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The Drug Price Competition and Patent Term Restoration Act (Public Law 98-417), informally known as the Hatch-Waxman Act, is a 1984 United States federal law which encourages the manufacture of generic drugs by the pharmaceutical industry and established the modern system of government generic drug regulation in the United States. Representative Henry Waxman of California and Senator Orrin Hatch of Utah sponsored the act. Hatch-Waxman amended the Federal Food, Drug, and Cosmetic Act. Section 505(j) of the Act, codified as 21 U.S.C. § 355(j), outlines the process for pharmaceutical manufacturers to file an Abbreviated New Drug Application (ANDA) for approval of a generic drug by the Food and Drug Administration (FDA). Section 505(j)(2)(A)(vii)(IV), often referred to as Paragraph IV, gives the first company to file an ANDA for a particular drug 180 days of exclusive rights to market the drug as the generic alternative to the branded drug. The 180 days begins on the first day of marketing the drug under the ANDA, if the paragraph IV certification is not challenged by the pioneer manufacturer. If the paragraph IV certification is challenged by the pioneer manufacturer, the 180 days begins on the date a court finds that,as required under paragraph IV, the patent of the pioneer manufacturer was not valid, enforceable, or not infringed. The Act enables a generic pharmaceutical manufacturer to develop copy of a patented innovator drug without duplicating the clinical and non-clinical studies or risking liability for patent infringement damages. The generic manufacturer must only demonstrate bioequivalence to the innovator. ==Relevant pharmaceutical industry background== There is not much legislative history on the Hatch-Waxman Act. However, because the bill was hard fought, there has been much written about it after the fact. Below is a brief history of the conditions surrounding the pharmaceutical industry and the prevalence of generic drugs that tie into goals and significance of this act. Prior to 1962, drugs were approved for safety only. In 1962, in the aftermath of the discovery that the use of a drug called thalidomide by pregnant women (mostly in Europe) had caused severe birth defects, Congress added a requirement that drug manufacturers also prove the effectiveness of the products before FDA could approve them for marketing. Thus, under these amendments to the Federal Food, Drug, and Cosmetic Act, new drugs had to be proven both safe and effective before they could be legally marketed. It is also important to note that for drugs approved prior to approval of Hatch Waxman, generic versions could be approved with a “paper” new drug application (NDA). This "abbreviated" NDA was based solely on published scientific or medical literature. Therefore, a generic manufacturer could get its drug approved by presenting academic articles about the chemical demonstrating that it was safe and effective. Despite this fact, it was found that in the years after 1962 there were 150 drugs that were off-patent, but for which there were no generics because generic companies simply would not spend the time and money doing the clinical trials to get to market, and that there were only fifteen “paper NDAs,” for post-1962 generics.〔Mossinghoff, Gerald. "Overview of the Hatch-Waxman Act and Its Impact on the Drug Development Process." Food and Drug Law Journal. 54. (1999): 187-194. Print.〕 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「Drug Price Competition and Patent Term Restoration Act」の詳細全文を読む スポンサード リンク
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