FDA’s ‘pay for play’ plan
Drug pushers can make big money, but for most of them, $25,000 in a single transaction is the stuff of dreams. Maybe they ought to get into a different line of work-holding meetings to discuss how the government can curb drug abuse.
It happens. According to a published report, the Food and Drug Administration is working with two academic researchers to develop new rules for prescription painkillers. The researchers set up panel discussions on the subject.
Pharmaceutical companies wishing to participate paid as much as $25,000 per meeting.
When Sen. Joe Manchin, D-W.Va., heard about that, he hit the ceiling. He has called for a Senate investigation of what he calls a “pay for play” system of discussing issues such as controls over painkiller prescriptions and sales.
Manchin has more reason than senators from other states to be concerned about drug abuse. A report released just days before he demanded the Senate probe disclosed that West Virginia has a much higher rate of drug overdose deaths than any other state.
During 2010, overdoses killed 28.9 people per 100,000 in our state. The next highest rate was New Mexico, at 23.8.
And the problem has grown much worse during recent years. In 1999, the drug overdose death rate in West Virginia was just 4.1.
Many overdose deaths involve drugs that are legal but misused-primarily painkillers such as Oxycontin, Vicodin and Lortab.
How to regulate those drugs is an ongoing debate.
Drugs are designated in certain classes by the FDA, with one determining factor how addictive they are. Many painkillers are Class III drugs. One ramification of that is that physicians can write prescriptions allowing patients to obtain up to six months’ supplies of the pills.
Manchin and others worried about painkiller abuse think the drugs ought to be in Class II-with prescriptions legal for no more than 30 days’ worth of pills.
Obviously, that would make it tougher for pushers to obtain the large supplies of painkillers on which they depend to turn profits. Not just incidentally, it also could allow doctors to spot signs of dependence on painkillers before patients become hooked.
Pharmaceutical companies don’t like the proposal, Manchin says.
But clearly, it’s a good idea. There’s no good reason for anyone to need a six-month supply of painkillers all at once. Getting 30-day prescriptions renewed isn’t a big deal. Some physicians will renew prescriptions over the phone-if they have no reason to think they ought to take a look at the patient before doing so.
FDA officials seem a bit mystified by Manchin’s anger. One called the meetings in question “an essential, collaborative effort.”
Well, perhaps so-if you could afford the $25,000 for the right to be involved in it. But what if you’re someone with concerns about painkillers and weren’t able to attend one of the meetings? What if-and this is a favorite tactic of people who want to limit input that might steer a conversation where they don’t want it to go-you weren’t even aware the meetings were being held?
Manchin is absolutely correct in wanting to know more about the pay-to-play racket-and why the FDA went along with it.
How much money was collected? Where did it go? What companies paid to get their opinions across to the FDA?
And perhaps most important, does this happen a lot when government agencies are developing policies?
More West Virginians are killed by drug overdoses than in traffic accidents. Nationwide, more people are killed by prescription drugs than by heroin and cocaine combined.
We need all the help we can get to end the plague. Yet the FDA seems to think it’s fine to charge $25,000 per meeting to allow people with vested interests in selling more drugs to influence policy.
Go get ’em, Joe.
EDITOR’S NOTE: Mike Myer is executive editor of The Intelligencer and the Wheeling News-Register. He can be reached via e-mail at email@example.com