[20190517]IF11217_药品定价与法律：监管排他性.pdf

https:/crsreports.congress.gov May 17, 2019Drug Pricing and the Law: Regulatory ExclusivitiesThe Food and Drug Administration (FDA) generally must approve pharmaceutical products, such as drugs and biologics, before they can be marketed in the United States. To obtain approval of a new drug or biologic (i.e., the brand-name or reference product), the sponsor must submit to FDA data from clinical investigations demonstrating that the underlying product is safe and effective for its intended use. Conversely, a follow-on product, such as a generic drug or biosimilar, via an abbreviated process by relying upon the data generated to support approval of the reference product. In order to balance interests in competition with the countervailing interest in encouraging innovation, federal law establishes periods of regulatory exclusivity that limit FDAs ability to approve applications to market pharmaceutical products under certain circumstances. There are two general categories of regulatory exclusivity: (1) data exclusivity, which precludes applicants from relying on the reference products clinical data to demonstrate the safety and effectiveness of the follow-on product; and (2) market