Issues

Nearly 3.2 billion prescriptions are filled annually and decisions affecting drug regulation impact a majority of Americans.  With the 110^th Congress facing a number of bills on enhancing drug safety and strengthening the Food and Drug Administration (FDA), the Committee came together to ensure the voices of scientists, physicians, and patients are heard in this important debate.

We all want safer drugs, but what are the best ways to improve safety without severely reducing patient access, decreasing quality and options of treatments, placing undue burden on FDA, or further increasing the high price of medication?

Summary Recommendations

• Continually and simultaneously evaluate safety and efficacy when determining public access to, and marketing of, new products.

• A systematic approach to safety surveillance should be established to routinely probe a variety of existing healthcare databases in order to identify and describe post-market safety and efficacy signals associated with new drugs.

•  IT advancements and increased personnel and training are needed to enhance post-market safety surveillance and product review.

• Advance current opportunities to develop new tools and scientific methods to identify signals of drug toxicity and efficacy in patients sooner.