Sept. 24, 1997(Key vote)
Title: Prescription Drug bill
Vote Smart's Synopsis:
Vote to pass a bill that revises certain Food and Drug Administration regulations and creates a fast track approval program for drugs that treat life-threatening illnesses.
Permits the Secretary of Health and Human Services (HHS) to help increase the development, review, and approval of new drugs and biological products, named "fast track drugs," which are intended for the treatment of serious or life-threatening conditions.
Directs the Secretary of HHS to widely distribute rules concerning fast track drugs to doctors and patients, as well as related companies and organizations.
Allows any person to request a drug or device currently under study for the diagnosis, monitoring, or treatment of a serious disease, under certain conditions.
Authorizes the Secretary of HHS to work with other countries in order to reduce the burdens of regulation, and to achieve reciprocal arrangements with other countries.
Requires the Secretary of HHS to implement programs and policies to encourage collaboration between the Food and Drug Administration, National Institutes of Health, and other related Federal agencies.
Allows the Secretary of HHS to form a contract with an expert individual or organization to review, evaluate, and make recommendations about biological products.
Allows the Secretary of HHS to publish performance standards in the Federal Register.
Prohibits an individual from introducing any biological product into interstate commerce unless the product has a biologics license and is clearly labeled.
Increases the market exclusivity of pediatric drugs by 6 months when the Secretary of HHS has found such drugs to produce health benefits in the pediatric population.
Requires clear labels on all food containing a nutrient level that increases the risk of a health-related condition in the general population.