TITLE

A SAFE HARBOR FOR DRUGS MADE OFFSHORE: THE FEDERAL CIRCUIT RENDERS THE BOLAR AMENDMENT AVAILABLE IN � 337 ACTIONS IN AMGEN V. U.S. INTERNATIONAL TRADE COMMISSION

AUTHOR(S)
Sheehan, Teige P.
PUB. DATE
February 2010
SOURCE
Albany Law Review;2010, Vol. 73 Issue 1, p329
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
The article focuses on the application of the Bolar Amendment of the Hatch-Waxman Act inspection of exported medicines from the U.S. through the Amgen v. U.S. International Trade Commission (ITC) court case in April 2009. The case emphasized that the ITC must probe on whether the drugs are exported by drug manufacturers approved by the U.S. Food and Drug Administration. The article concludes that the Bolar Amendment is essential to providing a trade protection from infringement lawsuits.
ACCESSION #
54020817

 

Related Articles

  • US FDA penal actions likely to hit pharma exports growth.  // FRPT- Chemical Snapshot;5/4/2014, p6 

    The article reports on the potential impact of the import alerts by the U.S. Food and Drug Administration (FDA) against medicines produced by several large Indian pharmaceutical companies on pharmaceutical exports from India. It mentions large pharmaceutical players including Ranbaxy Inc.,...

  • Shire's replacement enzymes validate gene activation. Moran, Nuala // Nature Biotechnology;Nov2010, Vol. 28 Issue 11, p1139 

    The article offers information about the velaglucerase alfa, glucocerebrosidase (VPRIV) developed by Shire and was approved by the European Medicines Agency and the U.S. Food and Drug Administration. The gene-activation technology is used for the firm's enzyme replacement therapies, Replagal for...

  • Chinese Wall. Agres, Ted // Drug Discovery & Development;Apr2008, Vol. 11 Issue 4, p10 

    The article discusses the role of the U.S. Food and Drug Administration (FDA) in ensuring safety and quality of imported pharmaceutical products. It states that the country's government is likely to ask the Food and Drug Administration (FDA) to inspect overseas plants and other facilities that...

  • Punishing Parallels.  // Pharmaceutical Executive;Sep2000, Vol. 20 Issue 9, p42 

    Deals with the Pharmaceutical Research and Manufacturers of America's criticism of the legislation passed by the United States Food and Drug Administration (FDA) which allows parallel imports of pharmaceuticals. Proposed amendments to the FDA funding bill; Concern expressed about the bill.

  • Big Deal for Big Pharma.  // America;5/28/2007, Vol. 196 Issue 19, p4 

    The article reports on the United States Senate's approval of an amendment that effectively excludes American citizens from importing prescription drugs from abroad. The vote was 49 to 40. The U.S. Food and Drug Administration certification of imported medicines is required by the amendment. The...

  • FDA Actions.  // Clinical Cardiology Alert;Mar2009 Pharmacology Watch, p2 

    The article reports on the program launched by the U.S. Food & Drug Administration (FDA) to improve the safety of imported drugs to the U.S. The pilot program would allow drug manufacturers outside the U.S. to apply for 1 of 100 certifications, which would require that companies have a secure...

  • FDA's Supply Chain Pilot Program is Prepped for Launch. Serebrov, Mari // BioWorld Today;8/20/2013, Vol. 24 Issue 159, p1 

    The article reports on the planned launch by the U.S. Food and Drug Administration (FDA) of a two-year test run of its Secure Supply Chain Pilot Program (SSCPP). The agency expects up to 100 drug companies to participate in the program. The SSCPP is designed to expedite entry into the U.S. of...

  • Who's Making Medicine? Hightower, Jim // Progressive Populist;3/15/2009, Vol. 15 Issue 5, p3 

    In this article the author reflects on the regulation for drug makers in the U.S. He explains that not all medicines available for Americans were produced in the U.S. and cites the report in "New York Times," regarding China as the world's major supplier of medicine. He comments on the action of...

  • The AMA backs drug importation—sort of.  // Medical Economics;1/21/2005, Vol. 82 Issue 2, p16 

    Reports on the American Medical Association's adoption of a policy to support the importation of prescription drugs by wholesalers in the United States, but only if the products are approved by the U.S. Food and Drug Administration (FDA) and meet all other FDA requirements. Requirement that drug...

Share

Read the Article

Courtesy of VIRGINIA BEACH PUBLIC LIBRARY AND SYSTEM

Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics