The FDA is enmeshed in a process to find the right balance on how to approve and regulate addictive painkillers and a vote expected today is just one small piece of that puzzle-piecing exercise.
An FDA advisory panel has been taking testimony on whether hydrocodone combination pain drugs like Vicodin should be treated more seriously, Bloomberg reports. The Drug Enforcement Administration (DEA) wants to stop physician assistants and nurse practitioners from prescribing combo pills and cough medicines with hydrocodone. More importantly, it wants to limit prescriptions to one 90-day supply. Currently, patients can get 5 refills in 6 months. The panel is expected to vote after today's testimony is complete.
But this is just one of the issues facing the FDA. Next month, the agency will hold a two-day meeting to take "scientific evidence, such as study data or peer-reviewed analyses, on issues pertaining to the use of opioid drugs in the treatment of chronic pain." That includes whether pain drugs should be prescribed for limited durations and whether those should be different for various kinds of pain, say back pain versus cancer pain. It will also consider whether there should be a maximum daily dose.
At $9 billion a year, the prescription pain drug market is lucrative, but the use, and abuse, of pain meds means the category is fraught with issues. Purdue Pharma reworked its OxyContin formula to make the powerful opioid pills more difficult to crush or dissolve by addicts. Endo Pharmaceuticals ($ENDP) did something similar with its Opana painkiller. Congress has been considering whether to give the FDA authority to yank regulatory approval for generic drugs that aren't redesigned with such safety features. The patents are set to expire on both of those drugs next year, and the companies see the new formulations as a potential patent protector.
The FDA's concern was expressed earlier this month when it released its draft guidance for makers of tamper-resistant prescription painkillers. In the draft guidance, the FDA says that while opioid analgesics are important to modern pain management, their abuse has created "a serious and growing public health problem." But decisions are awaiting the FDA figuring its position out. Last month, an expert panel recommended against approval of a stronger form of hydrocodone from Zogenix ($ZGNX), not because it wasn't beneficial but because of its potential for illegal use by drug addicts. The panel suggested that approval should await an FDA decision on whether to require tamper-resistant formulations.
- read the Bloomberg story