Senate Republicans To Introduce Bill To Provide Incentives To Produce Avian Flu Treatments

Senate Republicans soon are expected to introduce a measure that would provide $1 billion in incentives for pharmaceutical companies to produce treatments in the event of a bioterrorist attack or epidemic of disease such as avian flu, the Philadelphia Inquirer reports. The bill, written by Sen. Richard Burr (R-N.C.), would earmark $1 billion for grants and other assistance for pharmaceutical companies to help fund the early developmental stages for new medications.

The bill also would create a new HHS office to coordinate the development of treatments to protect against chemical, biological, nuclear or radiological attacks. HHS would be authorized to determine whether the medicine is a "qualified countermeasure," making it eligible for reimbursement and other incentives, according to the Inquirer.

Qualified treatments would be given longer patent protection than other medications. In addition, the bill would create legal protections for manufacturers of qualified medicines in case of adverse reactions. The protections would not apply in cases in which the manufacturers "flagrantly ignored evidence that the drug or device posed a hazard or in some way acted illegally," the Inquirer reports.

Generic drug makers and health insurers have criticized the proposal because they say the patent protections could increase the cost of prescription drugs. "The bad news is (the patent provisions) will needlessly delay affordable medicines from coming to market and exacerbate the problem of high health care costs for all Americans," Annette Guarisco, chair of the Coalition for a Competitive Pharmaceutical Market, said.

Kathleen Jaeger, president of the Generic Pharmaceutical Association, said the bill would restrict the manufacture of generic drugs, raising overall costs.

According to the Inquirer, several bills designed to provide incentives to drug makers to manufacture such medicines have failed in the Senate in recent years, but lawyers representing pharmaceutical companies predict the new legislation will move quickly through Congress because of increased concern over avian flu (Mondics, Philadelphia Inquirer, 10/16).

In related news, Sen. Chuck Schumer (D-N.Y.) on Sunday said Roche Holding's patent on Tamiflu -- the medication considered most effective against avian flu -- should be suspended to allow generic drug companies to manufacture additional doses. Roche has a patent on Tamiflu until 2016.

Schumer has requested that Roche suspend its patent to allow other companies to make enough doses to treat 40% to 50% of the U.S. population. Roche has said it could take at least three years to make that much Tamiflu, but Schumer said generic drug makers could reach that level of production in months (Saruk/McAuliff, New York Daily News, 10/17). Schumer said he will give Roche 30 days to suspend its patent before introducing legislation that would force the move (Leszkiewicz/Greene, New York Post, 10/17).

Existing law allows the U.S. to suspend a patent in an emergency, and Schumer's bill would put the law into effect for Tamiflu and compensate Roche. "As the Asian flu closes in on the United States, we don't have the tools in place to fight it," Schumer said, adding, "Roche is very simply putting profits ahead of world safety." Roche could not be reached for comment (New York Daily News, 10/17).

HHS Secretary Mike Leavitt on Saturday said his recent tour of Cambodia, Laos, Thailand and Vietnam -- four nations affected by avian flu -- has given him a realistic view of the challenges facing Asian efforts to contain the virus in the event of an outbreak.

"Can we create a network of surveillance sufficient enough to find the spark when it happens, to get there fast enough?" Leavitt asked. He said, "The chances of that happening are not good." Leavitt said he will use the information he gained from his trip to improve U.S. preparedness, noting that U.S. residents are not prepared for the possibility of a quarantine if a pandemic occurs.

"People have not exercised adequate personal preparedness to last more than three or four days in their normal environment without going to the store," he said, adding, "What's the responsibility of communities? What's the responsibility of families?" (AP/Baltimore Sun, 10/16).

The New York Times on Sunday published an excerpt of a draft of the U.S. pandemic flu preparedness plan, which the paper reportedly obtained prior to its release this week.

The 381-page draft, dated Sept. 30, includes a section titled "Pandemic Scenario -- Origin and Initial Spread," in which the authors describe a flu pandemic spreading from a village in Asia to the U.S. "where it causes panic and as many as 1.9 million deaths," the Times reports (New York Times, 10/16).