GOP Senators Hope To Pass Flu Vaccine Liability Protections
Some Senate Republicans hope to add "sweeping language" that would provide flu vaccine manufacturers with liability protections to the "must-pass" fiscal year 2006 defense appropriations bill (HR 2863), a move that has "sparked outrage from Democrats and consumer advocates," USA Today reports.
Lawmakers on Wednesday continued to discuss the details of the liability protection provision, which Senate Majority Leader Bill Frist (R-Tenn.) supports. One version of the provision would allow patients injured by flu vaccines to file lawsuits against manufacturers only in cases in which they could prove misconduct.
Amy Call, a spokesperson for Frist, said the Senate could vote on the provision as early as Friday (Stone, USA Today, 12/15).
According to the Christian Science Monitor, consumer and open-government groups have "succeeded in slowing the progress" of a bill (S 1873) introduced by Sen. Richard Burr (R-N.C.) to establish a Biomedical Advanced Research and Development Agency that included similar liability protections.
Christopher-Paul Milne, assistant director of the Tufts University Center for the Study of Drug Development, said that the participation of pharmaceutical companies in vaccine development is important because they "have the resources and the expertise and the manufacturing capacity to get (development of new vaccines) done in a short period of time" (Lamb, Christian Science Monitor, 12/15).
Bruce Gellin, director of the national vaccine program office at HHS, said, "We have heard in no uncertain terms that this is a show stopper for the (drug) industry." He added, "This is a new vaccine, and because of that, they feel uncomfortable" with vaccine production without liability protections.
Sen. Judd Gregg (R-N.H.) said that currently only four pharmaceutical companies produce flu vaccines, compared with 25 companies in the 1980s. He added, "Nobody's going to take the risk of running into the trial lawyers."
Sen. Edward Kennedy (D-Mass.) said, "They are trying to insert this outrageous giveaway to the drug industry ... without public scrutiny or debate," adding, "Congress should reject any backroom deal that gives a free pass to companies that act irresponsibly or denies fair compensation to injured patients."
According to Kennedy and consumer groups, a requirement that individuals injured by vaccines must prove willful misconduct to file lawsuits against manufacturers effectively would block compensation.
Opponents also have raised concerns that the provision could apply to any medication used to treat "epidemics," which could include conditions such as diabetes. In addition, opponents maintain that the federal government currently can protect vaccine manufacturers and that the government should treat individuals injured by flu vaccines similar to those injured by vaccines for measles, chicken pox or other childhood diseases (USA Today, 12/15).