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open access

Patents and Drug Importation

Description: This report explores the intellectual property laws and policies concerning the parallel importation of patented pharmaceuticals into the United States.
Date: June 1, 2007
Creator: Thomas, John R.
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

Prescription Drug Coverage Under Medicaid

Description: Medicaid is a joint federal-state entitlement program that pays for medical services on behalf of certain groups of low-income persons. It is the third largest social program in the federal budget, exceeded only by Social Security and Medicare and is typically the second largest spending item for states. This report discusses prescription drug policies under the program.
Date: February 21, 2006
Creator: Hearne, Jean
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

Pharmaceutical Patent Litigation Settlements: Implications for Competition and Innovation

Description: This report introduces and analyzes innovation policy issues concerning pharmaceutical patent litigation settlements, including pharmaceutical patent litigation procedures under the Hatch-Waxman Act, the concept of reverse payment settlements, the status of reverse payment settlements under the antitrust laws, and congressional issues and alternatives.
Date: January 20, 2011
Creator: Thomas, John R.
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

Prescription Drug Coverage Under Medicaid

Description: Medicaid is a joint federal-state entitlement program that pays for medical services on behalf of certain groups of low-income persons. It is the third largest social program in the federal budget, exceeded only by Social Security and Medicare and is typically the second largest spending item for states. This report discusses prescription drug policies under the program.
Date: February 6, 2008
Creator: Hearne, Jean
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

Pharmaceutical Patent-Antitrust: Reverse Payment Settlements and Product Hopping

Description: This report introduces and analyzes innovation and competition policy issues associated with the pharmaceutical industry. It begins with a review of the Hatch-Waxman Act and its implications upon the availability of generic substitutes for brand-name medications. The report then turns to a basic review of the antitrust law. It then addresses judicial developments with respect to reverse payment settlements and product hopping. The report closes with a summary of congressional issues and possibl… more
Date: October 7, 2015
Creator: Thomas, John R.
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

Medicare: Selected Prescription Drug Proposals in the 107th Congress

Description: Medicare, the nationwide health insurance program for the aged and disabled, does not cover most outpatient prescription drugs. On several occasions, the Congress has considered providing coverage for at least a portion of beneficiaries’ drug costs. The issue received renewed attention in the 106th Congress. However, there was no consensus on how the coverage should be structured. This report provides a side-by-side comparison of bills introduced in the 107th Congress that have received the mos… more
Date: August 13, 2001
Creator: O'Sullivan, Jennifer
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

The FDA FY2009 Budget

Description: This report discusses the Food and Drug Administration's (FDA's) FY2009 budget request of $2.676 billion that would provide a 17.9% increase ($406 million) over FY2008. It includes an overview and breakdowns for specific programs: Foods Program, Human Drugs Program, Biologics program, Animal Drugs and Feed Program, and the Devices and Radiological Health Program.
Date: August 25, 2008
Creator: Johnson, Judith A.; Lister, Sarah A. & Porter, Donna V.
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

Update of "All Eyes on Allergan: Drug Company's Unprecedented Move Raises Questions for Patent and Drug Law (Part 1)"

Description: This report is an update of a previous report discussing the case of "Allergan Inc. v. Teva Pharmaceuticals USA Inc." which deals with patent law and the rights of brand-name pharmaceutical companies and generic pharmaceutical companies as well as Native American tribes sovereign rights because the St. Regis Mohawk Tribe is a co-plaintiff in the case. The case is currently in the appeals process.
Date: March 16, 2018
Creator: Lewis, Caitlin Devereaux
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

FDA Risk Evaluation and Mitigation Strategies (REMS): Description and Effect on Generic Drug Development

Description: This report provides a brief history of FDA drug regulation, describes FDA's early risk management programs, and focuses on the agency's current risk management authorities, specifically risk evaluation and mitigation strategies (REMS). The report also discusses issues that have arisen as a result of REMS, particularly the impact on generic drug competition. While this report generally focuses on REMS in the context of generic drug development, the issues discussed are also relevant to biologic… more
Date: March 16, 2018
Creator: Dabrowska, Agata
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

Compounded Drugs

Description: This report provides background information on compounded drugs (CDs) and nontraditional compounding pharmacies relevant to policy discussions. This includes an overview of the 2012 fungal meningitis outbreak; recent recalls of compounded drugs; definitions of traditional compounding and nontraditional compounding; information on the CDs produced and by whom; information on the demand for nontraditional compounding, including the role of shortages of sterile injectable drugs, hospital outsourci… more
Date: May 23, 2013
Creator: Glassgold, Judith M.
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

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 congre… more
Date: May 2, 2017
Creator: Kirchhoff, Suzanne M.; Johnson, Judith A. & Thaul, Susan
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

Regulatory Exclusivity Reform in the 115th Congress

Description: This report introduces the various regulatory exclusivities that protect certain medicines from marketplace competition for a set period of time and then describes pertinent legislation in the 115th Congress addressing them.
Date: September 15, 2017
Creator: Thomas, John R.
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

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
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

FDA Risk Evaluation and Mitigation Strategies (REMS): Description and Effect on Generic Drug Development

Description: This report provides a brief history of FDA drug regulation, describes FDA's early risk management programs, and focuses on the agency's current risk management authorities, specifically risk evaluation and mitigation strategies (REMS). The report also discusses issues that have arisen as a result of REMS, particularly the impact on generic drug competition. It does not discuss antitrust issues raised by restricted distribution systems.
Date: April 11, 2017
Creator: Dabrowska, Agata
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

Patents and Drug Importation

Description: This report explores the intellectual property laws and policies concerning the parallel importation of patented pharmaceuticals into the United States.
Date: May 25, 2004
Creator: Thomas, John R.
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

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,… more
Date: October 31, 2013
Creator: Thaul, Susan
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

Patents and Drug Importation

Description: This report explores the intellectual property laws and policies concerning the parallel importation of patented pharmaceuticals into the United States.
Date: January 17, 2007
Creator: Thomas, John R.
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

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, … more
Date: December 2, 2008
Creator: Thaul, Susan
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

Influenza Antiviral Drugs and Patent Law Issues

Description: This report examines the role that intellectual property rights play in affecting the availability of a patented drug such as Tamiflu during public health crises. The report also explains one legal mechanism for increasing a patented drug’s production without the patent holder’s consent: governments may abrogate a pharmaceutical company’s patent rights by issuing compulsory licenses to other drug companies to manufacture generic versions of the drug.
Date: August 16, 2007
Creator: Yeh, Brian T.
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

Pharmaceutical Patent Litigation Settlements: Implications for Competition and Innovation

Description: This report introduces and analyzes innovation policy issues concerning pharmaceutical patent litigation settlements, including pharmaceutical patent litigation procedures under the Hatch-Waxman Act, the concept of reverse payment settlements, the status of reverse payment settlements under the antitrust laws, and congressional issues and alternatives.
Date: November 4, 2008
Creator: Thomas, John R.
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
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