Washington Editor

WASHINGTON - The Senate's inability to agree on a prescription drug plan for Medicare recipients doesn't necessarily mean seniors will lose access to cheaper drugs.

It just means that the elderly may have to wait a little longer to get their hands on discounted prescription drugs.

The House passed its prescription drug plan in June, but for a month the Senate battled over four different proposals and ended up gridlocked a day before the month-long summer recess. (See BioWorld Today, June 24, 2002; July 25, 2002; and Aug. 1, 2002.)

So in September the Senate is expected to continue arguing over whether a prescription drug plan should be administered by the government or by private health care companies.

But the divided chamber did pass legislation Wednesday that would strike a devastating blow to the biologics and pharmaceutical industry, that is, if a similar bill makes it through the House and ends up on the president's desk.

Infamous to the industry, the Senate passed a bill (S.812) to reform the Hatch-Waxman Act of 1984 by closing loopholes that have enabled the industry to extend drug patents. Supporters of S.812, also referred to as Edwards-Collins after its sponsors, Sens. John Edwards (D-N.C.) and Susan Collins (R-Maine), claim the drug industry has exploited Hatch-Waxman by delaying generic competition, keeping the cost of medications high.

A Hatch-Waxman loophole allows drug companies to file 30-month stays on each patent covering a drug upon its expiration. Under Edwards-Collins, only one 30-month stay would be permitted, regardless of the number of issued patents covering a drug.

The Washington-based Biotechnology Industry Organization (BIO) opposes Edwards-Collins for a number of reasons, saying it would "topple the delicate balance within the prescription drug patent system, which, since the 1984 Hatch-Waxman Act, has helped speed the approval of generic drugs while maintaining the market incentives for innovators."

In a letter to Sen. Edward Kennedy (D-Mass.) criticizing Edwards-Collins, Carl Feldbaum, BIO's president, said the legislation also would selectively codify certain regulations governing bioequivalence requirements and would legislatively shield the FDA from challenges to its actions in setting approval standards. Bioequivalence is the determinant of safety and efficacy of a generic drug. (See BioWorld Today, July 17, 2002.)

An attachment to Edwards-Collins sure to raise eyebrows in the industry and among the House GOP is a section that allows the reimportation of FDA-approved drugs from Canada.

The reimportation proposal, added by Sen. Byron Dorgan (D-N.D.), will not be effective unless Tommy Thompson, secretary of Health and Human Services, certifies it as safe. A similar measure was passed under the Clinton administration but never went into effect because former HHS Secretary Donna Shalala would not certify that it was safe. (See BioWorld Today, Oct. 2, 2000; Dec. 29, 2000; and July 19, 2002.)

The House Energy and Commerce Subcommittee on Health held a hearing last week to take up safety discussions surrounding reimporting prescription drugs from Canada.

At issue is the growing number of seniors crossing the Canadian border to purchase prescription drugs. Government controls keep the prices lower in Canada than in the U.S.

"While these trips provide seniors with access to cheaper drugs, they also provide seniors with access to drugs which may not be as safe and as effective as drugs approved by the FDA," said Rep. Billy Tauzin (R-La.), chairman of the committee.

However, Rep. Sherrod Brown (D-Ohio) said reimportation is one of the only ways of protecting U.S. consumers, companies and tax dollars from "grossly inflated drug prices."

Brown said reimportation is a symptom of the fact that Americans pay two, three and four times more than consumers in any other country for drugs manufactured by the very same companies, in the very same facilities.

"This administration and this Congress hang on every word when multibillion-dollar drug companies spew their self-serving rhetoric attacking reimportation, Hatch-Waxman reform, and any other attempt to get a fair deal for American consumers," Brown said.

But Tauzin reminded committee members that Shalala - a Democrat - failed to certify reimportation as safe. "Was the Clinton administration in the pocket of drug companies? Was Donna Shalala in the pocket of drug companies? That should tell you something. All Donna Shalala had to do was certify it - but she couldn't - she couldn't say it was safe," Tauzin said.

William Hubbard, a senior FDA official, told committee members that Thompson recently said, "Opening our borders to reimported drugs potentially could increase the flow of counterfeit drugs, cheap foreign copies of FDA-approved drugs, expired and contaminated drugs, and drugs stored under inappropriate and unsafe conditions. In light of the anthrax attacks of last fall, that's a risk we simply cannot take."

Thompson's comments were made in June at BIO's international conference held in Toronto.