October 11, 2000
By ROBERT PEAR
WASHINGTON, Oct. 10 - Doubts are growing about legislation to allow imports of low-priced prescription drugs, and no one in the government or the drug industry can say how it will work, or even whether it will work.
House and Senate negotiators approved the measure on drug imports last week. But Chris Jennings, the health policy coordinator at the White House, said today, "As currently structured, this provision is unworkable and would not achieve its goal."
A lobbyist for one of the nation's biggest drug companies, which have worked against the measure, said, "I doubt that anyone will realize a penny of savings from this legislation."
The purpose of the legislation is to help Americans gain access to prescription drugs at the lower prices charged in foreign countries that regulate drug prices. The bill would allow pharmacists and wholesalers to import prescription drugs that meet safety standards set by federal law and regulations.
The measure, included in a bill to provide money for the Agriculture Department, was not thoroughly examined or approved by the congressional committees that normally handle health legislation.
Republicans and some Democrats pushed the drug legislation as a roundabout way to address voters' concerns about high drug prices. Members of Congress did not want to control drug prices directly, and they have been unable to agree on legislation to add drug benefits to Medicare, the insurance program for the elderly and disabled.
Even some original supporters of drug-import legislation, like Senator Byron L. Dorgan of North Dakota and Representative Marion Berry of Arkansas, both Democrats, said they were disappointed with the compromise. "I don't think consumers will get much benefit," Mr. Berry, a pharmacist, said in an interview.
The Food and Drug Administration initially expressed grave reservations about efforts to relax restrictions on drug imports, saying such changes could endanger the safety of consumers. The Clinton administration later acquiesced in a version of the bill passed by the Senate, but President Clinton has not said whether he would sign the measure that emerged last week from a conference committee of the House and the Senate.
To put the bill into operation, the government would have to solve many legal, financial and logistical problems.
The F.D.A. said it would need $23 million to carry out its new responsibilities, and Congress provided that amount - but only for the first year.
Confidential budget documents show that the F.D.A. expects its costs will explode in later years. The agency says it will need 500 new employees and more than $90 million a year to test and regulate imported drugs when the program is in full swing. It is unlikely to get all those resources, lawmakers say.
The United States Customs Service will also have many new duties, but did not receive any new money. The agency says it is already struggling with a flood of prescription drug imports, including many counterfeit drug products, as Americans turn to the Internet to buy drugs from foreign suppliers.
In its budget documents, the Food and Drug Administration says it expects that "criminal activity will increase" under the legislation, so it will need $3.5 million a year for criminal investigations.
The legislation says that imported drugs must comply with all the safety and labeling requirements that apply to drugs made and distributed exclusively in the United States. Imported drugs will, in many cases, need to be relabeled.
Prilosec, a top-selling medication for ulcers and heartburn, is sold outside the United States as Losec, but that name is not approved for use on the drug in this country. In the United States, it is a purple capsule; in Canada, where the price is often much lower, it is sold as a tablet.
Foreign drug labels may be written in a foreign language, or may permit use of drugs for purposes not approved in the United States.
Dr. Jane E. Henney, the commissioner of food and drugs, said that "nothing in the bill requires a manufacturer to give the approved label to an importer," or to allow use of the label by an importer.
Representative Henry A. Waxman, Democrat of California, said: "The bill is full of loopholes. It tells U.S. pharmacists that they can import cheaper foreign drugs, but then denies them access to the F.D.A.- approved labels that must be on the drugs. The bottom line is that very few, if any drugs, can be imported into the United States under this legislation."
The bill says the changes in drug- import rules will take effect only if the secretary of health and human services can show that they pose no new risk to public health and safety.
Still, two senior members of the House, Thomas J. Bliley Jr., Republican of Virginia, and John D. Dingell, Democrat of Michigan, said the legislation increased the likelihood that counterfeit or adulterated drugs would enter the United States.
The National Wholesale Druggists' Association, which represents large wholesale distributors, opposed the legislation, citing concerns about safety.
But John M. Rector, senior vice president of the National Community
Pharmacists Association, which represents 35,000 independent pharmacies,
said some of his members were interested in importing prescription drugs
for their customers. The pharmacists, he said, will work through their
buying groups or purchasing cooperatives.