Turning the tide

Why FDA’s plans to combat opioid abuse will create new regulatory precedents

FDA’s plans to blunt the epidemic of opioid abuse, addiction and overdoses will stretch the boundaries of FDA oversight, creating precedents that could be applied in the future to other drug classes and health problems.

Policies FDA may adopt include creating indications based on population effects rather than the effect of a drug on individual patients and using a comparative safety standard to remove drugs from the market if safer alternatives are available (see “Policy Innovations”).

The ideas are aimed at stimulating the development of non-addictive pain drugs and novel addiction treatments, and enhancing the safety of marketed products, FDA Commissioner Scott Gottlieb told BioCentury in a recent interview.

Many of the opioid policies FDA has implemented this year and those it is now considering are intended to reach beyond drug manufacturers to affect the actions of other parts of the healthcare system. The agency is looking for ways to influence physicians’ prescribing decisions, and to change the coverage and reimbursement practices of public and private payers.

FDA also is trying to change the way the public and lawmakers think about addiction, to destigmatize the problem and persuade people to think of it as a medical condition rather than a character flaw. In this respect, the agency’s actions are reminiscent of early efforts to combat the AIDS epidemic -- and as with AIDS, it is encountering strongly held views, getting dragged into medical controversies and being forced to weigh competing priorities.

“We’ll need to touch clinical practice in ways that may make certain parties uncomfortable.”

Scott Gottlieb, FDA

Gottlieb does not intend to wade into the medical controversy over the relative merits of opioid agonists and antagonists to treat addiction but he is speaking out against widely held misconceptions about the value of anti-addiction therapies (see “Agonizing or Antagonizing?”).

Criticism that FDA is exceeding its authority, and that it will reduce access to pain treatments for patients who are unlikely to abuse opioids are inevitable. Those criticisms won’t deter FDA from acting, because the problem is too serious for half-measures, and the agency recognizes its past attempts to address opioid abuse have been inadequate.

Gottlieb told BioCentury that during the time he was FDA deputy commissioner for medical and scientific affairs, from

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