Washington Editor

WASHINGTON - Senators from both sides of the aisle have joined together to introduce the Project BioShield II Act of 2005 as follow-on legislation to the original BioShield Act that was signed into law not quite a year ago.

Late last week, Sens. Joe Lieberman (D-Conn.), Orrin Hatch (R-Utah) and Sam Brownback (R-Kan.) unveiled their bill to establish a system that provides the country with medicine to combat the threat of bioterrorism. Like its forebear, it is designed to encourage companies to develop new bioterror antidotes and countermeasures, but the new bill goes further to reduce their financial risks. Despite the first bill's promise of $5.6 billion over 10 years for government contracts, the BioShield II authors argued that there is a need to address economic obstacles that hinder bioterrorism product development.

"They recognize that BioShield I was a first step," said Francesca Cook, the vice president of policy and public affairs at PharmAthene Inc. in Annapolis, Md. "It showed the world that the government was committed."

The newly proposed legislation aims to address risks said to inhibit development. Such further incentives to promote the development of new countermeasures are necessary, the senators said, because there is no market for those remedies unless there is a national disaster.

"Now the government realizes that big pharma has not come to the table," Cook told BioWorld Today, adding that "even for the little guys like us," there needs to be additional incentives and safeguards to entice further research. So the BioShield II bill includes tax breaks, intellectual property protections such as patent incentives that could help spur countermeasures, as well as liability protections to companies who produce vaccines that cannot be fully tested in clinical trials because of the nature of the deadly diseases they are designed to combat.

That last point, Cook noted, could prove most pivotal for companies thinking of beginning bioterror programs. Currently, she said, many fear reprisals such as lawsuits that followed the distribution of Cipro (ciprofloxacin, from Bayer Pharmaceuticals Corp.) after the 2001 anthrax attacks. In partnership with Medarex Inc., of Princeton, N.J., PharmAthene has a monoclonal antibody called Valortim in development that could potentially be used as both a vaccine and treatment for anthrax exposure, but should it eventually receive a contract for a government stockpile, the product would have been approved for investigational new drug application-stage development but not for marketing. That would leave PharmAthene and other such companies susceptible to legal ramifactions.

"Companies have a lot of liability there," Cook said, pointing to lawsuits that Bayer endured. "Other companies don't want to be in that position."

The newly proposed legislation, under which the government would assume responsibility for non-FDA-approved products in humans, does not allocate a specific funding amount for the provisions but promises federal funding only for products that meet the government specifications.

Earlier this year, the Senate's Republican leadership introduced another bill designed to combat bioterrorism and infectious diseases, but BioShield II is designed to be more comprehensive. Another bioterrorism bill also has been introduced in the House.

All such legislation follows Lieberman's lead in late 2001, when he first introduced a bill to provide incentives for research on bioterrorism countermeasures. Lieberman and Hatch subsequently introduced updated versions of the bill that last summer was signed into law as BioShield by President Bush.

Medical Reimbursement Issues Coming

As drug development shifts more and more toward patient-specific needs, sweeping reimbursement processes also are changing as such issues loom on the not-so-distant horizon.

So said Scott Gottlieb, a resident fellow at the American Enterprise Institute, during last week's BIO-Windhover gathering here. A former official at the Centers for Medicare and Medicaid Services, he said the government agency's all-or-nothing approach to making drug reimbursement decisions would not be viable in an era of personalized medicine.

"That drove the need for a new approach about drug coverage decisions," he said.

Relative to drugs that fall under Part B, CMS has begun to employ data from post-approval studies to gauge information on drug use. The agency will cover products broadly, but it wants market-based evidence to support its decisions.

Such a process could prove beneficial to off-label use. CMS will reimburse drugs when used for indications other than their approved use, and Gottlieb said companies could take that into consideration when deciding whether to seek supplemental new drug applications through the FDA.

As for products to be covered by Part D when the prescription benefit kicks in at the beginning of next year, he expects that CMS won't soon make coverage decisions on such drugs. Instead, the agency will "look at private plans and how they behave," he said.

FDA Issues Caution On Natrecor, Betaseron

The FDA recently notified consumers of updated warnings on two marketed products, the heart failure drug Natrecor (nesiritide) and the multiple sclerosis drug Betaseron (interferon beta-1b).

The agency ordered that more information about Natrecor be added to its package insert after pooled results from seven studies suggest that it might increase patients' risk of death within 30 days of treatment. Four of the studies found an increased risk of death compared with other treatments, and three found a decreased risk.

The drug's safety has been questioned in recent editions of the Journal of the American Medical Association and Circulation. Natrecor is marketed by Johnson & Johnson, the New Brunswick, N.J.-based company that two years ago paid $2.4 billion to acquire the drug's developer, Scios Inc.

Separately, the FDA issued warning material on Betaseron, noting that reports of serious hepatic injury from post-marketing safety surveillance of the product include autoimmune hepatitis and severe liver damage leading to hepatic failure and transplant. Testing of liver function is recommended at intervals of one, three and six months following introduction to Betaseron therapy, and then periodically thereafter in the absence of clinical symptoms.

The drug is marketed by Berlex Inc., of Montville, N.J.

New Cancer Division At Agency

The FDA recently established the Office of Oncology Drug Products, and named Richard Pazdur its head in the process.

The division, placed within the Center for Drug Evaluation and Research (CDER), is a consolidation of three previous areas within CDER responsible for the oversight of drugs and therapeutic biologics associated with cancer treatment and prevention. They include the Division of Oncology Drug Products, which Pazdur had overseen, as well as the Division of Oncology Biologic Products and the Division of Medical Imaging and Hematology Drug Products.

The Office of Oncology Drug Products also is tasked with coordinating oncology activities across all divisions of the FDA, and ensuring collaboration between the agency, the National Cancer Institute and other cancer-related organizations within and outside the government.