Managing painkillers: The FDA must monitor the tougher regulations

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In a major policy shift that affects tens of millions of patients, the federal government is tightening the prescription rules for some common painkillers. In moving highly addictive hydrocodone-combination products such as Vicodin from a Schedule III class to Schedule II, the Food and Drug Administration aims to lessen abuse, lower addiction rates and alleviate the nation’s opioid and heroin epidemic.

The change subjects Vicodin, Lortab and their generic equivalents to the same prescribing rules as oxycodone and morphine. It has enormous potential benefits, including making fraud more difficult.

But it could burden medical providers while creating hardships and higher costs for the 50 million Americans a year who get hydrocodone — the most widely prescribed drug in the United States — to ease chronic pain.

The new FDA rules, which take effect in a month, restrict patients to one 90-day supply of medication and require them to see a medical professional to get refills. They limit who can prescribe the drugs and eliminate prescription call-ins.

Under Schedule III classification, a Vicodin prescription could be refilled five times before the patient had to see a physician again. Looser controls have inevitably led to more diversion of Vicodin and other controlled substances onto the street, where they are bought illegally.

Over the next year, the FDA and Congress must monitor the new rules to assess whether they are effective or cause undue burden to patients in chronic pain.

Prescription drug abuse kills more than 20,000 Americans a year — three times as many as in the late 1990s. The problem has pitted advocates who fight addiction against pain management specialists, long-term care providers and some chronic pain patients, who fear tighter rules will make it too difficult for them to get the medications they need. Both sides have legitimate concerns.

In this balancing act, moving hydrocodone-combination drugs to a more restrictive class is prudent. Serious, systemic efforts to curb the nation’s addiction crisis are overdue. But the FDA must also ensure that the promises of tighter access outweigh the perils.

Meet the Editorial Board.


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