Treating Sniffles with a Jail Term

Drug abuse is never-ending but ever-changing. Periodically a new drug seems to sweep America.

Although each crisis eventually ebbs, the authorities inevitably feel they must "do something," hitting the innocent as well as the guilty. As with methamphetamines.

Uncle Sam is pushing safe and effective medications behind the pharmacy counter while Food and Drug Administration regulation discourages pharmaceutical companies from developing new medicines to satisfy sick consumers and drug warriors alike.

Over-the-counter cold pills like Sudafed contain pseudoephedrine, which can be used to make meth. So politicians increasingly are declaring war on common remedies. (Next may be campaigns against other products, such as brake fluid and rubbing alcohol, also used in meth production.)

States increasingly penalize anyone with the sniffles. At least 30 states limit the amount of over-the-counter medicine consumers can purchase, restrict the number of pills per package, mandate that allergy and cold remedies be kept in locked cabinets, limit sales to pharmacies, and require sellers to maintain a registry of buyers.

Most extreme are states, like Oklahoma, which have pushed sales behind the pharmacy counter. Buyers are allowed to buy only limited quanities, must show an ID, and sign an official register. In mid-August, Oregon required that cold sufferers get a prescription.

Congress, too, is threatening to step in. In late August the Senate Judiciary Committee approved legislation to push cold remedies behind the counter nationwide.

Although meth harms some users, as John Tierney of the New York Times has pointed out, there has been no dramatic national upsurge in abuse. Former San Jose Police Chief Joseph McNamara observes: "It’s just a continuing strategy – that we have to have a drug panic." Even the Bush administration downplays super-heated talk of a meth epidemic.

Anyway, the new measures won’t do much to curb drug abuse.

The largest production facilities are located either in California, relying on pseudoephedrine smuggled in bulk from either Canada or Mexico.

Indeed, the recent U.S. crackdown has pushed production south of the border where already overwhelmed authorities are ill-prepared to respond. And given how ineffective Washington has been at interdicting other drug shipments, drug traffickers will likely bring in more than enough meth to satisfy willing customers.

However, new regulatory restrictions will greatly inconvenience anyone who gets sick. Going to a doctor for a prescription is time-wasting and expensive.

Limiting purchases to a pharmacy or behind the counter is a particular bother, especially for anyone in a rural area or who gets sick at night. Even people near big stores would have to wait in pharmacy lines.

Retailers also would suffer. Convenience stores would lose a steady business.

Pharmacies would waste space and staff handling formerly over-the-counter sales. Druggists would have to check IDs and maintain logs for cold pills rather than worry about misuse of real prescription drugs – including possible dangerous interactions with other medicines.

Retailers and sellers have responded in an attempt to preempt regulation. Some stores now limit quantities of pseudoephedrine- based medicines that can be purchased and the Consumer Healthcare Products Association, representing the over-the-counter industry, has proposed model state legislation limiting dosages per package.

Cold pill manufacturers have begun looking for alternatives.

For instance, Pfizer has created Sudafed PE, which uses phenylephrine, an older ingredient that can’t be used in meth production (but is also a less effective decongestant).

Better would be for companies to develop newer products. But FDA rules, which would run new medicines and even new combinations of old medicines through the usual regulatory gamut, penalize improvements.

The agency has expedited review of medicines with potentially life-saving uses. The FDA should apply the same principle to more mundane products, in this case directed at the common cold.

Firms should be encouraged to use phenylephrine, reformulate existing combination products, and develop new remedies with the promise that the FDA will help speed resulting medications to market.

There’s no need to compromise safety – which wouldn’t be in the interest of producers either. But FDA review should be simple and swift, lest the public be forced to rely on inferior, older products. Certainly the market should be left to determine which form of medicine is most effective.

For years unnecessarily intrusive agency regulation has delayed patient access to a host of important medications, harming health and costing lives. Today FDA regulation inhibits drug developments that could allow enhanced meth abuse enforcement without unduly inconveniencing the sick.

The meth crisis will eventually pass. In the meantime, government should stop treating people with the sniffles as if they were meth abusers.