Panel: The FDA Desperately Needs to Review its Approach to Opioids
In a report, the National Academy of Sciences, Engineering, and Medicine (NASEM) is calling on the U.S. Food and Drug Administration (FDA) to review the safety and effectiveness of opioid painkillers. The panel of experts says monumental changes are needed to the way in which physicians treat pain, their patients cope with pain, and government and private insurers support individuals’ treatment for chronic pain. 
The panel wrote that:
“It is therefore ethically imperative to couple a strategy for reducing lawful access to opioids with an investment in treatment for the millions of individuals [already addicted to opioids].
The FDA commissioned the panel in 2016 to shape advice for how the agency should tackle the nation’s opioid epidemic. Many experts, including those on the panel, say the answer to the problem lies in regulating drug companies, as well as prescribers.
As we speak, lawmakers in Washington are debating a healthcare bill that would reduce access to addiction treatment – the polar opposite of what the panel calls for in its comprehensive report. What is needed, panel members say, is for states and the federal government to provide “universal treatment to addiction in hospitals, community-based programs, jails, and prisons.
The topic is a bone of contention for many people who don’t believe taxpayers should have to foot the bill for such treatment. But according to the panel, it is the only way to bring an eventual end to the opioid crisis sweeping America. Make no mistake about it – it is going to take years to gain control over the situation.
A member of the report committee, Dr. Aaron Kesselheim of Harvard Medical School said:
“Our recommendation is for a much more systematic approach, integrating public health decision-making into all aspects of opioid review and approval. It would be an ambitious undertaking.” 
While the panel stopped short of acknowledging that the war on drugs has not worked, it urged states to reject the current trend of cracking down hard on illicit drug use. This, it said, will reduce harm to opioid users who have turned to the streets to supply their habit.
Instead, the panel said that states should adopt needle exchanges, safe havens for those who inject drugs, and wider access to naloxone – a drug that reverses overdoses from opioids, including heroin. 
In deciding how to regulate opioids, the FDA should study how the drug will affect patients’ families, society at-large, and the black market for drugs, the panel continued.
“This is in distinction to the traditional approach that the FDA takes when it evaluates products. But the particular characteristics of opioids, we believe, requires a certain amount of what we term ‘opioid exceptionalism’ from the regulator.
… Overzealous promotional and financial relationships between the pharmaceutical manufacturers of opioids and physicians through the ’80s, ’90s, and 2000s, I think, at this point, has been shown to be a contributor to overprescribing in this area.” 
Other recommendations by the panel include:
- Requiring drug companies to follow stricter rules for marketing opioids than they would for other drugs.
- Developing campaigns to inform doctors and patients about other was of managing chronic pain. These campaigns should not be run by drug companies, however, even though many drug companies sponsor ongoing pain-management education programs for physicians.
In 2016, the CDC released fresh guidelines intended to limit the prescribing of opioids, though there is no legal mandate for physicians to follow them. The agency recommended, among other things, that:
- Doctors don’t immediately prescribe opioids to treat pain. Instead, physicians should prescribe non-drug interventions first, such as exercise therapy and weight loss.
- When a doctor does prescribe an opioid, he or she should start the patient on the lowest dose possible, and prescribe immediate-release opioids for short periods of time, rather than for weeks or months at a time.
- Doctors should urine-test patients to make sure they are following the prescription’s directions.
Also in 2016, the FDA published draft guidelines outlining testing standards for harder-to-abuse generic opioids. Under those guidelines, the FDA can only approve a generic painkiller if the maker can prove it is the bioequivalent of a brand-name medication. Prior to that, generic drugs were not individually scrutinized for safety and efficacy the way that brand-name drugs were.
Additionally, the FDA required black-box warnings – the FDA’s most serious drug warning – on all fast-acting opioids concerning the risks for addiction, misuse, overdose, and death.
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|Julie Fidler is a freelance writer, legal blogger, and the author of Adventures in Holy Matrimony: For Better or the Absolute Worst. She lives in Pennsylvania with her husband and two ridiculously spoiled cats. She occasionally pontificates on her blog.