Renewal of 2006 preparedness law advances in US House

Jul 28, 2011 (CIDRAP News) – The US House Energy and Commerce Committee today approved legislation to renew and fine-tune a 2006 law that has been credited with significantly improving the nation's preparedness for public health emergencies.

Approval of a bill to reauthorize the Pandemic and All-Hazards Preparedness Act of 2006 drew praise from Trust for America's Health (TFAH), a nonprofit advocacy group, which said the legislation would give states more flexibility in responding to disasters, though it freezes funding at current levels.

Meanwhile, the Department of Health and Human Services (HHS) this week released its 2010 annual report on Project Bioshield, which details the quantities of various medical countermeasures HHS has acquired to blunt the effects of biological weapons. The report says, for example, that the government had bought close to 29 million doses of anthrax vaccine by the end of 2010.

Voice-vote approval
The House committee approved the Pandemic and All-Hazards Reauthorization Act (HR 2405) on a voice vote, according to Becky Salay, director of government relations for TFAH. "We're very pleased to see them work together on a bipartisan basis," she said.

Salay provided a copy of a letter in which Jeffrey Levi, PhD, TFAH's executive director, commended the House committee for moving the legislation.

The bill "will enhance surge capacity and improve the ability of the health care system to quickly expand beyond normal services during a major emergency," Levi wrote. "It gives states flexibility in responding to disasters by allowing the use of personnel that are part of other federal programs in response to public health emergencies. It also enhances the National Health Security Strategy by including ambulatory care facilities and critical care systems in the program, both of which play an important role in the medical response system."

Levi also praised the bill for including language about the needs of children in relation to countermeasures and language "that helps address the preparedness and surge capacity of hospitals for pediatric and other at-risk populations."

In addition, he lauded the legislation for calling for a review of biosurveillance systems, in the interest of achieving "interoperability and transparency" among different systems. The nation lacks an integrated national approach to biosurveillance, and states differ in how fast they collect and report data, he said.

Spending freeze
However, Levi expressed concern that the bill freezes public health preparedness funding at the fiscal-year 2011 levels, which "will not provide sufficient resources to modernize public health systems and ensure we are prepared in the event of an emergency." He said cuts in state, local, and federal funding in recent years have contributed to the loss of an estimated 43,000 state and local public health jobs.

The legislation, the text of which is on the House committee's Web site, calls for $632.9 million per year from 2012 through 2016 for "improving state and local health security." It also authorizes $378 million per year to boost surge capacity at hospitals.

The measure further authorizes $2.8 billion to cover the period of 2014 through 2018 for the special reserve fund of HHS's Biomedical Advanced Research and Development Agency (BARDA). The fund is used to develop and buy medical countermeasures. The bill specifies that the money must not be used for anything other than to develop and acquire countermeasures.

Approval of HR 2405 by the House Energy and Commerce Committee followed its endorsement by the panel's health subcommittee on Jul 26.

The status of a Senate version of the House legislation was not clear today. Salay said her understanding is that the staff of the Senate Health, Education, Labor and Pension Committee is writing a bill.

Project Bioshield report
Project Bioshield is the program through which BARDA develops and buys countermeasures for biological, chemical, radiological and nuclear weapons. Congress established the program in 2004 and authorized $5.6 billion over the decade from 2004 through 2013. HHS is required to give Congress an annual report on the program.

The report for calendar year 2010, released this week, lists the amounts of countermeasures that have been acquired for anthrax, botulinum toxin, smallpox, and radiation exposures. The products are stored in the Strategic National Stockpile.

For anthrax, HHS has acquired a total of 28.75 million doses of the vaccine Anthrax Vaccine Adsorbed, or BioThrax, the report says. That includes 10 million doses delivered under a 2005 contract and 18.75 million doses purchased under a 2007 contract.

In addition, HHS has bought supplies of two different antitoxins that could be used to treat anthrax patients. By the end of 2010, a total of 36,102 doses of a monoclonal antibody called Raxibacumab had been purchased, including 20,000 doses under a 2005 contract and 16,102 doses under a 2009 contract option, which calls for a total of 45,000 doses.

The second anthrax antitoxin is anthrax immune globulin, the report says. HHS contracted for 10,000 doses and had received 7,327 doses by the end of 2010. The report says some doses were sent to the United Kingdom in 2009 for treating anthrax cases among heroin users, but it does not specify how many were provided.

HHS has acquired 96,888 doses of botulinum antitoxin under a 2006 contract that calls for 200,000 doses, according to the report.

For smallpox, HHS has contracted for 20 million doses of the Imvamune vaccine, which is intended for immunocompromised people. By the end of 2010, 2.02 million doses had been delivered, the report says. The government previously bought enough doses of conventional smallpox vaccine to treat the entire US population.

The report also notes that HHS is pursuing antivirals to treat smallpox. Contracts were awarded to two companies for different antivirals earlier this year.

The report also lists a number of emergency use authorizations that were in effect in 2010 for drugs, diagnostics, and other supplies. Most were related to the 2009 influenza pandemic, and most have since been canceled.

See also:

Jul 26 CIDRAP News story "HHS says countermeasures program making progress"

May 18 CIDRAP News story on Senate committee hearing

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