Thursday, February 17, 2005

Judge warns Rumsfeld in anthrax case

Washington, DC, Feb. 15 (UPI) -- A judge in Washington has warned Defense
Secretary Donald Rumsfeld he could face contempt for ignoring a ruling on
Pentagon anthrax vaccinations.
In October, U.S. District Judge Emmet Sullivan largely struck down the U.S.
military's involuntary vaccinations for weaponized anthrax.

The judge said the program could not be administered unless individual
service members give "informed consent" to the vaccinations, President Bush
issues a specific waiver or the Food And Drug Administration properly
classifies a drug for use in the program.

A 1999 executive order by then President Bill Clinton required "informed
consent" before administering the vaccine.

Monday, Sullivan ordered "Donald H. Rumsfeld" to "show cause by Feb. 28" why
"he/or the government should not be held in contempt" for failing to follow
the earlier ruling.

Sullivan also ordered Pentagon employees and soldiers challenging the
program to respond to an emergency motion by the Pentagon asking that the
earlier injunction.
full story

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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