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.
This report provides an overview of the regulatory structure of consumer finance under existing federal law before the Dodd-Frank Act went into effect, and examines arguments for modifying the regime in order to more effectively regulate consumer financial markets. It then analyzes how the CFP Act changes the legal structure, with a focus on the Bureau's organization; the entities and activities that fall (and do not fall) under the Bureau's supervisory, enforcement, and rulemaking authorities; the Bureau's general and specific rulemaking powers and procedures; and the Bureau's funding.
This report discusses products liability, which refers to the liability of a manufacturer or seller for injury caused by his product to the person or property of a buyer or third party. Legal developments starting in the 1960s, particularly the adoption of strict tort liability, have made it substantially easier for persons injured by defective products to recover damages.
Legislation has been proposed in the 107th Congress to combat the use and abuse of Ecstasy (MDMA) and other “club drugs.” In a 2001 survey, 12% of 12th graders reported ever having taken the drug. The Ecstasy Anti-Proliferation Act of 2000, enacted by the 106th Congress, directed the U.S. Sentencing Commission to increase penalties for Ecstasy offenses. As of March 2001, MDMA penalties became more severe than for powder cocaine but less severe than for heroin.
Under the American Jobs Creation Act of 2004 (AJCA, P.L. 108-357), the Internal Revenue Service (IRS) has acquired for the second time in its history the legal authority to hire private debt collection agencies (PCAs) to assist in the collection of certain individual tax debt. The grant of authority grew out of a proposal made by the Bush Administration in its budget request for the IRS in both FY2004 and FY2005. This report focuses on IRS’s current plan for hiring PCAs to collect delinquent individual taxes and the policy issues it raises. It begins with an examination of the scope of IRS’s authority to use PCAs under the AJCA and concludes with a discussion of the main issues for Congress as it oversees IRS’s efforts to implement and manage the private tax debt collection initiative. The report will be updated to reflect significant legislative action and new developments related to the initiative
Digital Rights Management (DRM) refers to the technology that copyright owners use to protect digital media. This report surveys several of the DRM bills that were introduced in the 107th and 108th Congresses. Generally, the bills are directed at two separate goals. One goal is to increase access to digitally-protected media for lawful purposes. The other attempts to thwart digital piracy and would do so by enhancing civil and criminal sanctions for digital (and traditional) copyright infringement and educating the public about the rights of copyright holders.
The purpose of this report is to explain why many of those who are least able to afford high drug costs are those who are most frequently charged the most. This report describes the basic economic theory underlying price differentiation and, in the context of the pharmaceutical market, analyzes the role and behavior of pharmacy benefit managers (PBMs), pharmaceutical manufacturers, and retail pharmacies, respectively. It also looks at a number of the criticisms that have been made of the practice of differential pricing. Finally, this report discusses various policy approaches aimed at assisting the elderly to purchase prescription drugs.
This report provides an overview of concerns about the health, safety, and quality of imported Chinese products, and implications for U.S.-China trade relations.
This report provides summaries of the federal laws and regulations particular to telemarketing, the establishment of a national do-not-call registry, and the options that are available to consumers to limit the calls that they receive from telemarketers and to report questionable telemarketing practices to local or federal authorities. The report also lists sources of additional information with addresses, phone numbers, and Internet sites (if available).
This report discusses the scope and nature of the safety challenge associated with the Firestone tire recall, and summarizes NHTSA’s defect investigations process (as of the end of the 106th Congress) and several relevant actions that NHTSA has taken to date. Second, some of the key efforts of Ford Motor Company (Ford) and Bridgestone/Firestone Inc. (Firestone) to deal with this challenge and associated economic impacts of the reported tire failures, and the recall are summarized
This report discusses the Robinson-Patman (R-P) Act, which makes it unlawful, with certain exceptions, to knowingly sell goods "in commerce," for use or sale within the United States, at differing prices to contemporaneous buyers of those goods.
This record provides information about The Hatch-Waxman Act: Proposed Legislative Changes Affecting Pharmaceutical Patents. Congressional interests in the cost of Pharmaceuticals have focused attention on several areas where the federal government has policies and programs.
This record provides information about The Hatch-Waxman Act: Proposed Legislative Changes Affecting Pharmaceutical Patents. Congressional interests in the cost of Pharmaceuticals have focused attention on several areas where the federal government has policies and programs.
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