GAO Internet Rx Study Should Include Role Of Credit Cards – Rep. Dingell

The sale of prescription drugs over the Internet could be prevented if credit card companies monitored the websites that use their services, House Energy & Commerce Committee Ranking Member John Dingell (D-Mich.) suggests in a Nov. 13 letter to GAO.

The potential role of credit card companies in policing Internet sites that sell prescription drugs is one area for which Dingell is requesting further study by the Government Accounting Office.

"What role do the major credit card companies (such as Visa and MasterCard) and underwriting banks play in selling dangerous drugs - such as controlled substances - via the Internet?" Dingell asks. "Are they self-policing the websites to which they are offering their services? If not, should they be required to do so?"

Holding credit card companies accountable for the sale of Rx drugs over the Internet has also been advocated by the National Association of Chain Drug Stores.

NACDS sent a letter to credit card companies earlier this year informing them that if their cards are used by Americans to purchase foreign drugs, the companies could be held liable for aiding and abetting illegal activity (¹ (Also see "NACDS Medicare Rx Principles: Protect Pharmacies From Insurers’ Risk" - Pink Sheet, 5 May, 2003.), p. 4).

Dingell's request to GAO was issued in response to increasing frustration over the reimportation issue. Commerce subcommittees have held numerous hearings on the topic, most recently this summer (² (Also see "Reimportation Vote Planned In House; Advocates Say Must Be In Medicare" - Pink Sheet, 30 Jun, 2003.), p. 26).

A reimportation measure is being discussed as part of the Medicare reform conference bill (³ 'The Pink Sheet' Nov. 3, 2003, p. 31). Any measure will likely include a provision that HHS certify the safety of reimported drugs. On FDA's advice, Secretary Thompson has previously declined to implement the law on that point.

Dingell's GAO request closely follows an Oct. 20 letter to FDA, the Drug Enforcement Administration and U.S. Customs & Border Protection that raised concerns about the "ease of entry of controlled substances" into the U.S. through international mail facilities (⁴ (Also see "Mass. Legislators Urge FDA To Create Plan To Ensure Rx Import Safety" - Pink Sheet, 27 Oct, 2003.), p. 11).

Some of the concerns Dingell raised in that letter also will be topics for GAO study.

For example, Dingell asked the agencies what specific plans are in place to "coordinate and address the problem of the many Internet sites that purportedly appear to be both advertising and shipping illegal controlled substances into the U.S. via Federal Express, United Parcel Service?" Dingell asks GAO to study the same issue.

The Michigan Democrat also requests that GAO study the pace at which the "quantity of unregulated dangerous drugs entering the U.S. via mail and mail-related channels" is growing, and whether FDA, DEA and Customs are "collecting meaningful data" on the issue.

Mail branch facilities "routinely find controlled substances, and in ever-increasing numbers," the letter maintains. For example, during a recent visit to a Miami mail facility, committee staff "witnessed several bins containing thousands of shipments of diazepam."

GAO will also study whether FDA or Customs are able to modify their screening procedures at mail facilities.

Do "FDA or Customs have the ability to change "internal 'processing' procedures with respect to personal (or small) shipments of controlled substances (Schedules II-V) entering the U.S. via the U.S. mail and the major consignment carriers?" Dingell asks.

FDA instructs Customs to "examine and detain only the 'large' parcels that appear to contain drugs," the letter says. "Yet FDA field staff had no definition of what a large package was, nor was it clear why the smaller packages were somehow viewed as safe as they routinely left the facility with no examination."

"Moreover, because FDA's detention process now takes approximately two hours to detain even a single package, it is unrealistic to believe this system has any material application as thousands of shipments are entering this (and other) facilities each day."

"FDA's instructions and processing procedures have become meaningless in the field. They are vague, devoid of reality, and cannot be expected to serve as the regulatory tool of any consequence," the letter says.

FDA and Customs have been discussing revising screening guidelines for drug imports based on the results of a pilot program in Carson City, Calif. (⁵ (Also see "Imported Drugs Screening Guidelines Under Revision By Customs And FDA" - Pink Sheet, 15 Jul, 2002.), p. 23).