Manufactoring and distribution in the biosciences is unique in its development and deployment of specialized technologies including cold storage, highly regulated monitoring, and automated drug distribution systems.

For more than a decade, BIO has called for open, transparent, and science-based dialogue regarding biosimilars. More recently, we played a leading role in the effort to establish a pathway for the approval of biosimilars. Many of our members are global leaders in the development and commercialization of biosimilars.

The drug discovery and development process involves researchers discovering new drugs through a variety of means including, testing molecular compounds to find possible beneficial effects against any of a large number of diseases or using existing treatments that have unanticipated effects. Once researchers identify a promising compound for development, they conduct experiments to gather information on how it is absorbed, distributed, metabolized, and excreted, the best dosage and a multitude of other factors.

The Food & Drug Administration (FDA) reviews all drugs before they enter the market. If a drug developer has evidence from its early tests and preclinical and clinical research that a drug is safe and effective for its intended use, the company can file an application to market the drug. The FDA thoroughly examines all submitted data on the drug and makes a decision to approve or not to approve it. In cases where FDA determines that a drug has been shown to be safe and effective for its intended use, it is then necessary to work with the applicant to develop and refine prescribing information.

Most medical treatments are designed for the "average patient " as "one-size-fits-all-approach," that is successful for some patients but not for others. Precision medicine, sometimes known as "personalized medicine" is an innovative approach to disease prevention and treatment that takes into account differences in people’s genes, environments and lifestyles. Advances in precision medicine have already led to powerful new discoveries and several new FDA-approved treatments that are tailored to specific characteristics of individuals, such as a person’s genetic makeup, or the genetic profile of an individual’s tumor.

The Prescription Drug User Fee Act (PDUFA) was originally enacted in 1992 and have been renewed ever since. This legislation authorizes the FDA to collect fees from companies that produce certain human drug and biological products. PDUFA established three types of user fees - application fees, establishment fees, and product fees. Since the passage of PDUFA, user fees have played an important role in expediting the drug approval process.

Find information about BIO's advocacy efforts related to patient access to innovative therapies and reimbursement policies for Federal, state and private markets.

Find information on policy issues related to vaccine innovation as well as the biotechnology sector's contribution to national biodefense preparedness.