[20190117]IF11075_FDA和药品价格：促进获得非专利药物 .pdf

https:/crsreports.congress.gov January 17, 2019FDA and Drug Prices: Facilitating Access to Generic Drugs A variety of proposals to address high drug prices have been introduced in legislation and by the Trump Administration in its blueprint to lower drug prices. According to a Food and Drug Administration (FDA) analysis, the price of a drug is associated with the number of generic manufacturers on the market. As such, absent new legislation, FDAthe primary federal regulator of prescription drugscan help reduce drug prices indirectly by facilitating competition. This In Focus describes selected FDA actions intended to lower drug prices through generic competition, and considerations for the 116th Congress. Proposals that would not involve FDA (e.g., price negotiation under Medicare) are not discussed. Prescription Drug Regulation Before a new drug may be marketed in the United States, it must be approved by FDA. To obtain approval, the sponsor (generally the manufacturer) must submit to FDA a new drug application (NDA) containing, among other things, data from clinical trials. The Federal Food, Drug, and Cosmetic Act (FFDCA) specifies the required contents of an NDA, provides for t