The FDA Wants Stricter Regulations On Prescription Painkillers As Overdose Rates Soar

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The Food and Drug Administration (FDA) announced on Thursday that it will seek to reclassify so-called “hydrocodone combination products” — drugs that mix the opiate hydrocodone with milder painkillers like acetaminophen, such as the popular Vicodin — from its current Schedule III designation to Schedule II. That move, which would ultimately make it harder to get prescriptions for these medications, comes in the wake of increasing evidence that the United States is experiencing a prescription painkiller epidemic that’s claiming lives at a record level.

“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,” wrote Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, in a press release.

“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.”

Prescriptions for painkillers rose by more than 300 percent between 1999 and 2010, while painkiller overdose deaths spiked four-fold over the same time period. That makes prescription painkiller overdoses the second most common cause of accidental death in the United States and is the cause of three out of every four medication-related deaths. The vast majority of the painkillers that lead to overdoses contain opiates like hydrocodone.

Reclassifying drugs that contain hydrocodone to Schedule II — a list that includes stronger opiates like morphine and oxycodone — would mean that doctors can only prescribe it to patients in 90-day increments. After that, the patient would have to return to his or her physician to get a refill.

There are still several steps that the FDA must take in order for the proposed reclassification to take effect, including submitting an official recommendation to the Department of Health and Human Services and getting final approval from the Drug Enforcement Agency to change the drug designation.

In the meantime, private companies are also taking steps to tackle prescription drug misuse. In August, CVS Pharmacy announced that it would cut off prescription privileges for doctors who are perceived to over-prescribe strong painkillers.