Physicians for Underserved Areas Act This bill modifies how a hospital's residency positions are redistributed after it closes for purposes of graduate medical education payments under Medicare. Under current law, if a hospital with an approved medical residency program closes, the Centers for Medicare & Medicaid Services (CMS) must redistribute the hospital's residency positions to other hospitals in the following order: (1) hospitals in the same core-based statistical area as the closed hospital, (2) hospitals in the same state as the closed hospital, (3) hospitals in the same region of the country as the closed hospital, and (4) other remaining hospitals. In order to receive the additional positions, hospitals must demonstrate a likelihood of filling the positions within three years. The bill removes the requirement that the CMS prioritize hospitals in the same region of the country as the closed hospital. It also requires hospitals to demonstrate a likelihood of (1) starting to use the positions within two years, and (2) filling the positions within five years.
Prompt Approval of Safe Generic Drugs ActThis bill authorizes the Food and Drug Administration (FDA) to approve certain applications to market a generic drug despite the omission of certain safety information from the generic drug's labeling.Specifically, the FDA may not deem an abbreviated application for approval of a generic drug ineligible for approval solely because the drug's labeling omits safety information that is protected under another drug's patent or exclusivity protections. Similarly, a drug that is approved under this bill may not be considered mislabeled for lacking such safety information.Generally, an abbreviated application, for the purposes of this bill, is one that (1) uses required information from studies not conducted by the applicant; or (2) seeks approval of a drug that is, for drug approval purposes, a duplicate of an already-approved drug (i.e., a generic drug). Currently, the labeling for such a generic drug must generally be identical to that of the already-approved drug. This bill provides an exception to that requirement under the specified circumstances. For any drug approved under this bill, the FDA must require the drug's labeling to include any safety information that is necessary to assure safe use.