From gag rule to speech at the point of a gun

In Atlas Shrugged, the apes in power try to make a productive man say what they want him to say by holding a gun to his back -- and the FDA is now doing the same thing to the makers of painkillers. (Thanks to Jared Rhoads of the Lucidicus Project, from whom I first heard about this story.)

The FDA has its knickers in a twist because prescription painkillers are often used, not for the purpose for which they are prescribed, but to get high. Because our nanny state can't possibly allow a man to make his own choice about what he puts into his own body, and to bear the consequences if he makes a mistake, the FDA is joining the DEA (and probably other alphabet agencies) in trying to stamp out prescription painkiller abuse.

The issue that FDA wants addressed is that the vast majority of prescription painkiller users do not get the drug because it was prescribed to them by a doctor. They get it from a dealer, or because someone they know was prescribed the pills and passed them on.

So FDA's solution is to force the manufacturers of opioid painkillers to develop anti-abuse education materials. These materials are supposed to persuade the patient for whom the drugs are actually prescribed not to give them away, and to educate the doctor on how to talk to patients and/or recognize that a drug he's prescribing may not be going to the patient it's being prescribed for.

Never in this process is it assumed that a) the patient has a brain, probably knows that opioid painkillers have addiction potential (duh!), and knows exactly what he is doing if he decides to supply drug to someone else; b) the doctor wasn't born yesterday (but also is under huge time constraints imposed by our current healthcare system, itself the result of government regulations, and therefore may not have time to ask all the questions required to determine whether a patient is really in pain or is a "drug seeker"); and c) that all parties involved, including the drug abuser, have a right to enter into whatever mutual agreements they please, including agreements that result in someone getting high on pain pills!

Instead, the FDA is holding a gun to manufacturers' backs and telling them they have 120 days to produce educational materials (which, according to the agency's logic, will surely cause patients, sheep-like, to stop handing drugs to their friends and family) and submit them to the agency. (The gun, of course, is the unspoken but palpable threat that FDA will force manufacturers to pull these products from the market.) As Jared Rhoads has pointed out, 120 days is just about enough time, should the manufacturers start working feverishly right now, to get the materials reviewed by their internal legal and regulatory personnel. Then the FDA gets to look at the materials and force the manufacturers to make additional changes as it sees fit.

Unfortunately, unlike in Atlas Shrugged, the manufacturers are not reacting by pointing out the gun at their backs for what it is, and proudly standing up for their right to sell their products without government interference. In fact, one manufacturer's representative meekly says, "We really support [FDA] efforts...we think education is the right way to tackle this issue," as the Wall Street Journal reports. Not that I can condemn them for it -- as Ayn Rand said, morality ends where a gun begins, and these producers recognize that they risk losing their entire operations should they fail to comply with the FDA's demands. But I can condemn the FDA for trampling on the rights of producers and patients alike.