Washington Editor

WASHINGTON - In a move criticized by the Democrats as a last-minute tactic to win the senior voting block, President Bush recommended a generic drug plan that would make it more difficult for pharmaceutical companies to retain market exclusivity by extending their patents.

The Bush plan, introduced in the form of an FDA rule that requires a 60-day comment period commencing Oct. 24, follows recommendations made recently by the Federal Trade Commission (FTC) at a House subcommittee meeting. Washington insiders said it likely would be a year before the rule is effective. (See BioWorld Today, Oct. 10, 2002.)

The primary issue is closing a loophole in the Hatch-Waxman Act of 1984 that has allowed brand-name companies to keep generics off the market by stacking automatic 30-month patent extensions when a generic company files for FDA approval. (Biologics are not included under Hatch-Waxman.)

Bush's rule would limit a brand-name company to one 30-month patent extension per generic application, and it proposes to clarify the types of patents that could be submitted to the FDA for protections. The patents are listed in what's known as the "Orange Book."

In his Rose Garden speech Monday morning, Bush explained how some companies have manipulated the system, saying, "When a drug patent is about to expire, one method some companies use is to file a brand new patent based on a minor feature, such as the color of the pill bottle or a specific combination of ingredients unrelated to the drug's effectiveness. In this way, the brand-name company buys time through repeated delays, called automatic stays, that freeze the status quo as the legal complexities are sorted out."

Bush seeks to stop this by limiting patents to active ingredients, drug formulations and uses of a drug. Patents on drug packaging, drug metabolites and intermediate forms of a drug would be prohibited.

Since the plan was only released Monday morning, representatives from Washington trade organizations were not quick to comment in detail. Dan Eramian, vice president for communications for the Biotechnology Industry Organization, told BioWorld Today, "Based on the president's comments this morning, [the plan] appears to reinforce the original spirit of Hatch-Waxman of 1984."

And Jeff Trewhitt, a spokesman for the Pharmaceutical Research and Manufacturers of America, told BioWorld Today that the plan was too complex to comment on without further study.

Kathleen Jaeger, president and CEO of the Generic Pharmaceutical Association, released a prepared statement saying, "The components of this proposed regulation would begin the process of restoring balance to the Hatch-Waxman Act, but we believe that legislation is still necessary to codify and strengthen today's encouraging announcement."

In a press briefing following the Rose Garden address, a senior White House official was asked if this announcement was timed to help Republican candidates who are being attacked on domestic issues.

"The truth of the matter is, is we've been working on this for well over a year and we brought it to the president, and the president liked it. This has been in the works for a good period of time. The election was way out in the future when we started on this."

While the FTC completed its report, "Generic Drug Entry Prior to Patent Expiration," in July, representatives from the commission were on Capitol Hill recently to explain the findings to a House committee that raised a number of concerns about pharmaceutical and generic companies "gaming" the industry to keep competition off the market.

In one such way, Timothy Muris, chairman of the FTC, alleged that Abbott Park, Ill.-based Abbott Laboratories paid Geneva Pharmaceuticals Inc. $4.5 million per month to delay entry of its generic Hytrim product onto the market.

Meanwhile, the White House was questioned for failing to include a provision to deal with companies that strike secret, manipulative deals and for failing to include new off-label uses of drugs.

In response, the White House official said, "We can only go so far under the law administratively. These are things that may have to be addressed in further legislation."

Referencing new off-label uses, the official said oftentimes a different indication is a medical innovation, which patents are intended to protect.

In July, the Senate passed legislation (S.812) authored by John McCain (R-Ariz.) and Chuck Schumer (D-N.Y.) that limits pharmaceutical companies to one 30-month extension on patents that were filed with the new drug application.

The House has not passed companion legislation.