Washington Editor

WASHINGTON - Legislation authorizing Project BioShield, a program designed to encourage drug companies to develop biomedical countermeasures against potential biological weapons, is nearing a vote in the Senate, sources told BioWorld Today.

Passage of the legislation would make $6 billion available for drug discovery, development and possibly manufacturing as they relate to bioterrorism over the next decade. BioShield legislation made it though the House in July in lopsided vote of 421-2. The Senate Health, Education, Labor and Pensions Committee in March unanimously approved a version of BioShield crafted by the Bush administration. (See BioWorld Today, March 28, 2003; April 7, 2003; and July 23, 2003.)

Project BioShield is the administration's plan to speed development of bioterrorism countermeasures by streamlining government research, creating incentives for companies and giving the government the ability to make products widely available in a public emergency.

The Senate version (S.18) contains a provision that would require mandatory or indefinite funding, an element that prompted lively debate in the House. Supporters of the Bush version argue that mandatory funding is necessary to keep BioShield afloat.

Rep. Henry Waxman (D-Calif.) and others oppose the funding proposal, calling it a "blank check" approach to buying biologics and drugs. As a result, the House bill makes BioShield subject to the annual appropriations process.

The industry is desirous of mandatory funding because it guarantees a market for drugs to treat smallpox, anthrax or botulism, which are possible biological weapons.

BioShield apparently has been held up in the Senate because of the funding issue, according to Washington insiders. Nevertheless, Congress is aiming to end the year's session in mid-November, leading insiders to believe a vote in the Senate is within weeks.

Outside of funding, another area of contention involves legal protection for companies producing countermeasures that are needed quickly and don't go through the normal FDA procedures for drug review.

The House version does not include an indemnity element. If such protection does not make it into the Senate or final version, there's a belief that indemnity can be settled by way of an amendment to the Homeland Security Act. (See BioWorld Today, May 19, 2003.)

U.S. Citizens Like Reimportation

About 70 percent of people responding to a Washington Post-ABC News poll said it should be legal for U.S. citizens to buy prescription drugs outside the U.S.

Plenty of lawmakers agree, and they are taking steps to make the practice of reimporting FDA-approved drugs from other countries legal.

Although reimportation legislation passed during the tail end of the Clinton administration, it was never implemented because Donna Shalala, former secretary of Health and Human Services, refused to sign off on it, saying she couldn't demonstrate that it would pose no additional risk to public health and safety. Tommy Thompson, Bush's HHS secretary, refused to OK it for the same reason.

Medicare reform legislation currently being negotiated in a House-Senate conference committee contains a reimportation element that would allow U.S. citizens to reimport drugs from countries including Australia, Canada, Iceland, Israel, Japan, Liechtenstein, New Zealand, Norway, Switzerland, South Africa and the European Union.

Authored by Reps. Gil Gutknecht (R-Minn.) and Jo Ann Emerson (R-Mo.), the pending legislation does not require the sitting HHS secretary to certify that the practice is safe. (See BioWorld Today, July 28, 2003.)

Conference committee members have been negotiating Medicare reform legislation since mid-summer, and it is widely believed that discussions will continue beyond a possible mid-November recess.

While reimportation does not include biologics, the Washington-based Biotechnology Industry Organization opposes the measure partially because it would be difficult to police what's coming over the borders.

Several days prior to the House vote of 243-186 in favor of reimportation, 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.

ASCO Gaining Support On Drug Reimbursement

Sens. Sam Brownback (R-Kan.) and Dianne Feinstein (D-Calif.) wrote a letter to the Senate leadership encouraging them to consider the American Society of Clinical Oncology's (ASCO) proposal to fix the reimbursement system for cancer care in the pending Medicare bill, ASCO said.

ASCO's proposal would set 112 percent of average sales price as the permanent payment for oncology drugs, and would transition drug payments from the current payment amount of 95 percent of the average wholesale price to the new rate over a four-year period.

The Medicare legislation as it currently stands includes provisions that would remove $16 billion from the cancer care system over 10 years.

Pediatric Trials Legislation Hasn't Reached House

Legislation requiring drug makers to run clinical trials on adult products that could be used off-label in the pediatric population made it through the Senate in July, but has yet to make it through to the House floor for a vote.

Supporters of pediatric trials at the American Academy of Pediatrics in Washington believe the matter will come before the House prior to the end of the session.

The Senate in July passed the "Pediatric Research Equity Act," handing the FDA authority to mandate pediatric studies in new drugs, biologics and some products already on the market. The legislation would essentially restore the 1998 "Pediatric Rule" that was struck down in October 2002 when a U.S. District Court judge said the FDA didn't have the power to force companies to conduct such studies. (See BioWorld Today, July 25, 2003.)