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12/7/2000

GAO Report Spurs Internet Pharmacy Regulation

Kate Traynor

A General Accounting Office (GAO) recommendation has prompted Congress to consider legislation that will amend the Federal Food, Drug, and Cosmetic Act so as to address the regulation of Internet pharmacies.

The GAO report (PDF) on Internet pharmacies was issued last October at the request of Rep. Henry A. Waxman, D-Calif., and members of the House Committee on Commerce. Just before official release of the GAO report, identical bills titled "Internet Prescription Drug Consumer Protection Act of 2000" were introduced in the House of Representatives and the Senate.

These bills address GAO’s recommendation to make Internet pharmacies comply with the state and federal laws regulating traditional pharmacies in the United States.

Pharmacies operating over the Internet, said GAO, offer a degree of anonymity not found in "brick and mortar" pharmacies. GAO noted that the information available at some of the Web sites operated by Internet pharmacies is insufficient to reveal whether the drugs offered for sale are both approved for use in the United States and properly dispensed.

The GAO report also described a very troubling practice of Internet pharmacies—the sale of prescription drugs to people without prescriptions. Also problematic, said the report, are Internet pharmacies that issue and fill prescriptions in response to answers consumers provide through an online questionnaire.

GAO recommended that U.S. pharmacies doing business over the Internet be required to disclose on their Web site who owns and operates the pharmacy and in what state the business is licensed. People responsible for prescribing medications online would also be required to disclose their names and licensing information.

In its report, GAO noted that Internet pharmacies, which operate across state and international boundaries, produce unique regulatory challenges. For example, the U.S. Customs Service inspects and may detain drug products received from foreign countries, preventing illegally imported material from reaching consumers. However, GAO found that the Food and Drug Administration (FDA) often instructs the Customs Service to release these small packages.

FDA, said the GAO report, has pledged to better coordinate with the Customs Service in their oversight of drug products entering the United States.

According to a spokesperson for the Committee on Commerce, the Internet pharmacy bills introduced during the 106th session of Congress have strong bipartisan support and will likely be addressed during the upcoming legislative year. PDF versions of the full House and Senate bills are available online. ASHP's Government Affairs Division has prepared a summary of the proposed legislation.