TreesOfLife
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http://www.dddmag.com/coaxing-pharma-out-of-the-gate.aspx
Coaxing Pharma Out of the Gate
Drug Discovery & Development - June 01, 2005
Ted Agres
Deputy managing editor,
Washington Times
Expect a major fight this year in Congress over plans to expand on Project BioShield. Proposed new legislation would grant a raft of new incentives, such as patent extensions, liability protections, and additional tax credits, to pharmaceutical and biotech companies that develop countermeasures against bioterrorism agents.
Not surprisingly, the biotech and branded drug industries generally support the proposed incentives, whereas generic drug makers oppose them. But there appears to be enough support from all quarters to pass at least some incentives this year, particularly protection against liability exposure for companies developing bioterror therapies.
Major drug manufacturers say they need these and other measures before embarking on the costly and risky process of developing countermeasures for such agents as anthrax, smallpox, plague, and botulism. Generic drug manufacturers say some of the proposed incentives, especially patent term extensions, will delay access to more affordable medicines and increase prescription drug costs.
"It is outrageous that under the guise of homeland security, the [branded pharmaceuticals] industry is seeking patent extensions for everyday medicines at the expense of consumers, especially seniors and the uninsuredindividuals who need affordable, life-saving generic medicines the most," said Kathleen Jaeger, president of the Generic Pharmaceutical Association (GPhA), a trade association in Washington, D.C.
Two new pieces of legislation, both called BioShield II, would expand on the original Project BioShield, which was signed into law last July. While the earlier legislation guaranteed $5.6 billion to develop and stockpile new vaccines and countermeasures, industry executives have been largely sitting on the sidelines, awaiting additional measures to protect their companies from liability and to encourage more R&D through tax credits and patent term extensions.
"Large pharmaceutical companies have so far not been interested in BioShield because of fear of being sued" if they make a vaccine or drug that has adverse health effects, said Frank Rapoport, managing partner at McKenna Long & Aldridge, a law firm representing drug and biotech companies seeking government contracts.
Many of those hoped-for measures are included in new legislation being pushed by senators Joseph Lieberman (D-Conn.) and Orrin Hatch (R-Utah). Much of their bill is based on legislation they introduced last year but which failed to gain traction in Congress. That earlier bill, the Biological, Chemical, and Radiological Weapons Countermeasures Research Act (S. 666), included tax credits, intellectual property incentives, and liability protections.
The S. 666 bill also offered companies developing bioterror countermeasures patent extensions equal to the regulatory review period for their primary products. Companies would also receive tax credits to pursue countermeasures R&D, an important provision because not every new drug will make money, making patent extension less attractive for some.
Perhaps most controversial, the bill also offered a "wild card" extension of two years on an unrelated patent. So, if Pfizer successfully developed a BioShield vaccine for the government, it could receive a two-year patent extension on an unrelated drug of its choice.
The new version of the bill includes a watered down version of the wild card provision, Rapoport said. Several big pharmas have already backed away from the wild card provision and others are not taking a position on the matter, preferring to focus instead on liability protection and guaranteed purchase commitments from the government.
Another version of BioShield II is in the works. While the wild card patent extension is not included in S. 3, another patent provision is nearly as contentious. This provision would allow the government to reward manufacturers that develop a countermeasure from existing products. Up to two years additional market exclusivity could be granted for a product that is developed as a countermeasure to compensate the company for directing their resources in this direction.
"This type of incentive will encourage manufacturers to step forward in a crisis and will help them recoup their losses from diverting their research and manufacturing efforts from more profitable products," Gregg said. But the GPhA's Jaeger opposes the provision. "Commonly prescribed drugs to treat headaches, nausea, and depression would be eligible for patent extensions with minimal testing performed by the brand manufacturer," she said.
One area where the generics and branded industries agree is support for additional liability lawsuit protections to companies developing bioterror countermeasures. In an emergency, these products could be made available without having gone through clinical trials or other human subjects testing, with safety and efficacy data derived primarily from animal trials. Existing law is "woefully inadequate to address the practical realities of potential litigation facing providers of countermeasures," Gregg said. Under both versions of BioShield II, liability protections would be extended to new bioterror-related products.
"It's not unreasonable that in five years we'll see 10 to 15% of the defense budget dedicated to public health and bioweapons," Rapoport predicts. "We're not talking about just $5.6 billion from BioShield. If the defense budget is $400 billion, we're talking $40 to $60 billion and the creation of a new industry."
