Drug Price Competition And Patent Term Restoration Act Pdf
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- The Hatch-Waxman Act: Encouraging Innovation and Generic Drug Competition
Congress has for many years expressed interest in both medical innovation and the growing cost of health care. Through amendments to both the patent law and the food and drug law, the Hatch-Waxman Act established several practices intended to facilitate the marketing of generic pharmaceuticals while providing brand-name firms with incentives to innovate. The legislation also encourages brand-name firms to identify to the FDA any patents that cover their products. This latter assertion exposes the generic drug company to charges of patent infringement by the brand-name firm. These FDA-administered regulatory exclusivities typically operate alongside patents to block generic competition for a period of time.
Drug Price Competition and Patent Term Restoration Act
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U.S. Food and Drug Administration
What's on Practical Law? Show less Show more. Ask a question. Legislation that amended the Food, Drug, and Cosmetic Act to establish the Food and Drug Administration's FDA generic drug approval process and the patent litigation process for generic drugs. Key features include:. An abbreviated approval process for generic drugs using an abbreviated new drug application ANDA.
The Hatch-Waxman Amendments include provisions that involve patents and exclusivities related to new drug applications, and day exclusivity for certain ANDA applicants. As a general matter, the Food and Drug Administration FDA or the Agency has implemented these statutory provisions within the context of application-specific decisions. FDA may also, proactively, publish communications that it determines may be of general interest after addressing any concerns related to the disclosure of proprietary information.
U.S. Food and Drug Administration
Author s : Allen M. Sokal , Bart A. DOI : Congress carefully crafted the Hatch-Waxman Act to address two competing goals: to spur new pharmaceutical development and to encourage greater public access to generic drugs. To that end, the Act contains important provisions directed to fulfilling each goal, including provisions favorable to either branded drug or generic drug manufacturers.
Congressional interest in health-related issues has refocused attention on legislative efforts to provide both new as well as lower-cost pharmaceuticals for the marketplace. The act created several practices intended to facilitate the marketing of generic drugs while permitting brand name companies to recover a portion of their intellectual property rights lost during the pharmaceutical approval process. Twenty-five years later, the impact of the act on the pharmaceutical industry may have implications for current congressional efforts to facilitate the development of new, inventive products while reducing costs to consumers. The Generic Pharmaceutical Association points out that of 12, drugs listed in the Orange Book, 10, have generic substitutes available to consumers. Concurrently, the time to market for these generic products has decreased substantially.
A generic drug is, in essence, a bioequivalent version of a drug whose patent term and period of data exclusivity has expired. This means that the generic drug is similar or equivalent to the innovative drug in dosage form and strength, administration and intended use, safety and quality, and performance characteristics. Generic drugs are widely used in the U. In , generic medicines accounted for 56 percent of prescriptions dispensed in the United States, but less than 13 percent of every dollar spent on prescription drugs.
The Hatch-Waxman Act: Encouraging Innovation and Generic Drug Competition
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The Drug Price Competition and Patent Term Restoration Act Public Law , informally known as the Hatch-Waxman Act , is a United States federal law that encourages the manufacture of generic drugs by the pharmaceutical industry and established the modern system of government generic drug regulation in the United States. Although the Federal Food, Drug, and Cosmetic Act made it possible for generic companies to get regulatory approval for drugs by filing an Abbreviated New Drug Application ANDA , in the early s it became clear that very few generics were coming to market. Congress studied the issue and realized that under patent and regulatory law, it was easy for innovator companies to make it difficult for generic companies to successfully file ANDAs and that the regulatory pathway to get ANDAs approved was irregular and uncertain. In response, the Hatch-Waxman Act was negotiated and enacted. Section j of the Act, codified as 21 U.
Gerald F. Hogan, J. Recently enacted legislation involving patent terms and the approval of new generic equivalent drug products is described, and the law's potential repercussions are discussed. The Drug Price Competition and Patent Term Restoration Act of PL consists of two titles that affect introduction procedures and patent requirements for certain types of generic new drug products. Title I allows drug manufacturers to use an abbreviated new drug application when seeking approval to make generic copies of drug products that were approved by the FDA after Title II encourages drug manufacturers to assume the increased costs of research and development of certain products that were subject to premarketing clearance by restoring some of the time lost on patent life while the product was awaiting FDA approval. Legislative analysts continue to question whether the short-term gains of eased market access to the generic manufacturers will be outweighed by the long-term benefits of patent extensions to the pioneer drug companies.
The pharmaceutical industry has become a focal point in the last two decades due to the concern over rising drug prices. Today, brand name prescription drug.
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