The Hatch-Waxman Act Quiz
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Questions and Answers

What is the Hatch-Waxman Act?

  • A 1984 US federal law that encourages the manufacture of generic drugs. (correct)
  • A 1974 US federal law that prohibits the manufacture of generic drugs.
  • A 1994 US federal law that regulates the sale of generic drugs.
  • A 2004 US federal law that limits the manufacture of generic drugs.

    • What did the Hatch-Waxman Act establish?

  • The modern system of government drug regulation in Asia
  • The modern system of government brand name drug regulation in the US.
  • The modern system of government drug regulation in Europe
  • The modern system of government generic drug regulation in the US. (correct)

    • What is an Abbreviated New Drug Application (ANDA)?

  • A new drug application for generic drugs. (correct)
  • An application for data exclusivity.
  • A new drug application for brand name drugs.
  • An application for patent extension.

    • What does the Hatch-Waxman Act provide for drug innovators?

    <p>A new five-year period of data exclusivity.</p> Signup and view all the answers

    How does the Hatch-Waxman Act facilitate the filing of ANDAs by generic companies?

    <p>By preventing the FDA from asking for anything other than information on how the drug will be manufactured</p> Signup and view all the answers

    What is a paragraph IV certification?

    <p>A certification that a patent is invalid or will not be infringed by the generic drug.</p> Signup and view all the answers

    What does the Hatch-Waxman Act promote?

    <p>Litigation between private parties.</p> Signup and view all the answers

    What percentage of prescriptions in the US were filled with generic drugs in 2012?

    <p>84%</p> Signup and view all the answers

    What issues have arisen with litigation incentivized by the Hatch-Waxman Act?

    <p>Settlements have been found to be invalid reverse payment patent settlement agreements.</p> Signup and view all the answers

    What has the FDA been slow to adopt regulations for?

    <p>The introduction of generic versions of biopharmaceutical drugs.</p> Signup and view all the answers

    Study Notes

    • The Hatch-Waxman Act is a 1984 US federal law that encourages the manufacture of generic drugs.
    • It established the modern system of government generic drug regulation in the US.
    • The Act amended the Federal Food, Drug, and Cosmetic Act and outlines the process for pharmaceutical manufacturers to file an Abbreviated New Drug Application (ANDA).
    • The Act gives drug innovators protection by introducing a new five-year period of data exclusivity and allowing the life of patents covering a drug to be extended.
    • The Act also facilitates the filing of ANDAs by generic companies by preventing the FDA from asking for anything other than information on how the drug will be manufactured.
    • The Act incentivizes companies to file paragraph IV certifications by rewarding the first company to file an ANDA with such a certification with 180 days of administrative exclusivity if their ANDA is approved.
    • The Act promoted litigation between private parties, with the innovator being prompted to commence patent enforcement litigation against the generic infringer.
    • The law has been successful in promoting the introduction of generics, with 84% of prescriptions in the US being filled with generic drugs in 2012.
    • There have been issues with litigation incentivized by the Act, with some settlements being found to be invalid reverse payment patent settlement agreements.
    • The FDA has been slow to adopt regulations for the introduction of generic versions of biopharmaceutical drugs (known as "biosimilars").

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    Description

    The Hatch-Waxman Act Quiz: Test Your Knowledge on the US Federal Law That Revolutionized the Generic Drug Industry. How much do you know about the process of Abbreviated New Drug Applications (ANDAs)? Do you understand the protections given to drug innovators and the incentives for generic companies under the Act? Take this quiz to learn more about the law that has greatly impacted the pharmaceutical industry in the US.

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