House Healthcare-Reform Bill Includes Eshoo Amendment

The Energy and Commerce Committee of the US House of Representatives approved H.R. 3200, America’s Affordable Health Choices Act, on July 31, 2009. The bill is intended to protect consumers, foster competition between insurance plans, and expand access to high-quality, affordable healthcare.
 
H.R. 3200 includes the Pathway for Biosimilars amendment, which the committee agreed to by a 47–11 vote. The amendment, introduced by Rep. Anna Eshoo (D-CA), creates a procedure for the regulatory approval of biosimilars (i.e., follow-on biological drugs) and states that “approval of an application under this subsection may not be made effective by the Secretary until the date that is 12 years after the date on which the reference product was first licensed under subsection (a).”
 
The approved amendment “strikes the appropriate balance among ensuring patient safety, expanding competition, reducing costs, and providing necessary and fair incentives that will provide for continued biomedical innovation,” said Jim Greenwood, president and CEO of the Biotechnology Industry Organization, in a statement praising the Committee vote.
 
A majority of senators voted for a similar amendment offered by Sen. Orrin Hatch (R-UT), Sen. Mike Enzi (R-WY), and Sen. Kay Hagan (D-NC) in the recent markup of healthcare-reform legislation in the Senate Health, Education, Labor, and Pensions Committee, said Greenwood in the statement. The Hatch amendment also establishes an approval pathway for biosimilars and includes a 12-year exclusivity period.
 
The Eshoo amendment “undermines the best chance Congress has to provide a market-based approach to moderate the cost growth in the most rapidly inflating, highest-cost element of the pharmaceutical industry-biotech drug products-and, ultimately, increase access to affordable, life-saving medicines,” said Kathleen Jaeger, president and CEO of the Generic Pharmaceutical Association (GPhA), in a press release. The absence of a “reasonable and proven successful period of market exclusivity” would prevent the generic biopharmaceutical industry from introducing competition into the market, Jaeger said.
 
Two days before the House Committee’s vote, President Obama restated his preference for a seven-year exclusivity period during a town hall meeting in North Carolina. GPhA will seek to cooperate with Obama, Rep. Henry Waxman (D-CA), and other lawmakers to seek a compromise on market exclusivity, Jaeger said in the statement.
 
See related Pharm Tech articles:
 
BIO–1, GPhA–0 (blog post)

FTC Report on Follow-on Biologics Sparks Congressional Debate (ePT newsletter)

What is Fair for Drug Exclusivity? (blog post)

Charting a Pathway to Follow-On Biologics (Pharm Tech)