Former FDA Commissioner David Kessler Endorses Prescription Drug Reimportation Bill

Former FDA Commissioner David Kessler on Tuesday at a Senate Health, Education, Labor and Pensions Committee hearing recommended that Congress pass a bill (S 334) that would allow U.S. residents to reimport lower-cost prescription drugs from other nations, the Los Angeles Times reports.

According to Kessler, currently dean of the University of California-San Francisco School of Medicine, the legislation would establish a "validated system" of reimportation that would protect residents from counterfeit and unsafe medications.

The bill, sponsored by Sens. Byron Dorgan (D-N.D.) and Olympia Snowe (R-Maine), would allow residents to reimport prescription drugs for personal use from FDA-approved Canadian pharmacies. After 90 days, the legislation would allow licensed pharmacists and prescription drug wholesalers to reimport medications from Canada. After one year, pharmacists and wholesalers could reimport medications from Australia, Japan, New Zealand, Switzerland or E.U. nations that were members as of Jan. 1, 2003.

Pharmacists and wholesalers that reimport prescription drugs would have to register with FDA and pay fees of as much as 1% of the price of the medications to fund the cost of additional federal inspectors and customs agents and track and document the chain of custody of medications from manufacturer to consumer. In addition, the bill would phase in FDA review of notices of the foreign versions of FDA-approved prescription drugs to determine whether they are the same or different than current medications approved for use (Alonso Zaldivar, Los Angeles Times, 4/20).

Kessler testified that many U.S. residents currently reimport prescription drugs without the safety provisions included in the legislation. He said, "We already have a system of importation of drugs that jeopardizes public health. Congress has the responsibility to fix this serious problem" (Rowland, Boston Globe, 4/20).

Kessler said, "The choice before you is not the choice of imports or no imports," adding, "The American public will be safer with a regulated system than with the current system of uncontrollable risk" (Los Angeles Times, 4/20).

The endorsement from Kessler "contrasted with stark warnings from other witnesses" who oppose the legislation, Knight Ridder/Kansas City Star reports. Thomas Arthur, dean of the Emory University School of Law, said that the legalization of reimportation would import foreign price controls to the United States.

In addition, Graham Satchwell, who directs a British company that helps pharmaceutical companies implement anti-counterfeit measures, said that the legalization of reimportation could increase the number of counterfeit medications in the U.S. prescription drug supply (Pugh, Knight Ridder/Kansas City Star, 4/20).

Sen. David Vitter (R-La.), who has introduced a different reimportation bill (S 109) that "puts more emphasis on anti-counterfeit and anti-tampering technology," said that he would "enthusiastically vote" for the Dorgan-Snowe bill, CQ Today reports (Schuler, CQ Today, 4/19).

Vitter said, "Safety is a huge reason we must pass legislation like this. Unless we act on this legislation at once, we're allowing a safety problem to grow and grow" (Shields, Baton Rouge Advocate, 4/20).

Committee Chair Michael Enzi (R-Wyo.) said that he plans to introduce a separate reimportation bill that would include provisions from the Dorgan-Snowe bill and other legislation. He said that he will "work to deliver a bill that will allow for safe importation" (Los Angeles Times, 4/20).

According to CQ Today, Enzi "called for a review of the issue and stipulated that any measure would have to protect patents and avoid restricting trade." Enzi also "hinted that he would consider a pilot program" and asked Dorgan to help him develop a "local approach," CQ Today reports. (CQ Today, 4/20).

Enzi spokesperson Craig Orfield said, "He's convinced that drug importation is going to occur in some fashion, and his view is that we have to come up with a middle ground that provides safety for consumers" (Boston Globe, 4/20). An Enzi spokesperson said that 60 senators likely would support reimportation legislation (Los Angeles Times, 4/20).

Sen. Judd Gregg (R-N.H.) "grilled" Snowe at the hearing about provisions in the Dorgan-Snowe bill that would revise the FDA approval and inspection system, CQ Today reports. He said, "To step into this area requires that we do it correctly, and I have some serious reservations" (CQ Today, 4/19).

He said, "Your bill has taken a hundred years of law ... and essentially replaced it with 40 pages of regulations, which you won't even explain" (Heil, CongressDaily. 4/19). Gregg added, "We have a system that works, but when you open it up to the world, whether it's Greece or Canada, you want something that will cure you not kill you."

Dorgan said, "This is not a safety issue. It's a question of who we're going to stand with -- the consumers or the pharmaceutical industry" (Baton Rouge Advocate, 4/20). He added, "My goal is to have an action by Congress that broadly allows the American people to import prescription drugs."

Snowe said, "We all know that a drug that's not affordable is neither safe nor effective" (CQ Today, 4/20).

NPR's "Morning Edition" on Wednesday reported on the reimportation hearing. The segment includes comments from Enzi, Vitter, Rep. Johnny Isakson (R-Ga.) and Kessler (Rovner, "Morning Edition," NPR, 4/20). The complete segment is available online in RealPlayer.