Senate Committee Considers Bill To Increase Preparedness for Bioterrorism, Disease Epidemics
The Senate Health, Education, Labor and Pensions Committee is marking up a bill (S 1873) that would create incentives for pharmaceutical companies to produce treatments in the event of a bioterrorist attack or epidemic of disease such as avian flu, CQ HealthBeat reports (CQ HealthBeat, 10/18).
The bill, sponsored 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. 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 dismissed evidence that the drug or device posed a hazard or in some way acted illegally (California Healthline, 10/17).
Senate Budget Committee Chair Judd Gregg (R-N.H.), a co-sponsor of the bill, said, "This legislation encourages the development and production of drugs and vaccines needed to protect the American public," adding, "The liability protection provisions eliminate the foremost barrier that companies face while trying to develop new and innovative countermeasures" (Manchester Union Leader, 10/19).
Senate Majority Leader Bill Frist (R-Tenn.) on Tuesday said that the Senate has placed $3.9 billion for flu preparedness in the fiscal year 2006 defense spending bill (HR 2863), with the allocated funding largely to be directed toward purchasing Roche's Tamiflu -- the medication considered most effective against avian flu.
Frist said, "I don't know exactly where the [Bush] administration is yet, and I don't know where the House is, but we're going to lead in this body" on the flu issue (CQ HealthBeat, 10/18).
Sen. Chuck Schumer (D-N.Y.) on Tuesday said he will introduce legislation within a month that would strip Roche's Tamiflu patent and allow other companies to produce the antiviral.
Meanwhile, Roche on Tuesday said it is willing to discuss licensing arrangements with other companies (Kaufman, Washington Post, 10/19). Roche in a statement said it is "prepared to discuss all available options" for expanding production of the drug, "including granting sublicenses ... with any government or private company who approach us to manufacture Tamiflu or collaborate with us in its manufacturing" (Whalen/Zamiska, Wall Street Journal, 10/19).
Schumer has called on Roche to allow five American companies to produce Tamiflu (Washington Post, 10/19). Roche has been accused by some critics of "unfairly monopolizing production at a time of potential crisis," with sales of the drug expected to quadruple this year to more than $1 billion, the Wall Street Journal reports (Wall Street Journal, 10/19).
With 40 countries "scrambling" to establish Tamiflu stockpiles, there has been "growing international pressure to ignore Roche's patent rights and manufacture inexpensive generic versions," the AP/Buffalo News reports (Elias, AP/Buffalo News, 10/19). In addition, the World Health Organization has indicated that the "lagging supply" of Tamiflu worldwide could justify breaking the company's patents, as allowed under international trade treaties during health emergencies, the Post reports (Washington Post, 10/19).
David Reddy, Roche's head of production and sales for Tamiflu, said the company had been approached by several Asian governments that wish to manufacture the drug. He added that the company is willing to discuss production with India-based pharmaceutical company Cipla, which has said it wants to make a generic version (Reuters/Los Angeles Times, 10/19).
India, Thailand and Taiwan have indicated they would like to make generic versions (Whalen/Zamiska, Wall Street Journal, 10/19). The Journal reports that if Roche is "serious, it will not only allow others to make Tamiflu, but also help them do it" (Murray, Wall Street Journal, 10/19).
Roche on Tuesday also said it has received permission from FDA to start using an additional manufacturing site in the U.S. to expand Tamiflu production.
The company said its Tamiflu production is expected to double this year and will double again by mid-2006 (Whalen/Zamiska, Wall Street Journal, 10/19).
The International Herald Tribune/New York Times on Wednesday examined how experts have been warning that "too little planning has gone into how to use the accumulated arsenal of medical weapons," and "it is not even clear how well they would work against" avian flu.
Laurie Garrett, head of the Global Health Program at the Council on Foreign Relations, said, "People are trying to do the right thing, but nobody knows what the right thing is." She added, "Every country feels like they have to do something, and so they order a quick technological fix."
Mike Ryan, director of influenza surveillance and response at WHO, said, "Preparedness is not just about stockpiling, it's about having an actual plan" (Rosenthal, International Herald Tribune/New York Times, 10/19).