The July 20, 2009 issue of BioCentury has an extensive report on the “Biosimilar fire Drill.” It discusses in detail the lobbying by the Biotechnology Industry Association (BIO, bio.org) to defeat efforts by President Obama, OMB, the FTC, Representative Waxman, Senator Brown, AARP, Public Citizen, PIRG, Consumers Union, KEI, Essential Action, and others, to reform the regulation to biologic medicines, so there is more generic competition. (For an earlier discussions of the bill, go here or here).
What is unusual and surprising is the key role of Howard Dean to back an anti-consumer BIO backed measure in the health reform bill.
“Biosimilar fire drill,” Steve Usdin, BioCentury, July 20, 2009.
… In bending political opinion about biosimilars, BIO benefited from the services of prominent Democrats, most notably former Democratic National Committee chair and former Vermont Gov. Howard Dean, and perennial Democratic presidential campaign manager Joe Trippi, as well as well-placed lobbying firms.
Dean, who represents the progressive, or more liberal, wing of the Democratic Party, surprised many on the political left by writing a commentary on biosimilars that was published in the July 8 issue of The Hill, a newspaper that is widely read on “Big drug companies Capitol Hill.
Dean repeated BIO’s talking points on biosimilars, contending that a “commonsense and fair approach, similar to the process and timeline currently in place for generic versions of chemical-based medicines, would allow the original developer of the biologic to protect the proprietary data used to develop the medicine for at least 12 years.”
Dean, who attacked pharmaceutical company profits during his 2004 presidential campaign, wrote in the commentary that a “shorter exclusivity period would prematurely rob biotech innovators of their intellectual property and destroy incentives to develop new cures.”
The Hill identified Dean as a physician, “former Vermont governor, Democratic National Committee chairman and presidential candidate,” but did not mention any relationship with BIO.
Meanwhile, Trippi weighed in with a July commentary on the Huffington Post website, the Democrats’ version of the conservative Drudge Report.
Trippi, who was Dean’s presidential campaign manager, wrote that “I hope members of Congress will take the approach Howard Dean advocates. Howard believes that biotechnology innovators need at least 12 years to make treatments affordable and accessible and make sure the drive for better treatments and new cures continues.”
Trippi said he had contacted his members of Congress to endorse 12 years of exclusivity for pioneer biologics, and urged his readers to do the same.
Trippi’s posting prompted a July 16 response on Huffington Post from Jamie Love, director of Knowledge Ecology International, a non-profit organization that advocates the reduction or elimination of IP protections for pharmaceuticals. Love called a House proposal for 12 years of exclusivity for all biologics “evil,” and noted Dean’s and Trippi’s advocacy of BIO’s positions.
Trippi subsequently announced on his blog that biotech represents “the only chance we have for a cure” to many diseases, including the Type I diabetes he suffers from. “ That’s why I passionately support biotech and those who are working everyday for better treatments and cures and why I work on behalf of the Biotechnology Industry Organization,” he wrote.
Trippi and Dean are not registered as lobbyists. Their activity, which supplemented the efforts of BIO’s in-house and external lobbyists, may not have met the legal criteria for requiring registration, but it was aimed at influencing the views and votes of members of Congress.
BIO reported $1.9 million in lobbying expenditures in the first quarter of 2009. Lobbyists who reported working specifically on biosimilars include two with deep ties to influential Democrats: Charles Brain of Capitol Hill Strategies LLC, who served as director of White House legislative affairs for President Clinton, and Paul Kim, a partner at Foley Hoag LLP who worked for Sen. Kennedy as deputy staff director for health policy and as counsel to Rep. Henry Waxman (D-Calif.).
In his e-mail to board members, (BIO President & CEO) Greenwood did not fail to include Dean in his praise. “Our team at BIO, the D.C. offices of our members, our consultants (now including former Vermont Governor and Democratic National Committee Chairman Howard Dean) did a magnificent job,” he wrote.
Dean signed on as “an independent consultant exclusive to the government affairs practice at McKenna Long & Aldridge LLP” in March 2009, according to the law firm. BIO’s Joseph told BioCentury McKenna has a contract to provide “general strategic consulting, messaging advice, and communications strategy” for the trade association.
Dean told BioCentury last week that he provides “long-term and short-term strategic advice to BIO. I do not lobby.” He became involved in the biosimilars campaign because “what happened last week was a crisis for the biotech industry.” Dean declined to discuss specific activities he undertook on biosimilars. According to Greenwood, Dean’s activities included “talking to some members [of Congress] about biosimilars.”
BIO’s top advocacy issue is ensuring that an FDA biosimilars approval process protects biotech innovation, Greenwood told BioCentury. “This issue has been my number one priority since I arrived here three and a half years ago,” he said. “This will form the statutory basis on which the whole enterprise of investing in and developing biologics will be based.”
“Governor Dean was very helpful to us” as BIO scrambled to respond to the Kennedy amendment, he told BioCentury. “As a physician clearly focused on healthcare, a Democrat leader and clearly to left of center, his efforts were impactful.”
“Dean has been a great addition to our team,” Stephen Sherwin, chair of BIO’s executive committee and health section, told BioCentury.