Companies Push for Renewal of Anti-Bioterrorism Law

January 3, 2013
by Rebecca Adams
Congressional Quarterly

Drug and biotech manufacturers, public health advocates and venture capital investors who are concerned that Congress did not reauthorize a significant anti-bioterrorism bill in the 112th Congress are already lobbying lawmakers to pass it quickly in the new session that began Thursday.

“We’re starting all over again,” said Jeff Levi, president for the advocacy group Trust for America's Health.

In the 112th Congress, both chambers passed versions of legislation that would update the 2006 Pandemic and All-Hazards Preparedness Act, which is known as PAHPA (pronounced “papa,” PL 109-417). The law includes incentives to encourage companies to develop drugs, vaccines and other products that can protect the public from such major health emergencies as a biological attack or pandemic flu. The idea is to give certainty to manufacturers that the federal government will buy and support the development of products that hopefully will never be used.

The law supports the Health and Human Services office known as the Biomedical Advanced Research and Development Authority as well as the Center for Disease Control and Prevention’s Strategic National Stockpile, which is the federal warehouse of antibiotic drugs, vaccines, chemical antidotes, antitoxins and other medical supplies that can be sent to protect the public from a public health crisis.

Sen. Richard M. Burr, R-N.C., one of the original authors of the law, had held up its reauthorization in the hope of attaching other unrelated provisions affecting drugs to it. He wanted to include “track and trace” provisions designed to improve prescription safety by clarifying how the Food and Drug Administration can monitor products throughout the supply chain to prevent counterfeit products from being provided to patients. Burr’s office said Thursday that the senator still hopes that lawmakers can reach an agreement and pass the bioterrorism reauthorization.

As the session drew toward a close, the Senate scrambled to pass a narrow provision on Dec. 30 that would extend a PAPHA anti-trust exemption allowing drug developers to work together on products that could protect the public. But that legislation also died when the House did not act on it.

Major companies, such as Novartis Corp.; Bavarian Nordic, Inc.; Glaxo Smith Kline; and Sanofi Pasteur Inc., are watching the issue closely because they develop products that are part of the nation’s arsenal against public health threats. Lower-profile companies such as PharmAthene, Emergent BioSolutions and Human Genonme Sciences, Inc., also are pushing lawmakers to renew the law. Some of those companies are part of a coalition known as the Alliance for Biosecurity.

“This issue remains a top priority for BIO,” said Jim Greenwood, president of the Biotechnology Industry Organization. “We strongly support reauthorization of PAPHA. We look forward to continuing to work with Congress to get this accomplished as soon as possible in 2013.”

The reauthorization bills contained some provisions that updated or tweaked public health and product procurement policies, but the biggest reason why advocates want it to be reauthorized is that it will help ensure that funding for various bioterrorism programs will continue at robust levels. Appropriators can continue providing funds for the programs even though their authority has expired, but a reauthorization helps persuade lawmakers that they should be fully funded. The expiration of the law makes companies that develop the products and their investors nervous.

“A lot of what this law is about is creating confidence within the private sector that the government is committed to these programs over the long term,” said Levi. “It sends a very bad message to the very people we need to continue their commitment to this kind of work.”