Washington Editor

WASHINGTON - Congressman Gil Gutknecht's idea of helping senior citizens gain access to inexpensive prescription drugs worries the pharmaceutical industry as well as the Bush administration.

But Gutknecht, a Minnesota Republican, gained support from most of his peers in the House when he and co-sponsor Jo Ann Emerson (R-Mo.) persuaded a majority (243-186) to vote in favor of the Pharmaceutical Market Access Act of 2003 (HR 2427).

The legislation would allow almost anyone to reimport almost any FDA-approved drug from a list of 25 countries, including Australia, Canada, Iceland, Israel, Japan, Liechtenstein, New Zealand, Norway, Switzerland, South Africa and those in the European Union.

President Bush, along with Tommy Thompson, secretary of health and human services, and Mark McClellan, FDA commissioner, have raised concerns about the practice of reimporting prescription drugs, arguing that it could compromise patient safety.

Sharon Cohen, vice president for government relations for the Washington-based Biotechnology Industry Organization, told BioWorld Today the legislation provides a legal exemption with respect to biologics. However, she said, if the secretary loses his power under current law to regulate drugs coming into the country, that could make it difficult to police biologics.

Even though it would be illegal to reimport biologics, biotechnology companies as well as pharmaceutical firms would be have to comply with the counterfeit packaging requirement. Cohen said if a product was not properly packaged with a hologram, it would be disbranded or pulled from the U.S. market. "That is a huge issue for the industry," she said. "There's no way conceivably that every company could get this packaging on all their products. You can't do it."

Reimportation legislation has made it through past Congresses and administrations but has never been implemented because it has required the sitting health and human services secretary to demonstrate that it would pose no additional risk to the public health and safety. Neither Thompson nor Donna Shalala, President Clinton's HHS secretary, would sign off on the practice.

The Gutknecht-Emerson bill eliminates that requirement, which may explain why it didn't garner as much support as similar legislation received in 2001, Ed Haislmaier, a board member with the National Center for Public Policy Research, a nonprofit Washington organization, told BioWorld Today.

Gutknecht's 2001 reimportation measure passed 324-101, leading Haislmaier to believe that many supporters voted for it simply to make a point, knowing full well the HHS secretary and FDA commissioner wouldn't let it happen. (See BioWorld Today, July 12, 2001.)

But in a statement released from his Minnesota office, Gutknecht said, "There have been zero reported deaths from Americans taking imported pharmaceuticals. Today, Americans are more likely to be harmed by counterfeit or tainted drugs from within the United States. Worse yet, thousands of Americans become ill or die from food-borne illnesses each year, yet no one suggests banning the importation of food."

Gutknecht-Emerson would allow pharmacists, wholesalers and individuals to reimport prescription drugs for sale or use in the U.S.

"Under the bill, essentially anyone would qualify to import medicines into the U.S.," Alan Holmer, president and CEO of the Washington-based Pharmaceutical Research and Manufacturers of America, said in a prepared statement. "Thus, a convicted felon could run a reimportation business out of his jail cell, reimporting to himself by mail and reselling the products for a significant profit."

PhRMA also is bothered that Gutknecht's bill eliminates the current rules that enable U.S. officials to track the original source of medicines. "This means that medicines purportedly from Europe or Canada might actually have originated in Brazil or Pakistan," Holmer said.

The legislation contains language that would require wholesalers to test each pharmaceutical shipment, unless the packaging uses counterfeit-resistant technology.

While Gutknecht said his intent is to help senior citizens, policy watchers in Washington see something else going on here.

"What they really want to import is the other country's prices, and you don't have to bring the physical product in to do that - that's just a backdoor way of doing it," Haislmaier said. "But if that backdoor way increases the risk level of the safety of the drug supply because of counterfeiting, terrorism and mishandling, then that's kind of stupid, you ought to just be honest and say - here's a drug price control bill. We can have a debate about drug price controls and what that does to the pharma and bio industries vs. what it does for consumers and all the rest without ever getting into reimportation."

Indeed, Sam Kazman, general counsel at the Washington-based Competitive Enterprise Institute, told BioWorld Today his organization supports free trade even when a foreign government is subsidizing its products. "American consumers ought to be able to buy cheap products even if it undercuts American products. But on this issue, we essentially think that we're not dealing with subsidized products; what we are dealing with almost amounts to stolen products," he said. "What's really going on here is that when we import those products, we're not only importing the product, but the price controls themselves.

"In our view, that will give us cheaper drugs in the next month, but it is going to give us far fewer medicines in the future and we think in terms of health, that's a disaster," Kazman said.

Several days prior to the House vote, 53 senators, including Arlen Specter (R-Pa.), Ted Kennedy (D-Mass.) and Orrin Hatch (R-Utah), sent House leaders a letter saying they would not support Medicare legislation that included a reimportation element.

The House Medicare bill passed in June would allow the reimportation of FDA-approved drugs only from Canada.

Sen. Debbie Stabenow (D-Mich.), along with Sens. Chuck Schumer (D-N.Y.) and Byron Dorgan (D-N.D.), introduced legislation in March similar to the House legislation permitting reimportation from Canada. On Friday, Stabenow said, "I believe the House vote, combined with earlier Senate passage of legislation that would allow for the safe reimportation of prescription drugs from Canada, sends a clear message to signal House-Senate conferees that this provision should be a part of the final prescription drug benefit legislation that is now in conference."

Medicare legislation passed by both the House and Senate remains in a conference committee where members consolidate it into one bill.