Washington Editor

WASHINGTON - A group of Democratic senators want to open the Canadian border and allow pharmacists and drug wholesalers to reimport FDA-approved drugs to sell in the U.S. at discounted prices.

While the legislation excludes biologics, Sharon Cohen, vice president of government relations at Washington-based Biotechnology Industry Organization, said BIO strongly opposes it.

"There have been various bills that have exempted biologics, but that still doesn't stop us from having strong opposition because that presumes there are good actors who will comply with the law," she told BioWorld Today. "But then there are bad actors. When something's coming across the border, how does a customs agent look at it and determine whether it's a biologic? Biologics, in many instances, need to be handled in a certain way. Who knows what happens when something sits on a dock in some other country before it enters this country?"

At a press conference here on Wednesday, Sen. Byron Dorgan (D-N.D.), flanked by Sens. Charles Schumer (D-N.Y.) and Debbie Stabenow (D-Mich.), said, "We must do something to put downward pressure on drug prices."

He introduced the reimportation legislation as part of a larger Democratic Leadership bill on prescription medicines (S. 7), and he also intends to introduce it as stand-alone legislation (S. 54). The legislation would give individuals a waiver to reimport prescription drugs from Canada as long as the medicine is for personal use.

It also includes a "non-discrimination" provision intended to stop drug manufacturers from circumventing the law by manipulating the supply of product sold to Canadian pharmacists and wholesalers. A similar measure was introduced in the House last week. (See BioWorld Today, Feb. 28, 2003.)

The House legislation, introduced by Reps. Bernard Sanders (I-Vt.), Joseph Crowley (D-N.Y.) and Dan Burton (R-Ind.), was initiated after London-based GlaxoSmithKline plc announced its policy to reduce shipments to Canadian companies known to resell discounted drugs in the U.S. (See BioWorld Today, Feb. 18, 2003.)

As mentioned by Cohen, the Dorgan legislation isn't the first attempt at legalizing reimportation from Canada or other countries. In fact, such an amendment passed the Senate last year as part of legislation (S. 812) crafted by John McCain (R-Ariz.) and Schumer, designed to reform Hatch-Waxman, the act that created the generic drug industry. (See BioWorld Today, Sept. 3, 2002, and Oct. 10, 2002.)

President Bush never signed McCain-Schumer, effectively killing it for 2002.

But it's back again. When introducing it Wednesday, Schumer reminded reporters that it passed the Senate last summer with 78 votes.

Specifically, McCain-Schumer (Greater Access to Affordable Pharmaceuticals) gives brand-name companies one 30-month stay (to be given only if one of the brand company's original patents is challenged), thereby eliminating multiple 30-month delays in generic drug approval and discouraging frivolous lawsuits.

It also strips the 180-day market exclusivity from "first-to-file" generics. It has been found that generic companies have abused the incentive by making deals with brand companies and staying off the market in return for payment, Schumer said. Finally, McCain-Schumer prevents challenges to the FDA's authority to approve new generic equivalents by clarifying that the FDA's regulations regarding bioequivalence have the effect of law.

Also on Wednesday, Sen. Stabenow said she'll introduce "Rx Flexibility for States Act," a reprise of her 2002 legislative language also approved in the Senate last year. The bill would permit states to extend Medicaid rebates and discounts for prescription drugs to non-Medicaid-eligible people.

"Many states have developed innovative programs to help make prescription drugs more affordable, but these programs have faced legal challenges by the pharmaceutical industry," she said. "This legislation will help states clear those legal hurdles and pass on Medicaid rebates and discounts to their residents."

In particular, Stabenow mentioned the case between the state of Maine and the Washington-based Pharmaceutical Research and Manufacturers of America (PhRMA).

PhRMA contents that Maine Rx (a prescription drug program for the state's 325,000 uninsured residents) interferes with the federal Medicaid program and violates the Commerce Clause of the Constitution, which prohibits states from regulating transactions outside their borders. (See BioWorld Today, Oct. 30, 2000, and July 1, 2002.)

The U.S. Supreme Court has agreed to hear the case.