Building this strong biodefense sector is imperative, Gregg said. "We have an obligation to be prepared for the worst threat. Maybe that next [bioterror] attack will never come. Or maybe it will come tomorrow. But we have an obligation to make sure that we have done all we can to be prepared and protected if our luck runs out," Gregg said.
http://www.dddmag.com/coaxing-pharma-out-of-the-gate.aspx
Coaxing Pharma Out of the Gate
Drug Discovery & Development - June 01, 2005
Ted Agres
Deputy managing editor,
Washington Times
Expect a major fight this year in Congress over plans to expand on Project BioShield. Proposed new legislation would grant a raft of new incentives, such as patent extensions, liability protections, and additional tax credits, to pharmaceutical and biotech companies that develop countermeasures against bioterrorism agents.
Not surprisingly, the biotech and branded drug industries generally support the proposed incentives, whereas generic drug makers oppose them. But there appears to be enough support from all quarters to pass at least some incentives this year, particularly protection against liability exposure for companies developing bioterror therapies.
"It is outrageous that under the guise of homeland security, the [branded pharmaceuticals] industry is seeking patent extensions for everyday medicines at the expense of consumers, especially seniors and the uninsuredindividuals who need affordable, life-saving generic medicines the most," said Kathleen Jaeger, president of the Generic Pharmaceutical Association (GPhA), a trade association in Washington, D.C.
Two new pieces of legislation, both called BioShield II, would expand on the original Project BioShield, which was signed into law last July. While the earlier legislation guaranteed $5.6 billion to develop and stockpile new vaccines and countermeasures, industry executives have been largely sitting on the sidelines, awaiting additional measures to protect their companies from liability and to encourage more R&D through tax credits and patent term extensions.
"Large pharmaceutical companies have so far not been interested in BioShield because of fear of being sued" if they make a vaccine or drug that has adverse health effects, said Frank Rapoport, managing partner at McKenna Long & Aldridge, a law firm representing drug and biotech companies seeking government contracts.
Many of those hoped-for measures are included in new legislation being pushed by senators Joseph Lieberman (D-Conn.) and Orrin Hatch (R-Utah). Much of their bill is based on legislation they introduced last year but which failed to gain traction in Congress. That earlier bill, the Biological, Chemical, and Radiological Weapons Countermeasures Research Act (S. 666), included tax credits, intellectual property incentives, and liability protections.
The S. 666 bill also offered companies developing bioterror countermeasures patent extensions equal to the regulatory review period for their primary products. Companies would also receive tax credits to pursue countermeasures R&D, an important provision because not every new drug will make money, making patent extension less attractive for some.
Perhaps most controversial, the bill also offered a "wild card" extension of two years on an unrelated patent. So, if Pfizer successfully developed a BioShield vaccine for the government, it could receive a two-year patent extension on an unrelated drug of its choice.
The new version of the bill includes a watered down version of the wild card provision, Rapoport said. Several big pharmas have already backed away from the wild card provision and others are not taking a position on the matter, preferring to focus instead on liability protection and guaranteed purchase commitments from the government.
Another version of BioShield II is in the works. While the wild card patent extension is not included in S. 3, another patent provision is nearly as contentious. This provision would allow the government to reward manufacturers that develop a countermeasure from existing products. Up to two years additional market exclusivity could be granted for a product that is developed as a countermeasure to compensate the company for directing their resources in this direction.
"This type of incentive will encourage manufacturers to step forward in a crisis and will help them recoup their losses from diverting their research and manufacturing efforts from more profitable products," Gregg said. But the GPhA's Jaeger opposes the provision. "Commonly prescribed drugs to treat headaches, nausea, and depression would be eligible for patent extensions with minimal testing performed by the brand manufacturer," she said.
One area where the generics and branded industries agree is support for additional liability lawsuit protections to companies developing bioterror countermeasures. In an emergency, these products could be made available without having gone through clinical trials or other human subjects testing, with safety and efficacy data derived primarily from animal trials. Existing law is "woefully inadequate to address the practical realities of potential litigation facing providers of countermeasures," Gregg said. Under both versions of BioShield II, liability protections would be extended to new bioterror-related products.
"It's not unreasonable that in five years we'll see 10 to 15% of the defense budget dedicated to public health and bioweapons," Rapoport predicts. "We're not talking about just $5.6 billion from BioShield. If the defense budget is $400 billion, we're talking $40 to $60 billion and the creation of a new industry."
Building this strong biodefense sector is imperative, Gregg said. "We have an obligation to be prepared for the worst threat. Maybe that next [bioterror] attack will never come. Or maybe it will come tomorrow. But we have an obligation to make sure that we have done all we can to be prepared and protected if our luck runs out," Gregg said.