July 1, 1999

Mr. Carmen Catizone
Executive Director
National Association of Boards of Pharmacy
700 Busse Highway
Park Ridge, Illinois 60068

Dear Mr. Catizone:

The Committee on Commerce has been investigating a number of issues pertaining to the sale of pharmaceutical products over the Internet. Committee staff have met with the Food and Drug Administration (FDA), Department of Justice (DOJ), Federal Trade Commission (FTC), and several state agencies involved in the regulation and sale of pharmaceuticals. These meetings have attempted to determine: (1) the extent of this problem, (2) the jurisdiction of each agency involved and the activities now being undertaken by each in this matter, and (3) specific changes to current law (if any) that might be needed to address this problem.

As you are well aware, pharmacies are regulated by state boards of pharmacies which work in conjunction with the appropriate state agencies to ensure that operating pharmacies are properly licensed and exercise suitable controls and practices over the distribution of pharmaceutical products. Although oversight of these "brick and mortar" pharmacies has been a relatively straightforward process, the emergence of Internet pharmacies poses significant challenges to the existing system. Online drug sites can now be located in almost any state or country having phone lines, yet easily sell to consumers anywhere in the U.S. market. To complicate matters further, some online pharmacies may not have a single location for a state to regulate, but may be located across several states or jurisdictions. For example, an online pharmacy might place its computers and offices in one state, its prescribing doctor(s) in another, and the actual pharmacy filling the prescriptions in a third state, all while the purchaser resides in a fourth state. Clearly, this situation creates significant challenges and risks for both regulators and consumers.

In response to public concern about the safety of these sites, the National Association of Boards of Pharmacy (NABP) has developed the Verified Internet Pharmacy Practice Sites (VIPPS) program. Essentially a "Good Housekeeping" seal of approval, this program is designed to provide site users some assurance that a pharmaceutical site has received at least some scrutiny and meets certain standards. As NABP’s Web site indicates, VIPPS pharmacy sites are identified by the VIPPS hyperlink seal displayed on each site’s main page. By clicking on the seal, a visitor is linked to the NABP VIPPS site where verified information about the pharmacy is maintained by NABP.

While we agree that this is a laudable first step to the challenges posed by Internet drug sites, a host of problems still exist, and will probably continue to exist even after the VIPPS program is in place. For example, most sites now operate without any VIPPS seal, and it is unclear when or if the public will ultimately understand what the VIPPS does, or make purchasing decisions because of it. Moreover, some individuals appear to gravitate to fringe sites because of the very activities the VIPPS program is trying to prevent (e.g., the site doesn’t require a prescription or the site requires only a dubious online consultation). Because VIPPS is a voluntary program, it is unclear how such an effort would ever address many of these unlicensed fringe sites. Finally, because NABP is not a regulatory authority, it is not clear to us whether NABP will have the resources to provide adequate scrutiny or review of all VIPPS-candidate sites or how it will enforce sanctions against any VIPPS operators should they later engage in bad practices.

Given the rapidly expanding nature of online pharmacies and the significant challenges they are presenting to both state and federal regulators, we are interested in knowing more about what NABP is doing generally about online pharmacies, and particularly more about the VIPPS program. Accordingly, we would appreciate it if your organization could respond to the following questions:

(1) Please describe the NABP standards that an online pharmacy must meet and maintain in order to acquire and keep a VIPPS accreditation.

(2) Please describe the steps each online pharmacy must go through to get a VIPPS accreditation, including: (a) the documents that must be filled out or the types of documents that must be submitted; (b) the components of a company that will be inspected by NABP and what such an inspection will entail; (c) the persons (and qualifications of the persons) conducting such inspections, and (d) the average cost expected for each inspection. Please also include your estimate of the average amount of time the entire application/inspection process will require.

(3) How many online drug sites does NABP currently believe are licensed by any State Board of Pharmacy? How many online sites does NABP estimate are currently selling prescription drugs to U.S. consumers without a license?

(4) How many online pharmacies have applied to the NABP for VIPPS accreditation and how many have you now inspected? Of such applicants, what kinds of VIPPS non-compliance issues has the NABP identified?

(5) Once an online site qualifies for a VIPPS seal, how often will NABP reinspect the site to determine if the Internet site is operating in a manner consistent with the NABP’s original requirements? Further, since NABP is not a regulatory body, if a site deviates from NABP’s requirements, what actions can or will NABP take to bring the site back into compliance? If a site disagrees with the NABP regarding any aspect of compliance, is there a resolution process? If a disagreement between a site and the NABP persists (e.g. the site remains non-compliant with NABP guidelines), will information about the site be provided to either state or federal regulators?

(6) Please provide a listing of the agencies and organizations that participated in developing the VIPPS program. Please also describe each agency or organization’s role in this regard.

(7) Please describe how the individual State Boards of Pharmacy will prepare for this program. Does NABP believe they currently have the trained personnel and finances to implement this program on a state-by-state basis? If not, how long will it take to have such requirements in place?

(8) Will individual medical record privacy be included in the standards developed for accreditation by the VIPPS program? If so, please describe how this will be implemented and enforced.

(9) In cases where sites are offering prescription drugs without a license, what does NABP believe to be the source(s) of such drugs? E.g, are they possibly counterfeit? Are they possibly authentic drugs, but diverted from foreign or other sources? Please explain.

(10) Does the NABP believe there may be threats with hackers stealing the VIPPS seal and placing it on an unapproved site? What will prevent unscrupulous sites from fraudulently linking to the NABP web site or to a dummy site that attests that the web site is accredited under the VIPPS system? How secure will the actual NABP’s VIPPS certification database be from outside infiltration by hackers? Are there other related problems you foresee in this area?

(11) When an individual links to the NABP web site through a VIPPS certification seal what exactly will the potential buyer discover? For example, will the user arrive directly at an information screen regarding the particular online web site they linked from, or will it be a general site from which they must search for information about the site in question?

(12) Will NABP be developing any efforts to educate consumers about the VIPPS program and the potential dangers of ordering pharmaceuticals over the Internet? Specifically, for example, how will a user know that a VIPPS certification seal makes an online pharmacy legitimate?

(13) Does NABP have a position on the suitability of so called "online consultations" where a doctor actually "reviews" patient information and then determines through this consultation if the patient should receive a prescription? Does the NABP have specific guidelines/criteria/standards for this type of site?

(14) If so, what guidelines/criteria/standards will you use to prove that there is a "meaningful consultation between a patient and a pharmacists"?

(15) Does the NABP have a position on how doctors’ prescriptions should be handled in regard to online pharmacies? For example, what form of communication for a prescription does NABP find acceptable: mail, phone, fax, email, other? How will the authenticity of prescriptions under any of the NABP-approved communication methods be verified?

(16) Does the NABP perceive it as one of the functions of the State Boards of Pharmacy to seek out online pharmacies within the boundaries of their State? If so, how will the Boards carry out this task and what kind of action can they or will they take upon uncertified online pharmacies? If not, whose role is it to find online pharmacy web sites within a State’s boundaries?

(17) Finally, how does NABP believe that the U.S. consumer should be protected from foreign online pharmacy sites?

Thank you for your cooperation and attention to our request. We look forward to continuing working with the NABP on these important consumer protection and public health issues. If you have any additional questions about this matter, please have your staff contact Mr. Christopher Knauer of the Commerce Committee minority staff at (202) 226-3400.

Sincerely,

JOHN D. DINGELL
RANKING MEMBER
COMMITTEE ON COMMERCE

RON KLINK
RANKING MEMBER
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

Prepared by the Democratic staff of the Commerce Committee
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