More than a year after first proposing Project Bioshield, President Bush was given the chance last week to put his signature on the legislation, which aims to encourage development of drugs to be used in bioterrorist attacks.
Last week, the House voted 414-2 to pass the $5.6 billion, 10-year antiterrorism legislation that the Senate passed in May. In a news release, Bush said he was looking forward to signing the bill.
But Sen. Judd Gregg (R-N.H.), chairman of the Health, Education, Labor and Pensions Committee and the main sponsor of the bill passed last week, said one Bioshield bill may not be enough. He intends to hold hearings in the fall to consider a follow-up bill that would address drug company concerns not tackled in last week's legislation, he said.
"There are several issues, including liability and antitrust provisions, that I want to review further, and it is indeed likely additional legislation will be warranted," he said in a news release. The current bill offers no liability protection to drug companies if a patient is injured as a result of treatment, for example, a patient dying after receiving a vaccine against the Ebola virus.
The Bioshield legislation awaiting the president's signature aims to encourage development of drugs, treatments and vaccines to guard against potential terrorist agents such as smallpox, anthrax and Ebola by ensuring that drug manufacturers will have a purchaser of such products: the federal government.
Drug companies had expressed concern in the past that a market would not exist for such treatments. The legislation also would allow the government to use such treatments in emergencies without first having to go through the normal approval process. The bill does not include direct funding to hospitals, and the American Hospital Association said it has not taken a stand on the bill.
The American Public Health Association supports the legislation but also expressed concern about proposed cuts in funding to the public health infrastructure for bioterrorism preparedness.
Although the Bioshield bill would provide funding to drug companies and HHS to purchase potential treatments, Bush's overall budget proposal for fiscal 2005 would cut funding to public health bioterrorism programs by $105 million from about $1 billion the sector had been receiving annually since 2002. The administration also is shifting $55 million in federal funding for state bioterrorism preparedness programs. That money is being used instead to develop systems in 21 of the largest U.S. cities for distributing medications and medical supplies rapidly during a public health emergency (May 31, p. 14).
"We would like to see (the $105 million) restored as well as the $55 million" brought back to the states, said Georges Benjamin, executive director of the APHA. He said any legislation providing liability protection must shield providers as well as drug companies.
Bush had first proposed Project Bioshield in his 2003 State of the Union address. The House passed its version a year ago by a 421-2 vote. The bill the House passed last week was the Senate version of the bill and gives Congress greater control over allocation of the funds. The Senate bill passed 99-0.
"This legislation will strengthen our ability to protect Americans against biological, chemical, nuclear and radiological threats," Bush said in a news release. "This will break new ground in the search for treatments and cures, while strengthening our overall biotechnology infrastructure."