Can We Regulate Overseas Pharmacies?

By Ronald L. Scott
Rscott@central.uh.edu

In a recent article titled You Can Get Anything You Want: Internet Pharmacies Overstep Boundaries, my colleague described efforts to regulate the sale of prescription drugs over the Internet. She also noted that the Internet is largely unregulated. Indeed, just as federal and state regulators step up efforts to control Internet sales by pharmacies in the U.S., international entrepreneurs are selling record amounts of drugs to customers in the U.S. via the Internet.

A similar threat exists for international and U.S. Internet sales. Patients turn to Internet pharmacies based here and abroad to obtain drugs more cheaply, or to obtain drugs such as Viagra that some patients find too embarrassing to seek from their personal physicians. However, the international sales add, or at least exacerbate, the problem of patients obtaining illicit substances, i.e. drugs not approved as "safe and effective" by the U.S. Food and Drug Administration. Also, prescriptions may be obtained without adequate evaluation by qualified health professionals, and there is an increased potential that products sold may not meet FDA quality standards. (The Prescription Drug Marketing Act, passed by Congress in 1988, prohibits the importation back into the U.S. of any drug earlier exported, unless the drug has at all times remained under the control of the manufacturer.)

In July 1999, Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, testified before the Subcommittee on Oversight and Investigations, Committee on Commerce, U.S. House of Representatives. Based partly on the Clinton Administration’s July 1, 1997 Framework for Global Electronic Commerce and the President’s November 30, 1998 Memorandum on Successes and Further Work on Electronic Commerce, she reiterated the following principles that apply to prescription drug sales on the Internet:

Dr. Woodcock's testimony is available at http://www.usembassy.ro/USIS/Washington-File/100/99-08-02/eur118.htm.

Effective enforcement and regulation requires cooperation among all domestic and foreign regulating bodies because Internet commerce crosses state, national and international boundaries. Last year, U.S. Customs inspectors seized 9,725 packages containing prescription drugs—up from 2,148 in 1998. Seized drugs included steroids, hormones, aphrodisiacs, impotency medications, anticancer drugs, painkillers and tranquilizers. The drugs were sent from locations in the Asia-Pacific region, Europe, Central American, and elsewhere.

Politically, the issue of restricting international sales is sensitive since some politicians have criticized pharmaceutical companies for charging higher prices in the U.S. than in other countries. Some patients are simply taking advantage of "gray-market" importing to save money on legitimate prescriptions. Practically, effective regulation is nearly impossible. The U.S. could step up customs enforcement actions in the U.S.—but such action is analogous to going after the small user rather than the kingpin-distributor in the "war on drugs." The U.S. government can probably count on some regulatory support from countries such as England that regulate prescription drugs as rigorously as the U.S. However, it would be surprising for countries that allow the sale of most drugs without prescription to offer assistance with enforcement of more stringent U.S. standards, especially since such enforcement would negatively affect the economy and citizens of the country where the sales occur. At present, the best advice is caveat emptor, let the buyer beware.

01/20/00