107th Congress

Continuting Concern Over Imported Pharmaceuticals --- Hearing Before the House Committee on Energy and Commerce --- Subcommittee on Oversight and Investigations --- June 7, 2001

Members Present

James Greenwood, Chair (R-PA); Peter Deutsch, Ranking Member (D-FL); Charles Bass (R-NH); Michael Bilirakis (R-FL); Richard Burr (R-NC); Diana DeGette (D-CO); John Dingell (D-MI); Steve Largent (R-OK); Cliff Stearns (R-FL); Bart Stupak (D-MI); Ed Whitfield (R-KY)

Panel One: The Reverend and Mrs. Edwin Rode, private citizens

Panel Two: Dr. Donald Vereen, Office of National Drug Control Policy (ONDCP); Ms. Laura Nagel, Drug Enforcement Administration (DEA); Ms. Elizabeth Durant, U.S. Customs Service; Mr. William Hubbard, Food and Drug Administration (FDA); Dr. Alan I. Leshner, Director, National Institute on Drug Abuse (NIDA), NIH; Landon Gibbs, First Sergeant, Virginia State Police

Panel Three: Dr. Marvin Shepherd, Professor, College of Pharmacy, University of Texas; Dr. John D. Glover, Vice President, Corporate Security, Bristol-Myers Squib; Mr. James Christian, Vice President and Head of Global Corporate Security, Novartis International AG; Mr. William Trundley, Vice President, Corporate Security and Investigations, GlaxoSmithKline; Mr. Gene R. Haislip, Leesburg, Virginia (former DEA official [headed drug diversion control office]); Mr. Donald DeKieffer, DeKieffer & Horgan

Summary

Purpose of Hearing

The Oversight and Investigation Subcommittee's hearing was centered on growing concerns that American consumers are not being given adequate protection by the federal government against unsafe pharmaceuticals being imported from abroad. Often these pharmaceuticals are of questionable quality and content and are apparently coming into this country through the mail service, frequently purchased over the internet without a prescription. In addition, federal policies that allow for personal importation at land-border crossings may be enabling individuals to bring in controlled substances for illicit purposes. The Subcommittee was interested in learning more about the coordinated efforts of the FDA, the DEA, and the U.S. Customs Service to limit the number of pharmaceuticals that come into this country under these circumstances.

Opening Statements

Representative Greenwood opened the hearing by describing the potential safety issues of buying medicines on-line without a prescription. He compared those selling drugs over the internet to "hucksters pedaling cures," since the products being bought are often counterfeit, adulterated, mislabeled or just plain dangerous. Representative Greenwood described shipments seized in the recent Operation Chokepoint that revealed that many of overseas pharmaceuticals purchased on-line are being manufactured in sub-standard facilities, including operations in rat-infested make-shift set-ups.

In his opening statement, Representative Deutsch complained that the Subcommittee had predicted this type of problem years ago as the internet boom began, and nothing had been done. Since then, Representative Deutsch reported, instead of a few dozen websites, there are now over one thousand websites offering prescription drugs. What is worse, said Deutsch, is that the latest research is showing that the recipients of these parcels without prescription were often young people.

Representative Dingell then gave his opening statement and decried what he called the misguided policies allowing these drugs to come into the U. S. from abroad. Thousands of packages, he said, are being released by the Customs Service without proper checks, due largely to the overwhelming volume of shipments. The Congressman then accused the FDA of "no leadership" on its own policies.

Statements of Witnesses and Questions

Dr. Vereen testified that ONDCP had recently begun co-ORDination of the federal agencies on pharmaceutical drugs and trans-border issues, that respects FDA, Customs and DEA's expertise in determining how to carry out agency internal policies. They are, however, working together on this complex issue that brings together regulations, statutes, practices, and research. Dr. Vareen said that the various interested federal agencies have held four recent meetings on the subject as they try to find a solution to the problem.

In her opening statement, Ms. Nagel provided an overview of the treaties that govern U.S. policy on international importation laws. She testified that Customs is the responsible agency for border control and that the Controlled Substance Act is clear that pharmaceuticals can be imported for personal use, but that they must meet certain criteria to enter with substances, which she described in detail.

Ms. Durant of the U.S. Customs Service testified that the agency enforces the guidelines of over 40 agencies and that they need stronger direction from FDA on policies relating to drug importation. In detailing Operation Safeguard, she testified that as much as 90 percent of prescription drug packages coming through the U.S. mail do not meet current regulations due to expired materials, no instructions, counterfeit products, no prescription, and other reasons.

In his testimony before the Subcommittee Mr. Hubbard of the FDA testified that he had recommended to the Department of Health and Human Services earlier that week that the Customs Service should "deny entry of all of these drugs and to return them to their sender." Mr. Hubbard went on to say that FDA would need to create some sort of compassionate use policy to allow drugs in for patients in need of potentially life-saving drugs that do not have FDA approval.

Dr. Leshner then testified before the Subcommittee and presented what science has taught us about psychoactive prescription drugs and their potential for abuse. He described the recent NIDA launching of a major initiative on prescription drug abuse and misuse, as well as discussed efforts to encourage more research into this area and to educate the public about the consequences of abusing prescription drugs. Dr. Leshner stressed that prescription drugs, when taken as prescribed, are important and life-saving tools.

There were no questions asked of Dr. Leshner, the NIH witness.

Prepared by Keith Van Wagner, NIDA