At the third meeting of President Donald Trump’s Commission on Combatting Drug Addiction and the Opioid Crisis, the pharmaceutical industry announced support for a seven-day limit for opioid prescriptions for the short-term treatment of mild pain.
“Our announcement is candidly an unprecedented step for the industry,” said Stephen Ubl, president and CEO of the lobbying group Pharmaceutical Research and Manufacturers of America. “Given the scope of this crisis, we believe it’s the right thing to do.”
He said that his organization, known as PhRMA, supports several of the recommendations from the commission’s interim report, including stopping counterfeit fentanyl, cracking down on rogue online pharmacies, requiring mandatory annual prescriber trainings and strengthening prescription drug monitoring programs.
“Too often, individuals receive a 30-day supply of opioid medicines for minor treatments of short-term pain,” Ubl said. “Overprescribing and dispensing can lead to patients taking opioids longer than necessary and excess pills falling into the wrong hands.”
Earlier in September, commission chair and New Jersey Gov. Chris Christie said the National Institutes of Health would partner with pharmaceutical companies to share data, develop nonaddictive pain medicines and create new medication-assisted treatments for addiction.
“We had more than a dozen CEOs and senior executives of pharmaceutical companies from all over the country speak to us and agree to enter into a partnership with NIH and the Food and Drug Administration,” Christie said at the commission meeting.
Dr. Francis Collins, director of the NIH, said Trump had charged him with creating private-sector partnerships to combat the opioid epidemic. Collins said he reached out to the private sector to build relationships that would support research on pain management and new treatments for people with substance use disorders.
“They have been trapped in a rewiring of their brain, which is making it almost impossible without medication assistance to be able to recover from this addiction,” Collins said about people with opioid addiction. “While there are effective treatments, they are underutilized, and the number of options are limited.”
The director of the NIH also said that it is important to recognize the needs of the 25 million Americans who suffer from daily pain.
“We need to offer them opportunities for treatment that do not carry with them these terrible consequences,” Collin said. “Frankly, treatment of chronic pain with opioids is not very successful anyway.”
During the meeting, representatives from several pharmaceutical companies spoke about barriers to developing nonaddictive pain medications and ways to overcome those barriers. They also boasted about potential products, such as Pear Therapeutics’ new reSET app. The Food and Drug Administration approved reSET, the first digital therapeutic device to help treat substance use disorders, on Sept. 14.
A Preview of the Opioid Commission’s Final Recommendations
After opening statements, the commission held a question-and-answer session to gain more information on potential recommendations. The conversation covered a variety of approaches to help individuals recover from addiction.
Access to Full Spectrum of Medications
Most addiction treatment facilities in the United States do not offer an array of medications to treat opioid addiction. Richard Pops, CEO of Alkermes, said that unlike other areas of medicine, the treatment that patients with addictions receive is dependent on the rehab facility that they attend.
“Methadone clinics tends to give methadone,” Pops said. “Suboxone doctors tend to prescribe Suboxone. The few number of doctors who do Vivitrol tend to focus on Vivitrol.”
In other areas of medicine, doctors consider a large body of research and individual patient characteristics to create a specific treatment plan, Pops said.
Christie said that finding a way to enforce Section 303 of the Comprehensive Addiction and Recovery Act was a priority. The law requires physicians to directly or indirectly provide access to all medications the FDA has approved for opioid addiction treatment. If they’re unable to prescribe a medication, they must provide a referral to a physician who can.
Resources to Support a Partnership with Industry
Ubl and Collins talked about the resources needed to ensure that the partnership between NIH and PhRMA is effective. Collins described the need for a vigorous clinical trials network where new pain medicines can be tested on groups of similar people with similar conditions. Finding and organizing those groups would take time and resources.
“We’re ready to go,” Collins said. “But in the pretty near future, we need to figure out how we can speed this process up with additional resources.”
The NIH director also talked about the need to speed regulatory approval of new medications. He said federal resources would make it easier to determine safety and effectiveness in a timely manner.
Managing Pain Responsibly
Massachusetts Gov. Charlie Baker, a member of the opioid commission, pressed the pharmaceutical industry and government agencies on pain management reform. He praised the industry for supporting seven-day limits on opioid prescriptions, but he urged it to not settle for the bare minimum.
Several attendees discussed the need for precision medicine, saying that pain management isn’t a one-size-fits-all approach. They also discussed European protocols for pain management, which generally recommend acetaminophen and ibuprofen as the first lines of treatment for mild to moderate pain.
Insurance and Equity Issues
The Mental Health Parity and Addiction Equity Act of 2008 requires health insurance plans to provide substance use disorder benefits similar to those of other chronic diseases. For example, if an insurance plan covers six months of cancer treatment, it must also cover six months of substance use disorder treatment.
However, studies have shown that a large number of insurance plans violate the Affordable Care Act, also known as Obamacare, and the Mental Health Parity and Addiction Equity Act.
“We need the federal Department of Labor to step up and enforce the parity act,” Christie said. “I think states vary in terms of how they enforce it depending on their structure, but in my state I only wind up regulating 30 percent of the employer-based health insurance plans. The rest are regulated by the federal Department of Labor.”
Several pharmaceutical representatives also stressed the need for insurance plans to reimburse patients for new pain management treatments or for medications to treat opioid addiction.
“If we develop a whole lot of powerful, nonaddictive pain medicines but the third parties won’t pay for them, then we haven’t achieved very much,” Collins said.
Christie said that the commission’s next meeting will be with insurance providers. The date of the meeting has not been announced. The commission delayed its deadline for delivering a final report to the president to Nov. 1.