10 Questions
What is the Hatch-Waxman Act?
A law that regulates the marketing of generic pharmaceuticals
What is the purpose of the Hatch-Waxman Act?
To address medical innovation and the growing cost of healthcare
What is an Abbreviated New Drug Application (ANDA)?
An application for market approval of a pharmaceutical
What is the Orange Book?
A list of all approved drug products
What is the purpose of the pediatric exclusivity period?
To encourage drug manufacturers to conduct research concerning the effectiveness of their drugs in children
What is the purpose of the Generic Animal Drug and Patent Term Restoration Act?
To extend term-restoration provisions of Hatch-Waxman Act to veterinary drugs and biological products
What is the goal of the GAIN Act?
To provide pharmaceutical and biotechnology companies with incentives to develop innovative antibiotics
What is the purpose of the expedited regulatory pathway for biosimilars and interchangeable biologics?
To decrease the time needed to bring biosimilars and interchangeable biologics to the marketplace
What is the purpose of the five-year exclusivity period for new chemical entities?
To protect a drug from competing applications for marketing approval under specified conditions
What is the purpose of the patent term extension?
To compensate for regulatory approval delays
Study Notes
- The Hatch-Waxman Act addresses medical innovation and the growing cost of healthcare.
- The act established practices to facilitate the marketing of generic pharmaceuticals while providing brand-name firms with incentives to innovate.
- The act includes an expedited generic regulatory approval procedure, a patent term extension to compensate for regulatory approval delays, and a statutory exemption from patent infringement for firms seeking regulatory approval.
- The act also created specialized infringement litigation procedures with respect to certain pharmaceutical patents.
- The act established periods of "regulatory exclusivity" that protect an approved drug from competing applications for marketing approval under specified conditions.
- The FDA evaluates the safety and efficacy of new drugs through clinical investigations.
- Generic drug companies must prove their products are bioequivalent to the brand-name drug.
- Some brand-name firms have refused to sell samples of their drugs to generic firms for use in developing competing products.
- Authorized generics may discourage independent generic firms from challenging drug patents and selling their own generic products.
- Congress has expressed interest in both medical innovation and the growing cost of health care, and potential legislative issues remain for consideration.
- Clinical trials are carried out in three phases to determine a drug's safety and effectiveness.
- A New Drug Application (NDA) is submitted to the FDA for evaluation after clinical testing is complete.
- The FDA considers clinical trial results, manufacturing processes, and animal studies when reviewing an NDA.
- FDA approval of an NDA allows a drug to be marketed to the public.
- The Hatch-Waxman Act of 1984 governs the mechanisms through which a potential generic manufacturer may obtain marketing approval on a drug that has been patented by another.
- The Hatch-Waxman Act includes provisions that permit manufacturers of generic drugs to gain FDA marketing approval by relying on safety and efficacy data from the brand-name firm's NDA.
- The Hatch-Waxman Act created a statutory exemption from certain claims of patent infringement.
- The statutory exemption allows generic manufacturers to commence work on a generic version of an approved drug any time during the life of the patent, so long as that work furthers compliance with FDA regulations.
- Prior to the Hatch-Waxman Act, generic drug manufacturers had to file their own NDA in order to market their drug.
- The approval of a generic drug was a costly, duplicative, and time-consuming process prior to the Hatch-Waxman Act.
- The Hatch-Waxman Act of 1984 was created to balance the interests of drug innovators and generic drug manufacturers.
- The Act established a new type of application for market approval of a pharmaceutical called an "Abbreviated New Drug Application" (ANDA).
- ANDA allows a generic drug manufacturer to rely upon the safety and efficacy data developed by the original manufacturer.
- The Orange Book lists all approved drug products and plays a role in the resolution of patent disputes.
- The Hatch-Waxman Act requires each holder of an approved NDA to list pertinent patents it believes would be infringed if a generic drug were marketed before the expiration of these patents.
- The Act provides for the extension of patent term for pharmaceutical patents, if the patent holder is entitled to have restored to the patent term one-half of the time between the IND application and the submission of an NDA.
- The Hatch-Waxman Act includes provisions that create regulatory exclusivity for certain FDA-approved drugs.
- The Act established a five-year exclusivity that is available to drugs that qualify as a new chemical entity (NCE).
- The Hatch-Waxman Act also provided for a three-year new clinical study exclusivity period.
- The Act's goal was to encourage drug innovation while also promoting affordable access to generic drugs.
- The Hatch-Waxman Act provides exclusivity periods for new drugs and generic drugs.
- New clinical study exclusivity applies only to the use of the product supported by the new clinical study.
- The Generic Animal Drug and Patent Term Restoration Act extends term-restoration provisions of Hatch-Waxman Act to veterinary drugs and biological products.
- The FDA Modernization Act provides for a six-month "pediatric exclusivity" to encourage drug manufacturers to conduct research concerning the effectiveness of their drugs in children.
- The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 permits no more than one 30-month stay on FDA approval of drugs for which patents are listed in the Orange Book.
- The Biologics Price Competition and Innovation Act (BPCIA) created an expedited regulatory pathway for biosimilars and interchangeable biologics.
- The BPCIA established regulatory exclusivities that are available to brand-name and follow-on firms.
- The GAIN Act of 2012 allows the FDA to designate a drug as a "qualified infectious disease product" (QIDP) and adds five years to the term of the new chemical entity, new clinical study, and orphan exclusivities for any QIDP.
- The GAIN Act was enacted to provide pharmaceutical and biotechnology companies with incentives to develop innovative antibiotics.
- The Hatch-Waxman Act and subsequent legislation aim to decrease the time needed to bring generic pharmaceuticals to the marketplace and increase the number of pharmaceuticals available for children.
This quiz tests your knowledge on the Hatch-Waxman Act and subsequent legislation that govern the approval and marketing of pharmaceuticals in the United States. You will learn about the different phases of clinical trials, the role of the FDA in approving new drugs, and the mechanisms through which generic drug manufacturers can obtain marketing approval on a patented drug. Additionally, you will explore the various provisions of the Hatch-Waxman Act, including regulatory exclusivity, patent infringement litigation, and the creation of an Abbreviated
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