- The Washington Times - Thursday, September 2, 2010

ANALYSIS/OPINION:

The Food and Drug Administration, consistently overstepping its food-safety charter to promote itself as enlightened custodian of the masses, has already spent the summer waging a war to further expand the nanny state - e-cigarettes, plastic containers and cough medicines have all become targets for an expanded regulatory regime and steppingstones to broader FDA overreach.

The assault on cough medicines is particularly troubling: The FDA has announced it will hold a hearing in September to discuss the safety of dextromethorphan, an ingredient in more than 100 common cough and cold medications. Absent any compelling evidence that abuse of the drug is widespread or growing, the FDA has decided what recreational use of cough medicines does exist is egregious enough to require redress.

This response is to push cough medications that contain dextromethorphan behind the pharmacy counter. Requiring a prescription for essentially harmless medicines increases costs - in terms of time spent visiting a doctor’s office and money spent on health care - at a time when consumers already are suffering. The looming implementation of Obamacare already ensures health care costs will rise, hitting taxpayers twice with increased taxes to pay for the bill. For its part, the FDA should be extremely concerned about placing yet another onerous burden on the backs of overtaxed health care consumers.

However, it seems the FDA has followed the example set by congressional Democrats and President Obama in the health care debate, ignoring the market forces at work in the drug industry and forging instead an obtuse response to an overstated problem. Drug manufacturers, properly aware of the negative impact abuse of their products could have on their brand, take great care to label properly and educate consumers on the risks associated with their products. The burden is on the FDA to show those efforts lack the teeth to respond appropriately to a threat of abuse - it has been unable to do so.

This latest campaign is particularly disconcerting for what it could mean down the road for the regulatory paradigm. While recreational use of medicines containing dextromethorphan may occur, the rate of incidence is low. A study released in 2009 by the Substance Abuse and Mental Health Services Administration showed that approximately 0.7 percent of drug-related emergency room visits involved dextromethorphan. Thirty-one percent of those were results of adverse reactions to medicine that was used as directed. This number drops even lower when controlling for accidental overdoses.

What’s more, the FDA is promoting a cure that is worse than the disease: Studies show that prescription drugs are twice as likely to be abused as cough medications. This suggests that pushing cough medicines containing dextromethorphan behind the counter will do little to stem concerns regarding its abuse, and perhaps exacerbate them.

An enormous amount of medicine containing dextromethorphan must be consumed to produce a high. Allowing the FDA to require a prescription for such a benign medication raises concern over what the agency would consider to be a tenable threshold for regulatory concerns.

The engine of FDA regulatory policy is the reactionary concern that because bad behavior exists, everyone should be punished. This is a ludicrous notion: Should paper be outlawed because it is used to roll illegal cigarettes? Can the government make computers illegal because they are used to pirate software? Does it make sense that millions of cold sufferers should be punished with higher prices and expensive doctor visits to relieve their coughs because some people have used the same product for illicit purposes?

The answer to all of these questions, of course, is no. So if you think you should be able to quiet a pesky cough without an expensive and lengthy doctor’s visit, think again. The FDA, perpetual provocateur of state intervention when markets and personal responsibility will do, is poised to manufacture another crisis to expand the scope of its power. This leap into the regulatory fray could not only make the lives of cold sufferers unnecessarily more miserable, it also sets the stage for an expansive view of FDA authority, in which even the most tenuous nexus between harm and its likelihood can merit regulatory action. If you thought Obamacare represented an unprecedented step into the nanny state, just wait for the dystopia envisioned by the FDA.

Mattie Corrao is government affairs manager at Americans for Tax Reform.


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