PAINKILLER LAW: Schedules, Politics and Pain at the FDA

The FDA last week issued a major recommendation to try and combat the epidemic of prescription drug abuse in the U.S. After months of debate, hearings and deliberation, the agency decided that current Schedule III painkillers like Vicodin should be moved up to Schedule II of the Controlled Substance Act, making the drugs harder to prescribe, harder to refill, and tougher to justify. Schedule II drugs, like Oxycontin, are according to the law’s definition medically acceptable and currently prescribed but with a very high potential for abuse and addiction. Schedule III drugs, containing the painkiller hydrocodone (Vicodin, for example, is in this class) are still considered risky but a little less so, at least as they’ve been classified up to now.

This post is not an advocacy piece about whether or not the FDA did the right thing. Instead, I try and give a sense of how complex a question rescheduling is, because of the competing policy concerns, the politics involved, and because of the politics, the huge amounts of money being thrown at various players in the process.

-Patients’ advocacy groups oppose the change because legitimate, non-abusing chronic pain patients are worried that they will see even more scrutiny of their doctors and themselves, and they are most worried about one day having less access to the pain relief medication they need just to function normally every day.

-Physicians’ groups like PROP (Physicians for Responsible Opioid Prescribing) favor the change, because they do not see an alternative for curbing the enormous supply of opioids in the country and the ease with which the drugs are sometimes unnecessarily and sometimes recklessly and sometimes criminally prescribed. Props to PROP: The group has always tried to make clear that it is not out to deprive legitimate patients of needed medication; PROP’s reassurances sometimes, though, get lost in the whirlpool of emotion that accompanies this debate.

-Pharmaceutical manufacturers try and maintain somewhat of a discreet and seemingly patient-oriented presence at the hearings and throughout the conversation.

-HOWEVER, a congressman from the Midwest has been harping on the FDA to not make the change, saying he’s on the side of patients who don’t want to lose access to needed medication. It just so happens that this same congressmen is the #1 congressional recipient of Big Pharma lobbying money in the House of Representatives. So, the companies who believe a scheduling change poses a financial threat to them are obviously making their presence and position known in very important ways.

-A West Virginia congressman, meanwhile, is one of the strongest advocates FOR the scheduling change, his state having experienced very high death and abuse rates related to prescription drugs.

Ultimately the US Health and Human Services Department, to which the FDA belongs, has to make the final decision. If HHS Secretary Kathleen Sebelius survives the information technology debacle of the Affordable Care Act’s rollout, she’ll have another huge call to make – this time about drug schedules, politics and pain.

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