NABP Testifies at US Senate Hearning on Internet Pharmacies

NABP Executive Director/Secretary Carmen A. Catizone briefed the US Senate's Committee on Health, Education, Labor, and Pensions on the status of Internet pharmacies, the Association's research into online pharmacies, and the benefits provided to the public by NABP's Verified Internet Pharmacy Practice Sites^TM (VIPPS^TM) program. Catizone expressed NABP's position that VIPPS certification, combined with the regulatory authority of the state boards of pharmacy and enforcement actions of the Food and Drug Administration (FDA), provide the necessary safeguards to protect the public health.

The Committee's hearing, "E-drugs: Who Regulates Internet Pharmacies?" was held March 21 to gather information prior to any federal regulation decisions concerning Internet pharmacy sites. The purpose of the hearing, according to Senator James M. Jeffords (R-VT), chairman, was to give members an "overview of the advantages and dangers of purchasing pharmacy products over the Internet, as well as a picture of what we can and should be doing to protect Americans from these dangers." Also attending the hearing was Senator Edward M. Kennedy (D-MA) and Senator Christopher Dodd (D-CT). Witnesses were divided into two panels. The first panel was comprised of representatives from the FDA, while the second panel was composed of state government, association, and consumer representatives.

Catizone testified NABP supports cooperative efforts between state and federal governments, but emphasized NABP's and the state boards of pharmacy's opposition to any federal preemption of the states' authority to regulate the practice of pharmacy. By way of example, he pointed to the Prescription Drug Marketing Act of 1987, which included certain provisions and standards at both the state and federal levels that were coordinated through the US Food and Drug Administration (FDA) and state boards of pharmacy. Catizone also requested additional resources on behalf of the states to curb the illegal activities of Internet sites, such as funding for additional investigators and access to informational databases maintained by federal agencies monitoring and investigating the Web.

This testimony follows NABP's earlier testimony before the US House of Representatives Commerce Committee Subcommittee on Oversight and Investigations. In his presentation to the Senate, Catizone testified that since the Commerce Committee hearing, NABP has noted some changes in Internet pharmacy sites. On the positive side, VIPPS certifications have been awarded to five online pharmacies, offering additional benefits to patients. He also reported some illegal sites have attempted to improve their appearances in order to present a professional and trustworthy appearance. This is where a great deal of the danger lies, he testified.

NABP staff has divided online pharmacies into two major categories, legal and illegal sites. An illegal site is defined as one that makes prescription medicines available to patients without a valid patient-physician relationship, or is in violation of existing federal or state laws or regulations. Illegal online pharmacies fall into the categories of prescription optional, questionnaire sites, cyberspace consultations, prescriber-based sites, and referral sites.

Legal Internet sites are divided into seven subcategories: information sites, over-the-counter reference sites, alternative medicine sites, pharmacy sites, transmission or relay sites, wholesaler sites, and veterinary sites.

In order to assist member boards in identifying and prosecuting these unscrupulous sites, NABP has worked closely with state medical boards, the Federation of State Medical Boards, federal agencies, pharmacy and allied health care associations, and other regulating entities to create the infrastructure for an effective strike force to combat US-based pharmacy sites that present harm and danger to the public health.

NABP's VIPPS program combines the mandatory requirements of state regulation with specially designed Internet practice criteria developed by an expert panel of state and federal regulators, consumers, providers, and practitioners. Since the first VIPPS seals were awarded in September 1999, news of the VIPPS program has reached approximately 200 million consumers through media exposure.

In her testimony before the committee, FDA Commissioner Jane E. Henney stated the FDA's position on Internet pharmacy regulation is that online pharmacies should be licensed and operated under the same regulatory system that Congress and the states have instituted for traditional "brick-and-mortar" pharmacies. She also discussed FDA's request for $10 million in the president's Fiscal Year 2001 budget to enhance the agency's enforcement capabilities.

Other witnesses at the hearing included Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, and John Taylor, senior advisor for regulatory policy of FDA's Office of Regulatory Affairs; Carla J. Stovall, Kansas attorney general; Bruce Levy, executive director, Texas State Board of Medical Examiners; Peter Neupert, president and CEO, drugstore.com; and Calvin J. Anthony, executive vice president, National Community Pharmacists Association (NCPA).

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