Washington Editor

WASHINGTON - Federal bird flu funding has hit a snag on Capitol Hill.

Last week, members of the House Energy and Commerce Committee balked at the cost of President Bush's $7.1 billion pandemic preparedness plan. Notably, the committee's chairman, Rep. Joe Barton (R-Texas), said "wasting taxpayer money" would not prevent "people from catching the flu." Others questioned the burden to be placed on states under the administration's proposal, which was issued earlier this month, with states being asked to purchase their own stocks of antivirals. (See BioWorld Today, Nov. 2, 2005.)

Barton's comments were contrary to the hearing's featured speaker, Health and Human Services Secretary Mike Leavitt, who formally presented a budget request to the committee, which has oversight of public health programs. He said the need for an additional $6.7 billion in HHS appropriations for the coming fiscal year would put the plan's key components into action: to enable pandemic flu vaccine for every American within six months of an outbreak, to provide enough antiviral drugs and other medical supplies to treat more than a quarter of the nation's population and to ensure a domestic and international capacity to respond to a pandemic.

About two-thirds of the requested funding would go toward investments in creating pandemic flu vaccine production capacity by way of cell-based production technology and stockpiles.

As House members contemplate the administration's pandemic preparedness proposal, amid broader federal budget reconciliation matters that are occupying many minds here these days, the Senate already has passed a $7.9 billion emergency appropriation for bird flu.

Not surprisingly, though, critics of the plan continue to voice their concerns. Several public health organizations, including the Federation of American Scientists and Trust for America's Health, have charged that the administration's budget request does not provide sufficient resources. Specifically, they complained that issues around vaccine liability and compensation are not yet adequately addressed, and also criticized placing the purchasing burdens on states.

Lawmakers Urge Passage Of SBIR Bills

Sen. Christopher Bond (R-Mo.) and Rep. Sam Graves (R-Mo.), along with several patient advocacy groups and other interested parties, released a letter to urge Congress to pass legislation the two lawmakers introduced earlier this year to broaden biotech companies' eligibility for Small Business Innovation Research (SBIR) grants. At present, companies that are more than half owned by venture capital firms are ineligible for the R&D awards, according to rules administered by the Small Business Administration.

Bond said the country "cannot afford to stifle innovation," and Graves called the bill "essential for many small businesses that are trying to do big things." The Biotechnology Industry Organization has lobbied to reverse the exclusion, arguing its position particularly loudly this year. Jim Greenwood, the trade association's president and CEO, called the letter "the voice of millions" and said that "bureaucracy has blocked" research into cures. (See BioWorld Today, June 20, 2005, and July 28, 2005.)

Titled the "Save America's Biotechnology Innovation Research Act," the bills are S.1263 and H.R. 2943. The letter, addressed to leaders in both chambers of Congress, was signed "on behalf of America's patients, medical technology and biotechnology" by more than 60 organizations.

FDA Publicizes Latest Drug Warnings

Revised labels have been attached to two drugs belonging to Biogen Idec Inc., Amevive (alefacept) and Zevalin (ibritumomab tiuxetan), as well as Ligand Pharmaceuticals Inc.'s Avinza (morphine sulfate extended-release capsules).

The amended label for Amevive, which is indicated for adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, states it shouldn't be administered to HIV patients. The product reduces CD4+ T lymphocyte counts, which might accelerate disease progression or increase complications of disease in those patients, according to the FDA. For Zevalin, a cancer therapy for non-Hodgkin's lymphoma, the agency and the Cambridge, Mass.-based company notified health care professionals of severe cutaneous or mucocutaneous reactions, some with fatal outcome, that have been reported in association with the therapeutic regimen.

In the notice on the pain product Avinza, the San Diego company and the FDA revised its label to highlight and strengthen a warning that patients should not consume alcohol while taking the drug. Correspondingly, they cannot use prescription or non-prescription medications containing alcohol while on Avinza.