July 24, 2000

Mr. Alan Holmer
President
Pharmaceutical Research and
Manufacturers of America
1100 15th Street, N.W., Suite 900
Washington, D.C. 20005

Dear Mr. Holmer:

Recently, several legislative proposals changing the Prescription Drug Marketing Act (PDMA) have been presented in Congress. They would make it easier for U.S. citizens to attain drugs from foreign sources, which could increase the likelihood of counterfeit, misbranded, or adulterated drugs entering the United States. We note your full-page ads in the Washington Post in response to these initiatives, warning consumers about the dangers counterfeit drugs could pose. But the threat of misbranded and potentially counterfeit drugs entering the U.S. from foreign sources is already a problem, which your industry has been curiously slow to address.

For the past several years, the Committee on Commerce has been investigating a variety of issues relating to Web sites selling drugs on-line. Many of these now operate from abroad, will sell drugs to almost anybody with a valid credit card, yet most receive almost no regulatory scrutiny. Many do not require interaction with a licensed practitioner, yet will dispense often powerful medications to a consumer’s doorstep at the click of a mouse. These drugs are often sent without clear usage instructions, proof of authenticity, or even something as fundamental as an expiration date.

The U.S. Customs Service reports it is now overwhelmed by this problem. Last year alone, the agency experienced a more than 400 percent increase in prescription drugs being sent from foreign sources into the U.S. via the mail. As noted in a May 22 letter from Commissioner Kelly addressed to both of us regarding these drugs, "In most of the mail seizures that Customs encounters, the brand name and manufacturer of the products are not identifiable because the original packaging has been removed and repacked into containers that bear no marks or identification."

In sum, a major problem exists, regardless of what new legislation may be enacted. As Commissioner Kessler recently wrote,

"In my view, the dangers of allowing re-importation of prescription drugs may be even greater today than they were in 1986. For example, with the rise of Internet Pharmacies, the opportunities for illicit distribution of adulterated and counterfeit products have grown well beyond those available in prior years."

What is now occurring through these on-line pharmacies is similar to the mislabeling and repackaging schemes that ultimately led to the PDMA. Moreover, what is also occurring via these Internet sites is what PhRMA claims the recently passed legislation would create. Yet, both PhRMA and your member drug companies have remained oddly silent on the on-line pharmacy problem.

Others have sought to address this problem. Aside from the several public hearings both House and Senate Committees have held on this matter (in which numerous policy proposals were discussed), legislative proposals have been drafted in both the House and Senate, and even proposed by the Administration. In addition to legislation, other proposals have been made. Just last May, during the most recent hearing on this matter, Congressman Klink made a specific request to those drug companies with major promotional Web sites (see Viagra.com, Xenical.com, and Propecia.com, as examples) that they provide either a link to the Food and Drug Administration’s site where a discussion on the potential dangers of buying drugs on-line can be found, or that the companies provide their own warning. Such a measure would contribute directly to consumer safety, and would cost little to implement. Yet at the time of this letter, no action (from at least the above sites) appears to have been taken. Moreover, PhRMA’s own Web site -- which has an abundance of articles on a variety of subjects -- also seems to lack a section warning consumers of these dangers.

Your organization’s credibility on these matters would be greatly enhanced by prompt and aggressive action against current threats. It is our understanding that your staff has recently agreed that PhRMA would "begin to focus on this matter." More is needed. As the problem of drug counterfeiting is still with us, and as the use and availability of the Internet continues to spread, the problem of misbranded and potentially very dangerous drugs entering this country from abroad will only worsen.

Sincerely,