Bill extends drug exclusivity

North Carolina’s newest U.S. senator is set to introduce controversial legislation next month that could lure major drug companies to the bioterrorism defense market.

Through BioShield II, which will revamp the original BioShield program enacted by Congress in July 2004, Richard Burr hopes to help pharmaceutical companies overcome the considerable risks involved in bioterrorism drug development.

Companies often run into roadblocks after funding runs out and before development is completed.

“Because of the cost of research and development, these people can’t see it through to the end,” Burr told a group of law enforcement officers, government officials and emergency first responders Thursday in Durham.

Burr, a Republican and chairman of the Senate subcommittee on bioterrorism and public health preparedness, hopes the bill will be on the Senate floor by January.

Michael Mair, a senior analyst for the Center for Biosecurity at the University of Pittsburgh Medical Center, said the first BioShield program primarily attracted small- to mid-size drug developers. Participation by larger companies, however, could aid the nation’s preparedness in case of an attack.

Burr said he hopes his legislation will provide a solution by giving drug companies extensions on their patents for the bioterrorism defense drugs they develop.

The new directive also could sidestep controversy surrounding a wild card patent extension provision introduced by Sen. Joseph Lieberman, D-Conn., in a BioShield bill in April.

Lieberman’s legislation, which would give drug companies the ability to extend their hold on a wider range of drugs, has generic drug makers up in arms.

“We do not support patent extensions because they would place the burden of the cost of BioShield on America’s sick and elderly,” said Andrea Hofelich, spokeswoman for the Generic Pharmaceutical Association, adding that generic drugs can cost 30 to 80 percent less than brand name equivalents.

Burr said his proposal would not cause prescription drug costs to rise, adding that he supports patent extensions only on products going through the BioShield program.

GPhA recommends several other provisions, including product liability protection, in lieu of patent extensions that Hofelich said would entice companies to biodefense development.

Hofelich said companies in general are wary of developing innovative treatments that could be used in the event of a mass catastrophe before they have gone through the entire testing process.

Mair said companies also prefer to err on the side of caution.

“With these products, you don’t know what your liability exposure is,” he said. “It’s hard to calculate it into your estimation on whether you want to move forward with a product.”

Burr admitted that patent extensions are not a panacea for the problems plaguing drug development.

He said he hopes to develop an agency or division to oversee the developments and grants, pulling funding if projects fall through. The supervision could cut down on the government culture that slows down the creation of new drugs.

“There is a cultural problem in the federal government,” he said. “We need to create a separate entity that that culture can’t permeate.”

Burr said he has free reign in developing the legislation but has been meeting with White House officials and others to get the bill ready by September.

The nation is a global player, making diseases like the avian flu potential terrorist threats, he said.

“We are one airplane ride away from finding something in the United States that was half a world away.”

Assistant State & National Editor Erin Gibson contributed to this article.

Contact the State & National Editor at stntdesk@unc.edu.