U.S. House Passes Bioterrorism, Drug Review Bill
WASHINGTON - The U.S. House Wednesday overwhelmingly approved a bill to increase funding for bioterrorism preparedness by $4.6 billion and to renew the law under which prescription drugmakers pay "user fees" to the Food and Drug Administration to speed the drug review process, Reuters reports. The vote was 425-1.
The bioterrorism bill was originally passed by the House and Senate last December in slightly different versions. The final measure authorizes funding for state and local public health activities, for the federal government to stockpile drugs and vaccines to treat or prevent spread of microbes released by bioterrorists, and for hospitals to prepare for potential bioterror events.
Other portions of the bill would increase regulation of those who handle potential biotoxins, increase the ability of the FDA to inspect and quarantine potentially tainted food, and require community water systems to conduct vulnerability assessments and prepare emergency response plans.
The user fee portion of the bill would renew and increase user fees paid by brand-name drugmakers that have cut new drug approval times in half since their inception a decade ago. The new version of the "Prescription Drug User Fee Act," or PDUFA, would also boost funding for FDA to oversee prescription drug advertising and to conduct post-marketing surveillance of newly approved drugs.
The bioterrorism bill was originally passed by the House and Senate last December in slightly different versions. The final measure authorizes funding for state and local public health activities, for the federal government to stockpile drugs and vaccines to treat or prevent spread of microbes released by bioterrorists, and for hospitals to prepare for potential bioterror events.
Other portions of the bill would increase regulation of those who handle potential biotoxins, increase the ability of the FDA to inspect and quarantine potentially tainted food, and require community water systems to conduct vulnerability assessments and prepare emergency response plans.
The user fee portion of the bill would renew and increase user fees paid by brand-name drugmakers that have cut new drug approval times in half since their inception a decade ago. The new version of the "Prescription Drug User Fee Act," or PDUFA, would also boost funding for FDA to oversee prescription drug advertising and to conduct post-marketing surveillance of newly approved drugs.