December 15, 2005
Restrictions on Meth Ingredients Are Sought
By GARDINER HARRIS
WASHINGTON, Dec. 14 - A bipartisan group of lawmakers announced an agreement on Wednesday to restrict the sales of cold medicines that can be used to manufacture the illegal and highly addictive drug methamphetamine.
Under the proposal, Sudafed and similar medicines would have to be under lock and key in stores. Buyers would have to sign a sheet and show a driver's license. Purchases would be limited to one box a day and three boxes a month.
The legislation is attached to the renewal of the USA Patriot Act, which passed in the House on Wednesday but whose prospects in the Senate are uncertain.
Thirty-four states have enacted similar restrictions, and these sorts of controls have long been advocated by officials of the Drug Enforcement Administration, who argue that controlling the supply of the medications is the best way to reduce abuse.
But officials at the Food and Drug Administration have quietly fought such proposals, arguing that most methamphetamine is imported and that restricting cold medicines would lead to unneeded suffering among patients in need.
The fight, pitting government law enforcers against drug regulators, extends beyond cold medicines to steroids and painkillers.
On Wednesday, the enforcers won a crucial battle. Representative Mark Souder, Republican of Indiana and sponsor of the methamphetamine legislation, said the F.D.A. was wrong. "Yes, consumers will have less choice," Mr. Souder said, "but it will have a minimal effect on sinus relief and pain relief."
Dan Troy, former general counsel of the food and drug agency, countered that cold sufferers would have a harder time getting relief as a result of the legislation. "I think it's very sad when you punish the good and the needy because of a few bad actors," Mr. Troy said.
A casual poll of a handful of internal medicine doctors who routinely treat cold sufferers found unanimous agreement that the legislation was needed.
"The restrictions on Sudafed, although somewhat onerous, aren't that bad," Dr. William Schreiber, an internist in Louisville, Ky., where such restrictions are already in place, said, adding, "anything that goes about limiting the production of meth probably has to be done."
Dr. Mary Klotman, chief of infectious diseases at the Mount Sinai School of Medicine in Manhattan, called the restrictions "reasonable."
"I don't think anyone should stockpile these medicines," Dr. Klotman said.
Officials of the two federal agencies would not speak for attribution about the dispute between them. But Rogene Waite, a spokeswoman for the Drug Enforcement Administration, said the legislation would "help the D.E.A. force more methamphetamine traffickers out of business."
Kristen Neese, a spokeswoman for the Food and Drug Administration, said, "We are concerned about the problems of abuse and are committed to finding the right balance between access and safety."
But the battle between the agencies was confirmed by legislators and others. "That's true," said Senator Jim Talent, Republican of Missouri, adding that officials of the food and drug agency "were not able to come together and support our bill, which was very frustrating to me."
An official at the Drug Enforcement Administration appeared at the legislative announcement in the House, and more than a dozen representatives of law enforcement and the judiciary appeared for the Senate announcement. No public health officials appeared at either event.
The legislation is intended to reverse a growing epidemic of methamphetamine abuse that started a decade ago on the West Coast and has gradually spread East. There are an estimated 1.4 million methamphetamine abusers in the United States, many in rural communities.
The drug's arrival in small towns often leads to crime sprees and crowded jails. A recent survey of 500 local law enforcement officials found methamphetamine to be their No. 1 concern. Methamphetamine can be manufactured in kitchens using hundreds of pills containing pseudoephedrine or ephedrine, decongestant ingredients in Sudafed and other over-the-counter cold and flu treatments.
Americans suffer an estimated one billion colds each year. There is no cure, but Sudafed and similar drugs offer safe and effective palliative treatment. Sales of pseudoephedrine products topped $580 million in 2004 and have not grown appreciably in recent years, suggesting that any diversion of the product for methamphetamine production is a relatively small part of overall sales.
Sudafed and similar medicines are widely sold in convenience stores and pharmacies. The new legislation will probably mean that far fewer stores will offer the drugs, said Steve Francesco, an expert in over-the-counter drug marketing.
"Most stores are not structured" to have products under lock and key, Mr. Francesco said. "This bill is a disaster for anyone with a cold."
The methamphetamine legislation creates a new class of "behind the counter" drugs in the United States. Many European countries have this class of medicines, and the creation of such a class in this country has long been debated. But the Food and Drug Administration has argued that it does not have the power to mandate such sales or to enforce the restrictions.
Indeed, the agency recently rejected a proposal to allow the sales of an emergency contraceptive, known as Plan B, as a "behind-the-counter" drug for precisely these reasons. Some agency observers suggested that the methamphetamine legislation might make it easier for the agency to approve the emergency contraceptive application.
"This could make Plan B more palatable," said Dr. Eric Brass, a professor of medicine at the David Geffen School of Medicine at the University of California, Los Angeles.
A 1995 Congressional study of "behind the counter" programs in 10 other countries found that these programs provided few protections and failed to reduce access to the medicines in the programs significantly. Some states have found, however, that restricting access to cold medicines leads to a sharp drop in the number of methamphetamine laboratories discovered by law enforcement officials. Whether these laws also result in reduced use of the drug is not known, several legislators said.
Backers of the methamphetamine provision say that should the Patriot Act fail to pass this year, they will attach it to another piece of legislation.