An Unofficial Legislative History of the Biologics Price Competition and Innovation Act of 2009

Food and Drug Journal, Vol. 65, No. 4, 2010

149 Pages Posted: 17 Feb 2013

See all articles by Erika Lietzan

Erika Lietzan

University of Missouri School of Law

Jeffrey Elikan

Covington & Burling

Krista Carver

Covington & Burling

Date Written: February 17, 2013

Abstract

On March 23, 2010, President Obama signed into law the Biologics Price Competition and Innovation Act of 2009 (BPCIA) which created a regulatory pathway for, and scheme for litigation of patent issues relating to, “biosimilar” biological products. This article discusses the history of the BPCIA and explains its provisions. Section I provides background and a history of the regulation of drugs and biological products in the United States. Section II describes the growing interest in biosimilar approval from the early 2000s through September 2006, when the legislative debate began in earnest. Section III describes the legislative and stakeholder process from September 2006 to enactment, and section IV discusses the BPCIA in some detail. These sections show, and the conclusion in section V explains, that the regulatory and intellectual property issues addressed in the final 2010 legislation were debated, discussed, explored, and vetted by stakeholders — including the Food and Drug Administration (FDA), the Federal Trade Commission (FTC), Democrats and Republicans in both House and Senate, the United States Pharmacopoeia, the generic industry, the biosimilar industry, trade associations, professional organizations like the Drug Information Association (DIA), and European regulators — for (in some cases) as many as ten years. Moreover, as these sections also show, like the Hatch-Waxman amendments of 1984, the final legislation represents a true compromise of competing interests.

Keywords: biosimilars, BPCIA, biologics, Hatch-Waxman

Suggested Citation

Lietzan, Erika and Elikan, Jeffrey and Carver, Krista, An Unofficial Legislative History of the Biologics Price Competition and Innovation Act of 2009 (February 17, 2013). Food and Drug Journal, Vol. 65, No. 4, 2010. Available at SSRN: https://ssrn.com/abstract=2219873

Erika Lietzan (Contact Author)

University of Missouri School of Law ( email )

Missouri Avenue & Conley Avenue
Columbia, MO MO 65211
United States

Jeffrey Elikan

Covington & Burling

1201 Pennsylvania Avenue, N.W.
Washington, DC 20004-2401
United States

Krista Carver

Covington & Burling

1201 Pennsylvania Avenue, N.W.
Washington, DC 20004-2401
United States

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