Thursday, February 17, 2005

What Bioshield II is Really About: Cynically Playing on

WASHINGTON, Feb. 8 /PRNewswire/ -- The Generic Pharmaceutical
> Association (GPhA) today issued a strong warning to the Senate that
> biodefense legislation (S. 3) in its current form would effectively
> extend patents for marketed drugs and delay access to more affordable
> generic medicines-unnecessarily increasing prescription drug costs to
> consumers, businesses, and government purchasers by tens of billions of
> dollars a year.
> "The legislation in its current form would provide enormous profits to
> brand companies by keeping affordable generic medicines off the market,
> leaving consumers and private and public purchasers to foot the
> multi-billion dollar bill," said GPhA President and CEO Kathleen
> Jaeger. "It is outrageous that under the guise of homeland security,
> the brand pharmaceutical industry is seeking patent extensions for
> everyday medicines at the expense of consumers, especially seniors and
> the uninsured-individuals who need affordable, life-saving generic
> medicines the most."
> S. 3 is intended to strengthen America's preparedness to bioterrorism
> through measures that accelerate the research, development and
> manufacture of novel countermeasure agents. It contains promising
> incentives, such as needed product liability protections, expanded tax
> incentives, and fast track FDA review of drug applications, which GPhA
> supports. However, it also includes provisions that would provide
> substantial and unnecessary windfalls to the brand pharmaceutical
> industry, impose a tremendous, and needless burden on the nation's
> health care system, and offer little enhancement to overall national
> security.
> Specifically, GPhA opposes provisions in the legislation that:
> -- Define a countermeasure so broadly that almost every drug in most
> people's medicine cabinets would qualify. Commonly prescribed drugs
> that
> treat headaches, nausea, and depression would be eligible for patent
> extensions with minimal testing performed by the brand manufacturer.
> Patent extensions on these products would put the healthcare system in
> crisis by adding tens of billions of dollars in expenditures on these
> already profitable drugs.
> -- Would allow for a "wild card" patent extension when a company has
> a countermeasure product approved (even for a secondary use to treat a
> common ailment like headaches). This "wild card" in effect transfers
> the awarded patent extension to any other product the company
> manufactures. For example, if Pfizer were to have a countermeasure
> labeling statement approved for an already existing product, it could
> reap up to two extra years of patent monopoly for a different
> blockbuster drug such as Viagra. The company also could license a
> product for which another drug company performed all the requisite
> research and development, yet still receive another wild card. The
> wild
> card could be applied at any time before patent expiration, creating
> uncertainty for generic companies to invest in the requisite
> development
> of affordable medicines.
> -- Allow for unlimited patent extensions per product. Under current
> law, only one patent can be extended for developing a novel drug
> product. Under S. 3, multiple patents claiming the brand drug can be
> extended, forcing consumers to pay monopoly prices for many years to
> come and keeping generics off the market.
> -- Would extend the patent terms of products that qualify as
> countermeasures up to the full amount of time from when the patent is
> issued until the product is approved. Current law balances innovation
> and access by providing only 5 years of the regulatory review period to
> be added to the patent's life. If a company were given the full review
> time under an unlimited regulatory review period, it could add a decade
> of patent exclusivity and monopoly pricing per brand product. Moreover,
> providing patent extension for the full development time is contrary to
> the intent of the goal of expediting research and development.
> -- Enable brand companies to be rewarded for the simple testing for
> new indications of currently marketed drugs, even if the federal
> government already has determined which everyday medicines are
> effective
> countermeasures for known bioterror threats. For instance, the Centers
> for Disease Control, the National Institutes of Health and Department
> of
> Defense provide a wealth of information on currently available products
> to use in case of exposure to many forms of biological and chemical
> agents. Since the research already has been performed at taxpayers'
> expense, there is no reason the brand pharmaceutical company that
> manufactures the product should be given any additional market
> protection on that product or any other product.
> "As drafted, S. 3 threatens the economic viability of the nation's
> health care system by penalizing new generic drug development, offering
> wild card exclusivity, and unnecessarily extending current patent
> terms.
> These proposals have been previously rejected by Congress as catering
> to
> special interests at the public's expense," said Jaeger. "These
> provisions will pose major economic challenges to already overburdened
> employers, insurers, consumers, and government programs such as
> Medicare
> and Medicaid. Given the growth in the number of uninsured Americans,
> serious deficits in Medicare and Medicaid programs, soaring health
> insurance premiums, and the numerous other crises facing the health
> care
> system, the financial and health care impact of S. 3 would be
> disastrous.
> "GPhA is looking forward to working with Congress to remove these
> onerous provisions from the bill and to help support the overall goal
> of
> securing America," Jaeger said. "No industry is more committed than the
> generic drug industry to protecting public safety, ensuring access to
> affordable, high-quality pharmaceuticals, and rewarding true
> innovation."
> GPhA represents the manufacturers and distributors of finished generic
> pharmaceuticals, manufacturers and distributors of bulk active
> pharmaceutical chemicals, and suppliers of other goods and services to
> the generic drug industry. Generics represent 51% of the total
> prescriptions dispensed in the United States, but less than 8% of all
> dollars spent on prescription drugs. The Generic Pharmaceutical
> Association is committed to improving lives for less. For further
> information, please contact GPhA at 703-647- 2480, or visit our web
> site
> at

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