the national association, whose members provide coverage for health care and related services to millions of Americans every day, we believe we are a part of the solution and we look forward to working with the FDA and Dr. Gottlieb to address this important issue,” Donaldson said via email.

An overwhelming favorite by the pharma industry for the FDA’s top job, Gottlieb has taken several tangible steps to fight two popular issues—high drug prices and the opioid epidemic—since his May confirmation.

RELATED: New FDA commissioner Gottlieb unveils price-fighting strategies

On opioids, his agency has pushed for the removal of Endo’s Opana ER due to its high risks. In a statement earlier this month, the agency said it’ll continue to look at risks and benefits for opioids and will “take further actions as appropriate as a part of our response to this public health crisis.”

On drug prices, Gottlieb announced steps back in May to bolster competition and curtail “gaming” of regulations by branded pharmaceutical companies that slow generics from reaching the market.

Opioid companies have come under increasing scrutiny in recent years as the addiction crisis has developed around the country. In a lawsuit in May, Ohio officials alleged the industry borrowed a page from the "Big Tobacco playbook” and worked to convince “key opinion leaders” and professional societies of the benefits of opioids to treat chronic pain. A number of other city, county and state governments have separately sued the companies.

RELATED: In the midst of a deadly opioid crisis, Ohio sues drugmakers for marketing fraud

In response to the Ohio action, Johnson & Johnson said the “allegations in this lawsuit are both legally and factually unfounded.” Purdue said it shares “concerns about the opioid crisis and we are committed to working collaboratively to find solutions.” Teva, Endo and Allergan declined to comment.

Editor's note: This story was updated with comments from AHIP communications director Cathryn Donaldson.