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June 2012
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STAY OUT Politicians err by wading into FDA decision-making

It is election season, and a number of state and federal candidates are marking the occasion by becoming armchair drug regulators, to the detriment of law-abiding sick people.

Fox News reports that several members of Congress and state attorneys general are teeing up a new drug called Zohydro ER, seeking to block the recently approved painkiller from being sold in the U.S.

Zohydro is an extended release form of hydrocodone, an opiate painkiller. Food and Drug Administration Commissioner Margaret Hamburg says the new drug is a needed option for some of the 100 million Americans who suffer from chronic pain every year. Hamburg strongly defends the drug's approval, saying its benefits to patients far outweigh the negatives.

Those negatives are, of course, potential abuse of the drug by people looking for a high. Critics want to ban the medication because they believe the drug is too easily ground up, snorted or injected. They call it "heroin in a pill."

Among those leading the charge to ban the pill is West Virginia Democrat Joe Manchin, who along with New York's Chuck Schumer is trying to force the FDA to reverse its approval. They have support, according to Fox, from Kentucky Sen. Mitch McConnell, Lamar Alexander of Tennessee and Oklahoma's Tom Coburn on the Republican side. West Virginia and Kentucky are among the nation's leaders in prescription drug abuse and overdose deaths, which explains the interest of Manchin and McConnell. The politics is obvious. Lawmakers always want to appear to be "doing something" about a problem.

Philosophically however we disagree with this initiative on a couple of grounds.

One is the effort by politicians to substitute their judgment for that of the medical experts who populate the FDA review panels. Getting FDA approval for any drug these days is no small chore. It is far from a rubber-stamp agency; in fact at times it seems to go too far in the other direction, particularly with regard to promising but expensive cancer drugs. We really don't think being an attorney general or a member of Congress is sufficient qualification to second-guess the FDA panels of scientific experts.

Our second concern is the growing tendency of the government to punish law-abiding, suffering citizens in the name of stopping drug addicts and miscreants from abusing drugs.

We have been and continue to be critical of elements of Kentucky's "pill mill" law for precisely these reasons. In the name of making life harder for drug abusers, Kentucky legislators decided to make it tougher, and more expensive, for everyone else. Under the banner of cracking down on abuse of painkillers, state regulators used the law to extend their reach to many other forms of commonly prescribed medications. Kentuckians who legitimately use controlled substances for any extended period must now prove they are not drug abusers by submitting to periodic urine tests (usually paid for from their own pockets) in order to get their prescriptions re-authorized. The state's entire population of law-abiding, chronically ill people has thus been put on parole.

Now on a national level congressmen and other politicians want to deny millions of chronic pain sufferers a new drug the FDA says they should have, probably because politicians think the issue polls well. Perhaps it does. But it's a disservice to millions of Americans. It's also a dangerous game.

You would think politicians would have learned a lesson from the fallout of the Obamacare debacle about the political danger of excessive government intrusion into people's personal health care choices. Not so, apparently.

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