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A Senate committee is drafting bioterrorism legislation that could be introduced as early as the fall to build upon the Project BioShield Act of 2004, which President Bush signed into law last year.
Two prominent House Democrats have introduced legislation that would require drug and device manufacturers to submit clinical trial results to a federally managed database.
New Hampshire has become the seventh state to pass a law allowing pharmacists to dispense Barr Pharmaceuticals’ emergency contraceptive (EC), Plan B, without a prescription — even as a decision on the national level is pending with the FDA.
State legislatures are sorting through more 500 separate bills and resolutions affecting the pharmaceutical industry, including proposals to reduce prescription drug spending through generic drug use and preferred drug lists, according to a new report.
The pharmaceutical industry would receive tax incentives and intellectual property protections for developing bioterror antidotes under new biodefense legislation introduced in the Senate.
The Medicare drug benefit will likely stoke pressure for new legislation requiring clinical studies comparing new drug products to those already on the market, according to a former top FDA official who opposes such a mandate in the preapproval stage.
A pair of U.S. senators is hoping the U.S. flu-vaccine shortage will refocus attention on legislation they are co-sponsoring that could establish a guaranteed market in the U.S. for the vaccine, as well as restore the country's vaccine-production capability.
The U.S. flu-vaccine crisis has spurred an organization representing infectious-disease specialists to urge the federal government to develop policies that will negate financial disincentives that have driven the majority of pharmaceutical companies from R&D on vaccines.
Some pharmaceutical industry observers say it is increasingly unlikely that lawmakers will pass drug importation legislation this year, despite a promise by Senate Majority Leader Bill Frist (R-Tenn.) to bring a bill to the Senate floor before the end of the 108th Congress.
The chairman of the Senate Finance Committee, which has partial legislative jurisdiction over the Medicare program, is stepping up his surveillance of drug companies that repeatedly violate corporate integrity agreements they have entered into with the agency.