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 “dosomething,” hitting the innocent as well as the guilty. As with methamphetamines.
Uncle Sam is pushing safe and effective medications behind the pharmacy counter whileFood and Drug Administration regulation discourages pharmaceutical companies fromdeveloping new medicines to satisfy sick consumers and drug warriors alike.
Over‐the‐counter cold pills like Sudafed contain pseudoephedrine, which can be used tomake meth. So politicians increasingly are declaring war on common remedies. (Next maybe campaigns against other products, such as brake fluid and rubbing alcohol, also used inmeth production.)
States increasingly penalize anyone with the sniffles. At least 30 states limit the amount ofover‐the‐counter medicine consumers can purchase, restrict the number of pills perpackage, 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 pharmacycounter. Buyers are allowed to buy only limited quanities, must show an ID, and sign anofficial 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 Committeeapproved 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 JosephMcNamara 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 pseudoephedrinesmuggled in bulk from either Canada or Mexico.
Indeed, the recent U.S. crackdown has pushed production south of the border where alreadyoverwhelmed authorities are ill‐prepared to respond. And given how ineffective Washingtonhas been at interdicting other drug shipments, drug traffickers will likely bring in more thanenough meth to satisfy willing customers.
However, new regulatory restrictions will greatly inconvenience anyone who gets sick. Goingto a doctor for a prescription is time‐wasting and expensive.
Limiting purchases to a pharmacy or behind the counter is a particular bother, especially foranyone in a rural area or who gets sick at night. Even people near big stores would have towait 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. Druggistswould have to check IDs and maintain logs for cold pills rather than worry about misuse ofreal prescription drugs — including possible dangerous interactions with other medicines.
Retailers and sellers have responded in an attempt to preempt regulation. Some stores nowlimit quantities of pseudoephedrine‐ based medicines that can be purchased and theConsumer Healthcare Products Association, representing the over‐the‐counter industry, hasproposed 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 ingredientthat 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 runnew medicines and even new combinations of old medicines through the usual regulatorygamut, penalize improvements.
The agency has expedited review of medicines with potentially life‐saving uses. The FDAshould apply the same principle to more mundane products, in this case directed at thecommon cold.
Firms should be encouraged to use phenylephrine, reformulate existing combinationproducts, and develop new remedies with the promise that the FDA will help speed resultingmedications to market.
There’s no need to compromise safety — which wouldn’t be in the interest of producerseither. But FDA review should be simple and swift, lest the public be forced to rely oninferior, older products. Certainly the market should be left to determine which form ofmedicine is most effective.
For years unnecessarily intrusive agency regulation has delayed patient access to a host ofimportant medications, harming health and costing lives. Today FDA regulation inhibits drugdevelopments that could allow enhanced meth abuse enforcement without undulyinconveniencing the sick.
The meth crisis will eventually pass. In the meantime, government should stop treatingpeople with the sniffles as if they were meth abusers.