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Drug Re-Importation Law Aborted

Wed, 01/03/2001 - 12:00am — Karen Stevenson
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The Clinton administration killed a program created by Congress to allow imports of low-cost prescription drugs. The administration said the import plan would not be safe and would not save money for consumers. Donna E. Shalala, the secretary of health and human services, said the program was severely flawed. Even though President Clinton had previously questioned the feasibility of the program, expressing doubts even as he signed it into law, the timing of Dr. Shalala's finding was a surprise. The Clinton administration could easily have left the issue to President-elect George W. Bush, but instead invoked a provision of the law to abort the program.

In her letter, Dr. Shalala said the drug-import law had at least three "flaws and loopholes":

- Federal laws requires government-approved labeling on any prescription drug sold in this country, and drug makers could block imports of medications by denying importers access to those labels.

- Authority for the import program would have expired after five years. Wholesalers would have been reluctant to buy the equipment needed to test and distribute imported drugs because they could not be sure of ''long-term financial returns.''

- Drug makers could have thwarted the intent of Congress by requiring drug distributors to sell imported drugs at high prices.

The purpose of the measure was to help Americans gain access to prescription drugs at the lower prices charged in foreign countries that regulate drug prices. The law allowed pharmacists and wholesalers to import prescription drugs that meet federal safety standards. After working out details of the legislation in October, Congress at the last minute added a proviso saying that it would take effect only if the secretary of health and human services demonstrated to Congress that it would "pose no additional risk to the public's health and safety" and would "result in a significant reduction in the cost of covered products to the American consumer" and Dr. Shalala said she could not make either showing.

Individuals can still buy drugs from abroad. Consumers cross the border and buy medications in Canada or Mexico or buy drugs from foreign countries over the Internet. Federal officials have expressed concerns about both types of purchases, but they say that they generally do not challenge consumers importing small quantities of prescription drugs for personal use.

>> HR 4461

The Clinton administration killed a program created by Congress to allow imports of low-cost prescription drugs. The administration said the import plan would not be safe and would not save money for consumers. Donna E. Shalala, the secretary of health and human services, said the program was severely flawed. Even though President Clinton had previously questioned the feasibility of the program, expressing doubts even as he signed it into law, the timing of Dr. Shalala's finding was a surprise. The Clinton administration could easily have left the issue to President-elect George W. Bush, but instead invoked a provision of the law to abort the program.

In her letter, Dr. Shalala said the drug-import law had at least three "flaws and loopholes":

- Federal laws requires government-approved labeling on any prescription drug sold in this country, and drug makers could block imports of medications by denying importers access to those labels.

- Authority for the import program would have expired after five years. Wholesalers would have been reluctant to buy the equipment needed to test and distribute imported drugs because they could not be sure of ''long-term financial returns.''

- Drug makers could have thwarted the intent of Congress by requiring drug distributors to sell imported drugs at high prices.

The purpose of the measure was to help Americans gain access to prescription drugs at the lower prices charged in foreign countries that regulate drug prices. The law allowed pharmacists and wholesalers to import prescription drugs that meet federal safety standards. After working out details of the legislation in October, Congress at the last minute added a proviso saying that it would take effect only if the secretary of health and human services demonstrated to Congress that it would "pose no additional risk to the public's health and safety" and would "result in a significant reduction in the cost of covered products to the American consumer" and Dr. Shalala said she could not make either showing.

Individuals can still buy drugs from abroad. Consumers cross the border and buy medications in Canada or Mexico or buy drugs from foreign countries over the Internet. Federal officials have expressed concerns about both types of purchases, but they say that they generally do not challenge consumers importing small quantities of prescription drugs for personal use.

>> HR 4461