FDA again finds itself playing role as pain med police

The FDA's move to put tighter controls on combo pain drugs like Vicodin that contain hydrocodone with over-the-counter painkillers like aspirin have it again balancing its role as a regulator concerned about the safety and effectiveness of drugs with growing concerns about overdose deaths and addition. Under pressures from politicians and police to put new restrictions on the most abused drugs, the FDA has taken a series of steps this year that put it more in the role of public safety steward than its traditional role.

The FDA Thursday recommended that doctors no longer be able to call in prescriptions, instead requiring patients to show up at their pharmacies with one to get such drugs. It also suggested restricting refills to within 90 days, instead of the 180 now allowed, The New York Times point out. Some patients get refills 5 or 6 times during that 6-month period without their doctors being aware. The recommendation is to the Department of Health and Human Services and to the Drug Enforcement Agency (DEA), which has the final say, but which has been seeking tighter controls on the drugs for years because of their abuse. Nearly three of four prescription drug overdoses are caused by opioid painkillers, according to data from the Centers for Disease Control and Prevention (CDC), Reuters reports.

The FDA has taken a number of steps this year that clamp down on the most abused drugs. The agency last month said it was "invoking its authority" to require that long-acting and extended-release opioid painkillers only be used for severe pain and only when other measures don't work. In April, the FDA took the unusual step of banning any generics of the original long-acting formulation of the best-known drug in the category, OxyContin. It said the danger of abuse outweighed the benefits of a cheaper version of the product. It also, for the first time, gave OxyContin maker Purdue Pharma the right to put a specific claim on its new version of the drug that it is abuse-deterrent.

The agency is encouraging pain drugmakers to develop new tamper-resistant drugs. It also in July approved Zubsolv, a drug from Swedish drug developer Orexo for treating opioid addiction, a problem the company says affects nearly 5 million people in the U.S. and leads to about 17,000 deaths annually.

Some doctors who treat chronic pain have warned that the agency is making it harder for people with difficult conditions to get treatment. But FDA CDER Director Janet Woodcock said the agency 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."

- read the New York Times story (sub. req.)
- here's the Reuters story
- here's Janet Woodcock's statement