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Oct 29, 2001
 |  BioCentury  |  Politics, Policy & Law

Getting aligned on biodefense

Sen. Edward Kennedy (D-Mass.) last week circulated draft legislation that would remove regulatory and financial barriers to industry involvement in biodefense activities and provide financial incentives. Rep. Bob Menendez (D-N.J.) released an outline for legislation with similar objectives. Senior Republicans in the House and Senate expressed support for the general principles in both bills but balked at the price tags - $10 and $7 billion, respectively. The parties are discussing compromises that would trim the costs.

Kennedy's bill, which was drafted with input from the Biotechnology Industry Organization (BIO), would authorize the government to enter into long-term contracts for R&D and manufacturing of vaccines, therapies, diagnostics and other bioterrorism countermeasures.

The bill has provisions that could facilitate the participation of smaller companies. For example, it allocates $2 million for fiscal 2002, which began this month, for the FDA to provide "intensive assistance, including on-site assistance when necessary," to help manufacturers of priority countermeasures comply with GMP regulations. An additional $20 million in fiscal 2002 would be dedicated to supporting the development and expansion of production capacity.

Addressing an issue of concern to the biotech industry, the bill earmarks $10 million in 2002 to help companies beef up the security of research, distribution and storage facilities involved with...

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