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Smallpox Vaccine Injury Compensation

Description: This report discusses the Public Safety Officers’ Benefits Program, which provides for compensation of individuals injured by vaccinations given as part of a countermeasure plan declared by the Secretary of Health and Human Services in preparation for potential hostile activities involving the smallpox virus.
Date: June 13, 2003
Creator: Thaul, Susan
Partner: UNT Libraries Government Documents Department

FDA’s Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective

Description: The Food and Drug Administration (FDA) has approved for adult use many drugs never tested in children. Yet clinicians often prescribe them for children believing that the safety and effectiveness demonstrated with adults probably reasonably transfers to younger patients. The data show that this is not always true. To encourage industry to develop drugs and medical devices for pediatric use, Congress has established three programs. The Food and Drug Administration Amendments Act of 2007 (FDAAA, P.L. 110-85) reauthorized and strengthened two laws addressing drugs—the Best Pharmaceuticals for Children Act (BPCA) of 2002 and the Pediatric Research Equity Act (PREA) of 2003—and enacted a new law addressing devices—the Pediatric Medical Device Safety and Improvement Act (PMDSIA) of 2007. The historical approach of this report allows an understanding of how and why Congress took these steps.
Date: December 2, 2008
Creator: Thaul, Susan
Partner: UNT Libraries Government Documents Department

Pharmaceutical Supply Chain Security

Description: This report serves as a primer on pharmaceutical supply chain issues. It (1) describes the chain from manufacturer to patient, including where it is vulnerable; (2) summarizes current federal law, regulation, and FDA policies that Congress and the agency designed to protect the integrity of the final drug product, and indicates where those protections may falter; (3) notes state-level and professional association activities; and (4) discusses areas that Congress, FDA, and industry, health care, and patient stakeholders have suggested might be changed to increase the security of the pharmaceutical supply chain.
Date: October 31, 2013
Creator: Thaul, Susan
Partner: UNT Libraries Government Documents Department

Prescription Drug User Fee Act (PDUFA): 2017 Reauthorization as PDUFA VI

Description: This report discusses the Prescription Drug User Fee Act (PDUFA) and its reauthorization as PDUFA VI. The bill allows the FDA to collect fees from pharmaceutical companies to support the review process for human drug applications. The various stages of drafting and passing the bill as well as changes from the most recent PDUFA are included.
Date: June 8, 2017
Creator: Dabrowska, Agata & Thaul, Susan
Partner: UNT Libraries Government Documents Department

H.R. 6: The 21st Century Cures Act

Description: Report about H.R. 6, the 21st Century Cures Act, which would reauthorize the National Institutes of Health (NIH) through FY2018 and provide other funding to the agency through FY2020.
Date: July 8, 2015
Creator: Johnson, Judith A.; Thaul, Susan & Bagalman, Erin
Partner: UNT Libraries Government Documents Department

FDA Authorization Act of 2017 (FDARA, P.L. 115-52)

Description: This report presents an overview of the Food and Drug Administration Reauthorization Act (FDARA) of 2017 by title and section, providing a narrative context for each title, as well as a brief description of each section.
Date: September 21, 2017
Creator: Sarata, Amanda K.; Dabrowska, Agata; Johnson, Judith A. & Thaul, Susan
Partner: UNT Libraries Government Documents Department

Frequently Asked Questions About Prescription Drug Pricing and Policy

Description: This report will address frequently asked questions about government and private-sector policies that affect drug prices and availability. Among the prescription drug topics covered are federally funded research and development, regulation of direct-to-consumer advertising, legal restrictions on reimportation, and federal price negotiation. The report provides a broad overview of the issues as well as references to more in-depth CRS products. The appendixes provide references to relevant congressional hearings and documents (see Appendix A) and a directory of CRS prescription drug experts (see Appendix B).
Date: May 2, 2017
Creator: Kirchhoff, Suzanne M.; Johnson, Judith A. & Thaul, Susan
Partner: UNT Libraries Government Documents Department

FDA Human Medical Product User Fee Programs: In Brief

Description: This report discusses FDA human medical product user fees for prescription drugs, medical devices, generic drugs, and biosimilars which are charged to companies producing the products and make up a large portion of the FDA's revenues. User fees are authorized in legislation on a five-year cycle, with authority for their actual collection and expenditure provided each year through the annual appropriations process. Appendix A outlines various features of the user fee programs.
Date: November 21, 2017
Creator: Dabrowska, Agata; Johnson, Judith A.; Sarata, Amanda K. & Thaul, Susan
Partner: UNT Libraries Government Documents Department

The FDA 2009 Budget Request

Description: The Administration's FY2009 budget request of $2.4 billion for the Food and Drug Administration (FDA) would provide a 5.7% increase ($130 million) over FY2008. User fees would make up about 26% of the total amount requested and would account for 61% of the proposed increase. Budget documents indicate that the additional funding would provide for expanded activities to ensure the safety of foods and drugs, as well as to accelerate the availability of new medical products. About half of the requested increase would be used for cost-of-living pay increases, as opposed to new program activities.
Date: May 19, 2008
Creator: Johnson, Judith A.; Lister, Sarah A.; Porter, Donna V.; Smith, Pamela W.; Thaul, Susan & Williams, Erin D.
Partner: UNT Libraries Government Documents Department

The Food and Drug Administration Safety and Innovation Act (P.L. 112-144)

Description: This report provides a brief policy background narrative and an overview of provisions for each title of the Food and Drug Administration Safety and Innovation Act (FDASIA), P.L. 112-144. The legislation amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand the authority of the Food and Drug Administration (FDA) in performing its human drug, biological product, and medical device responsibilities.
Date: August 21, 2012
Creator: Thaul, Susan; Bagalman, Erin; Corby-Edwards, Amalia K.; Glassgold, Judith M.; Johnson, Judith A.; Lister, Sarah A. et al.
Partner: UNT Libraries Government Documents Department