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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 outsourcing, and patient and provider demand; and information on adverse events involving compounded drugs.
Date: May 23, 2013
Creator: Glassgold, Judith M.
Partner: UNT Libraries Government Documents Department

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.
Partner: UNT Libraries Government Documents Department

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.
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 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 possible alternatives.
Date: October 7, 2015
Creator: Thomas, John R.
Partner: UNT Libraries Government Documents Department

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.
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

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.
Partner: UNT Libraries Government Documents Department

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
Partner: UNT Libraries Government Documents Department

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
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

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 most attention.
Date: August 13, 2001
Creator: O’Sullivan, Jennifer
Partner: UNT Libraries Government Documents Department

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.
Partner: UNT Libraries Government Documents Department

Authorized Generic Pharmaceuticals: Effects on Innovation

Description: The practice of “authorized generics” has recently been the subject of considerable attention by the pharmaceutical industry, regulators, and members of Congress alike. An “authorized generic”–sometimes termed a “branded,” “flanking,” or “pseudo” generic–is a pharmaceutical that is marketed by or on behalf of a brand name drug company, but is sold under a generic name. Although the availability of an additional competitor in the generic drug market would appear to be favorable to consumers, authorized generics have nonetheless proven controversial. Some observers believe that authorized generics potentially discourage independent generic firms both from challenging drug patents and from selling their own products.
Date: August 8, 2006
Creator: Thomas, John R
Partner: UNT Libraries Government Documents Department

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.
Partner: UNT Libraries Government Documents Department

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.
Partner: UNT Libraries Government Documents Department

Follow-On Biologics: Intellectual Property and Innovation Issues

Description: This report reviews doctrinal and policy issues pertaining to follow-on biologics. The report first introduces the application of federal food and drug legislation to follow-on biologics. It next turns to the patent implications of marketing follow-on biologics. Following this review of substantive law, the remainder of the report introduces innovation policy issues pertaining to follow-on biologics.
Date: August 3, 2009
Creator: Schacht, Wendy H. & Thomas, John R.
Partner: UNT Libraries Government Documents Department

FDA Regulation of Follow-On Biologics

Description: This report provides a brief introduction to the relevant law regarding follow-on biologics, the regulatory framework at the FDA, the scientific challenges for the FDA in considering the approval of follow-on biologics, and a description of the proposed legislation.
Date: February 24, 2009
Creator: Johnson, Judith A.
Partner: UNT Libraries Government Documents Department