The Food and Drug Administration  (FDA) has announced plans to reclassify hydrocodone combination products as Schedule II drugs.  This change in policy is an attempt to address the recent rise in abuse of drugs like Vicodin, which has been labeled an epidemic in America.

“For the millions of American patients experiencing an acute medical need or living with chronic pain, opioids, when prescribed appropriately, can allow patients to manage their pain as well as significantly improve their quality of life,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, wrote in a press release last week.

However, in recent years, the FDA has become increasingly concerned about the abuse and misuse of opioid products, which have sadly reached epidemic proportions in certain parts of the United States. While the value of and access to these drugs has been a consistent source of public debate, the FDA has been challenged with determining how to balance the need to ensure continued access to those patients who rely on continuous pain relief while addressing the ongoing concerns about abuse and misuse.”      

This proposed change may have very real consequences for patients who rely on these drugs to treat acute or chronic pain.  The reclassification would reduce the number of medical personnel authorized to prescribe the drugs and would mean that physicians could only provide the medication in 90-day increments.  (The current classification allows physicians to prescribe 180-day supplies to patients.)  This limitation would require patients to see their physicians more frequently in order to renew the prescriptions.  Additionally, patients would have to present written prescriptions for the medication at the pharmacy, and physicians would no longer be able to call in prescriptions.

Makers of the prescription painkillers and others have argued that the regulation will have a punitive effect on the people who have a legitimate need for the medications, but advocates of the change in policy cite the growing number of overdoses linked to pain medication.  Estimates from the Centers for Disease Control now indicate that nearly seventy-five percent of overdoses are caused by opiates. 

The proposed change comes in the wake of the announcement by national pharmacy chain CVS that it will be cutting off physicians who overprescribe pain medication.

The proposed reclassification requires several additional steps, including final approval from the Drug Enforcement Agency.

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John L. Keefe
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Founding Attorney, Massachusetts Social Security Disability Lawyer