Big Pharma Close to Hijacking Healthcare Reform with Biogeneric Drug Proposal

For Immediate Release
July 16, 2009

***Statement of Sarah Rimmington, Attorney, Essential Action, Access to Medicines Project***
For more information contact Sarah Rimmington at (202)387-8030 or (Cell) (202)422-2687

“Big Pharma is today salivating at the prospect of hijacking the healthcare reform process to enhance its ability to price gouge the American public.

As the House Energy and Commerce Committee meets to mark up healthcare legislation, it is expected to consider an amendment from Representatives Eshoo and Barton to authorize generic competition for biotech drugs. Currently, there is no regulatory process for approval of generic versions of this class of pharmaceuticals, known as “biologics.” Biologics make up roughly half of the most important new medicines, including many or most cancer drugs.Unfortunately, rather than creating robust price-lowering competition, the Eshoo/Barton approach would establish extended monopoly protections — exceeding the monopolies already conferred by patents — and a series of needless bureaucratic hurdles for approval of generics.

President Obama has signalled that in a spirit of “generous compromise” the pharmaceutical industry should be given seven years of monopoly protection for clinical test data — effectively prohibiting generics from entering the market for seven years after a drug goes on the market. The Eshoo/Barton proposal would establish a monopoly period of 14.5 years, and possibly longer. The Federal Trade Commission has concluded that no extra monopoly period is needed to promote innovation or ensure a fair return to brand-name biotech or drug companies.

President Obama’s healthcare reform effort has two goals: to expand coverage for the uninsured, and to control healthcare costs. The Eshoo/Barton proposal would torpedo the objective of healthcare cost containment. The bottom line is simply this: If the Eshoo/Barton approach is adopted, consumers and the government will pay many tens of billions of dollars more in drug costs than needed. Such a windfall for a Big Pharma is something that neither consumers nor the government can afford.”

Essential Action is a public health and corporate accountability group. Our Access to Medicines Project has worked on U.S. and global access to medicines issues for more than a decade. The project focuses on patent and related barriers to generic competition.