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Fri 31 Oct, 2003 08:33 am
Lawmakers Are Negotiating Import of Prescription Drugs
By ROBERT PEAR
Published: October 31, 2003
[]WASHINGTON, Oct. 30 — House and Senate negotiators say they are seriously discussing proposals to allow imports of less expensive prescription drugs from Canada, as well as a plan to give the Food and Drug Administration more money and more authority to police the market.
The negotiators have worked for more than three months on a bill to revamp Medicare and to add drug benefits to the program. But until this week, they largely avoided the explosive issue of drug imports.
Lawmakers said they discussed it on Wednesday night and again on Thursday at meetings with Tommy G. Thompson, the secretary of health and human services.
"We are considering it," said Representative Michael Bilirakis, Republican of Florida.
Millions of Americans have traveled to Canada and Mexico in search of low-cost medications. Many more have bought drugs from foreign suppliers by mail or the Internet.
The Bush administration and drug industry have opposed bills that would make it easier for pharmacists, wholesalers and individuals to import medicines. They say the legislation, endorsed in different forms earlier this year by the House and the Senate, could expose consumers to a flood of unsafe products.
Neither Mr. Thompson nor the White House signaled a change in the administration's position this week.
But Republican lawmakers and aides to Republican leaders in Congress said they had begun looking for ways to overcome the impasse, perhaps by allowing imports from Canada for a few years, under close federal supervision, to ensure that the drugs meet federal standards.
To address F.D.A. concerns, lawmakers said, they would provide the agency with resources to monitor and regulate the flow of imports. They could also subsidize development of new technology to thwart counterfeiters and to track drugs from the factory to the pharmacy.
Representative Jo Ann Emerson, Republican of Missouri, a supporter of imports, said that Medicare negotiators were "desperate to do something." While she would prefer a bill allowing imports from more countries, Mrs. Emerson said it would be feasible to start with Canada.
Members of Congress refused to discuss their deliberations in detail, so it is impossible to know exactly what they have in mind. But their comments suggested that the debate is shifting from the philosophical question of whether to allow more imports to the practical question of how to do so, in a way that minimizes the risks to public health.
In June, the Senate voted 62 to 28 for drug imports; in July, the House measure was approved 243 to 186. Given those votes, Republicans said, a final Medicare bill would probably need to ease imports in some way.
Of the 12 lawmakers shaping the final version of the Medicare bill, three voted for the proposals to ease drug imports: Senator Charles E. Grassley, Republican of Iowa; Senator Max Baucus, Democrat of Montana; and Representative Nancy L. Johnson, Republican of Connecticut.
Mr. Grassley said his position was long-held, "based on my support for free trade and my belief in maximum competition of the free enterprise system."
"Imports create competition and keep domestic industry more responsive to consumers," he said. "It's a fact of life that many constituents are going to Canada and Mexico. And it's something the American people want. I never have a town meeting where this issue doesn't come up."
Some conferees oppose any move to lift restrictions on drug imports. Senator Orrin G. Hatch, Republican of Utah, called it a bad idea, inspired by "populist politics." Representative Billy Tauzin, Republican of Louisiana, said it would be "a disaster to the health and safety of Americans."
Several Republican negotiators said they shared the drug industry's concerns but believed that its position was shortsighted and politically unsustainable.
Democrats say the risks of imports have been exaggerated by drug companies trying to protect profits. Some conservative House Republicans supported the measure as a way to promote open markets. But other conservatives opposed the bill, saying it would authorize the importation of foreign price controls along with cheap medicines.
Opposition to drug imports comes from political appointees and civil servants responsible for enforcing the nation's drug laws.
Peter J. Pitts, a spokesman for the F.D.A., said, "We have not been formally asked to provide technical assistance on any matters related to importation and are not discussing plans for any kind of compromise."
Another agency official said, "We won't negotiate until the 11th hour."
I find this another instance of congressional lunacy. They will not institute a system of controls similar to Canada. However, by allowing the importation of drugs from Canada at Canadian prices aren't they doing the same thing in surreptitious way.
Re: Lawmakers Are Negotiating Import of Prescription Drugs
au1929 wrote: I find this another instance of congressional lunacy. They will not institute a system of controls similar to Canada. However, by allowing the importation of drugs from Canada at Canadian prices aren't they doing the same thing in surreptitious way.
To a large extent that's true but there is also a possible back-lash danger in all of this. If the importing of drugs from Canada and/or Mexico is permitted both of those countries may find their drug prices skyrocketing. Drug manufacturers aren't going to take a loss. The Canadian gov can try to limit increases but if the makers are feeling the pinch they'll just pull their products out of the Canadian market entirely.
All of this will be an interesting side show to watch progress.
A Plan to Import Drugs Safely
Published: November 1, 2003
The state of Illinois has effectively skewered contentions by the federal Food and Drug Administration that it would be risky to import prescription drugs from Canada to save substantial sums of money. Indeed, an expert panel that visited Canada on behalf of the state has fashioned a plan that should actually make it safer for state employees to purchase drugs from Canada than in this country.
The notion of buying drugs from advanced nations where controls and government pressure help keep prices low has gained momentum as governors and mayors struggle with budget gaps that are fueled in part by escalating health care costs. Several states and New York City have expressed interest in importing drugs for their employees and retirees or for the health programs they sponsor. The obstacles have been a law banning such imports and safety concerns raised by the F.D.A. The agency worries that imported drugs may be stored or shipped improperly and that counterfeiters may slip in unsafe or ineffective drugs.
But the plan proposed by Illinois has so many safeguards that it looks more secure than the domestic drug-distribution system. To begin with, the list of drugs that could be imported would be restricted to those deemed clinically appropriate and unlikely to spoil in transit. Habit-forming pain medications would not be on the list, nor would antibiotics for acute illnesses. No patient would be allowed to import a drug until it had been prescribed by a doctor in Illinois and taken for at least a month. Then the order for that drug would be placed with a Canadian pharmacy or firm that was contractually obligated to supply only brand-name drugs, obtained from wholesalers that had gotten them directly from manufacturers in sealed packages that had not been opened along the way. Each patient would choose an Illinois pharmacist to coordinate all prescriptions to prevent harmful drug interactions, and Illinois laboratories would test the drugs.
The F.D.A. is rightly concerned about an increase in counterfeit drugs in this country and is leery that imports may exacerbate the problem. But the counterfeiting and adulteration have been fostered by Internet sales and by a complicated supply chain that offers criminals a chance to substitute bogus products. In Canada the supply chains are simpler and the drugs never repackaged.
Illinois seems unlikely to flout the law, but its proposal shows that safe importation is possible. A Congressional conference committee is considering legislation that would allow imports from Canada and possibly other advanced nations. The conferees should allow any state or city to sponsor an import program and should provide the F.D.A. with resources to set up and regulate a nationwide import system. As Mayor Michael Bloomberg said, this is "an idea whose time has come."