Washington Editor

WASHINGTON - As President Bush prepares to sign Project BioShield, industry leaders and other stakeholders are looking to transform the legislation's weaknesses into strengths in the upcoming BioShield II.

However, if there's one element that everyone agrees on, it is that $5.6 billion over a decade is not nearly enough money to tackle the drug development and procurement process.

Bush introduced Project BioShield to the nation in his State of the Union address in January 2003. The idea was to speed development and availability of countermeasures to biological or chemical threats by streamlining government research, creating incentives for companies to take on the research and providing the FDA with the authority to make investigational products widely available in a public emergency.

After a heavy-handed rewrite in the House and Senate, a single bill, often referred to as "workable" by the industry, has emerged as the first piece of legislation meant to get the countermeasures program off the ground.

To help interested parties gain a better understanding of BioShield's provisions, Equity International Inc., of Washington, along with Aventis Pasteur Ltd., the vaccines business of Aventis SA, of Strasbourg, France; McKenna Long & Aldridge LLP, of Philadelphia; and The Federal Market Group, of Warrenton, Va., held a briefing here.

Much of the $5.6 billion allocated for BioShield will be used to buy countermeasures, not to develop them. In the current budget, $890 million has been allocated for the project, compared to a proposed $2.5 billion in 2005.

Bush is expected to sign BioShield in the next few weeks. Though getting BioShield to Bush's desk had not been simple, insiders believe that BioShield II will have an easier journey because the concept has been accepted.

Indeed, the first BioShield is missing a few key elements, such as indemnity and certain tax incentives. Chuck Ludlam, an attorney for Sen. Joe Lieberman (D-Conn.), who is expected to spearhead BioShield II, said some of those issues will be taken up in BioShield II.

For example, the lack of indemnity protection is an obvious problem because many countermeasures under evaluation will not be required to run through Phase III studies for stockpiling and use in an emergency. BioShield allows approvals based on Phase I/II studies or animal models.

Current law does provide some legal protection in that the government has authority to reimburse companies for monies paid out in the type of lawsuit that could result from an emergency requiring a countermeasure, said Christopher Bouquet, an attorney with McKenna Long & Aldridge in Washington.

Also, there's the safety act, which was approved Nov. 25, 2002, as part of the Homeland Security Act of 2002. The legislation provides comprehensive liability protection for providers of homeland security technology to all segments of the market place, whether commercial or government, thereby dramatically reducing the tort liability of manufacturers and suppliers should their products or services allegedly fail to interdict a terrorist act, according to documentation provided by McKenna Long & Aldridge.

Only those manufacturers and suppliers whose products and services are reviewed and approved by the Department of Homeland Security will be protected under the safety act.

Meanwhile, to encourage firms to take interest in developing countermeasures, Ludlam said he hopes to include tax incentives in BioShield II.

But whether an industry-friendly BioShield II would make it through the House and Senate is another issue. In the House, BioShield passed in a 421-2 vote, compared to a 99-0 vote in the House. (See BioWorld Today July 23, 2003, and May 20, 2004.)

Josh Dozor, a panelist and legislative assistant in Rep. Curt Weldon's office (R-Pa.), said while Weldon is committed to passing BioShield II complete with tax incentives and legal protections, others in Congress might not be so willing.

Many lawmakers are hesitant about providing such rich incentives to an industry that is so profitable, he said. Furthermore, while the first BioShield was being debated, there was an attitude that a biological or chemical threat was not imminent, Dozor said.