Shuler controversy health care

Bill Theobald, Gannett

Rep. Heath Shuler inserted a statement into the Congressional Record during the House health care reform debate that parroted language provided by lobbyists for a large biotechnology company, his office acknowledged Wednesday.

The statement supported language in the House bill that would give biotechnology firms 12 years of exclusive rights to new biologic drugs they develop and would promote developing generic versions of the treatments. Biologic drugs are complex medicines made using living organisms.

The New York Times reported Sunday that it had obtained e-mails showing that lobbyists for Genentech, a subsidiary of Swiss drug company Roche, had persuaded more than three dozen House members - Republicans and Democrats - to insert similar statements into the Congressional Record based on talking points the lobbyists provided.

Doug Abrahms, spokesman for Shuler, said the Waynesville Democrat "received and relied on" the statement provided by Genentech lobbyists. He said Shuler has long supported the biotechnology industry, which has a strong presence in North Carolina.

Abrahms declined to comment on whether it's proper to use language provided by an advocate. Some critics said using statements provided by lobbyists exemplifies the too-cozy relationship between corporate interests and members of Congress.

"North Carolina has been a leader in the development and production of many life-saving medical treatments, and more than 500 biotech companies have headquarters or operations in our state," Abrahms said in a written statement. "The purpose of Heath's remarks was to ensure that as we establish a pathway for the development and creation of (generic) biologics that we don't ship our intellectual property and North Carolina jobs to Asia."

At issue is how to regulate creation of generic versions of biologic drugs, which treat serious, life-threatening illnesses such as cancer, multiple sclerosis, diabetes and AIDS.

The biotech industry has argued for a longer term of exclusivity to offset the time and extra expense of developing biologic treatments. Generic firms and patient advocates argue that a shorter period of exclusivity allows for faster development of cheaper versions.

Shuler signed on as an early co-sponsor of a proposal authored by Rep. Anna Eshoo, D-Calif., and Rep. Joe Barton, R-Texas, that would grant 12 years of patent protection for biologics. A competing bill would have set a five-year term of exclusivity. The Eshoo-Barton language was inserted in the House health care reform bill.

Shuler, who voted against the House health care reform bill, did not speak during House debate on the bill on Nov. 7, but did insert the written statement in the Congressional Record, a common practice. Many entries in the Congressional Record praise the accomplishments of people from a member's district.

In the statement, Shuler said he supported language in the health care reform bill that would "provide lower-cost options to consumers and my constituents without destroying a healthy and functioning biotech industry in this country."

Identical language is included in statements from several House members.

Shuler's statement also said it was important to make sure that creating "a pathway for new products does not destroy the ability or the incentives of innovator companies to develop breakthrough technologies," another phrase repeated in the other statements.

"The Eshoo/Barton language was one of the few areas of health care reform that both Republicans and Democrats agreed on. As a common-sense Democrat, the congressman felt it was important to highlight issues in the health care debate where consensus could be reached," Abrahms said.

Additional Facts
Rep. Shuler's Nov. 7 statement as it appears in the Congressional Record
Mr. SHULER. Mr. Speaker, as you know I am opposed to the bill we are considering today for many reasons that I have articulated previously. I am pleased, however, that the bill strikes the appropriate balance on the issue of follow on biologics. This bipartisan compromise language will provide lower cost options to consumers and my constituents without destroying a healthy and functioning bio-tech industry in this country. The Barton-Eshoo biosimilar amendment in the Energy and Commerce Committee was one of the few issues that was addressed on a truly bi-partisan basis and ought to serve as model on how things should get done in Congress.
I believe it is critical that the creation of a pathway for new products does not destroy the ability or the incentives of innovator companies to develop breakthrough technologies. We have a moral obligation to provide a safe and effective pathway of bringing competition that will benefit patients. I wish we could consider this as a stand-alone bill because it would pass with the kind of overwhelming bi-partisan support that Americans across the country wish to see.
However, these provisions are only the first step in a long path to the marketing of these new products. New research and clinical testing will have to occur and the FDA will write rules that will ensure this research is done safely and effectively. One of the reasons I have long supported the U.S. biotechnology industry is that it is a homegrown success story that has been an engine of job creation in this country and in my home state of North Carolina. Unfortunately, many of the largest companies that would seek to enter the biosimilar market have made their money by outsourcing their research to foreign countries that don't have the same safety and efficacy standards that we have in the United States. With this week's devastating news that unemployment has reached 10.2 percent it is critical that we preserve jobs in America. While the innovators have created jobs here, these generic companies have shipped them overseas, so they can turn around and sell cheap knockoffs of innovative American products.
As this new market launches in the U.S., we need to ensure that we foster innovative products in this country for the creation of jobs and research that will go into proving whether these products are interchangeable with the innovator's products. I don't know whether these companies can create such interchangeable products, but I am certain that the research and testing of whether or not they should occur in this country and not somewhere across the globe. Testing and research on these interchangeable biosimilars should be required to occur in this country to ensure that it is done properly and safely.