July 14, 2000

The Honorable Jane E. Henney, M.D.
Commissioner
Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857

Dear Dr. Henney:

Recently, the House of Representatives adopted two amendments, one by Rep. Crowley (D-NY) and one by Rep. Coburn (R-OK), to the Agricultural Appropriations bill which could have a profound effect on how the Food and Drug Administration (FDA) protects consumers from imported prescription drugs of uncertain safety and effectiveness. I am concerned that these amendments could seriously undermine the Prescription Drug Marketing Act (PDMA), and thus adversely affect public health.

During the 1980's, the House Energy and Commerce Committee conducted a lengthy investigation into the foreign drug market that ultimately led to enactment of the PDMA. That investigation discovered a potentially dangerous diversion market that prevented effective control over the true sources of merchandise in a significant number of cases. The integrity of the distribution system was found to be insufficient to prevent the introduction and eventual retail sale of substandard, ineffective, or even counterfeit pharmaceuticals. As the resulting Committee report stated, "pharmaceuticals which have been mislabeled, misbranded, improperly stored or shipped, have exceeded their expiration dates, or are bald counterfeits are injected into the national distribution system for ultimate sale to consumers."

The PDMA was designed to restore the integrity and control over the pharmaceutical market necessary to eliminate both the actual and potential health and safety problems before injury to the consumer could occur. Again, the Committee report was clear on why the PDMA was needed:

"[R]eimported pharmaceuticals threaten the public health in two ways. First, foreign counterfeits, falsely described as reimported U.S. produced drugs, have entered the distribution system. Second, proper storage and handling of legitimate pharmaceuticals cannot be guaranteed by U.S. law once the drugs have left the boundaries of the United States."

Alarmingly, I find little now that suggests that the problem with misbranded, adulterated, or even counterfeit foreign drugs has been solved. I reiterated these concerns with respect to the Crowley and Coburn amendments (see enclosed remarks). In fact, the evidence suggests the problem is getting worse. I am concerned that in our haste to find a way to bring cheaper drugs to seniors and other needy Americans – a clearly important and laudable goal – we risk making changes to key health and safety laws we may later regret. I am thus requesting that you quickly provide me with the following information:

(1)  Please provide a detailed analysis on how (H.R. 4461 and H.R. 3240) would affect FDA's present operations regarding efforts to prevent misbranded or potentially dangerous drugs from entering the U.S. Specifically, please provide:

(a) a description of how the present system now used by FDA works;
(b) what the present system is intended to accomplish; and
(c) what changes would be required (and the potential effects of those changes) if this legislation passes in its present form.

Please include a discussion of how these amendments would affect the activities of other agencies, such as the U.S. Customs Service, with responsibilities for assuring the safety of imported prescription drugs.

(2)  Please determine if either of these amendments would have any effect on FDA's ability to enforce good manufacturing practices (GMPs) in any foreign firms that ship drugs to the U.S. If so, please explain any potential effect on consumer health and safety.

(3)  Please provide a full description regarding what a "warning letter" is and how it is typically used by the FDA. Please compare this with correspondence that is sent by Customs.

(4)  It appears that these amendments would directly affect the ability of FDA to send warning letters to consumers that purchase drugs over the Internet. As you know, some web sites appear to be covertly linked to foreign drug suppliers. When a consumer orders from such a site, it is not always obvious that they are dealing with an offshore supplier, and thus a potentially non-FDA approved facility. Often, warning letters may be the only indication that the Internet-ordered drugs originated from a foreign (and potentially dubious) source. Please indicate how this legislation could affect FDA's ability to protect consumers who purchased drugs in this way.

(5)  Please detail any other potential effects this legislation could have on FDA’s ability to protect consumers from potentially dangerous drugs that originate abroad.

(6)  Finally, please provide technical assistance in the form of specific suggestions for legislative or regulatory changes that would be needed in order to facilitate the safe importation of prescription drugs by individuals, wholesalers, or retailers.

I would appreciate a full response to this letter by Friday, July 28, 2000. Please do not delay.

Sincerely,

JOHN D. DINGELL
RANKING MEMBER

Enclosures

cc: The Honorable Tom Bliley, Chairman
Committee on Commerce

The Honorable Donna E. Shalala, Secretary
Department of Health and Human Services