Steve Usdin reports in BioCentury:
“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. 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.”
“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 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 cure.” 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.”
"In his e-mail to board members, 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 told BioCentury last week that he provides ‘long-term and short-term strategic advice to BIO. I do not lobby.’ ”
In the same article Usdin also reports:
“Speaking at a briefing last week at the Center for Medicine in the Public Interest, Rep. Anna Eshoo (D-Calif.) said she plans to introduce a version of her Pathway for Biosimilars Act (H.R. 1548) as an amendment during Energy and Commerce Committee markup of its draft healthcare reform legislation.
The Eshoo amendment, which hasn’t been publicly released, “embodies the strengths of both H.R. 1548, as well as the recently passed Hatch/Enzi/Hagan Amendment at the HELP Senate Committee,” Greenwood noted in a July 16 letter of support for the Eshoo amendment.”
“The Eshoo amendment combines the 12-year exclusivity provisions passed by HELP last week “while also retaining the important provisions in H.R. 1548 aimed at avoiding patient and provider confusion over biosimilar products and ensuring patent disputes will be resolved prior to the expiry of data exclusivity.’ “
“Greenwood’s letter stated. H.R. 1548 requires that all biosimilars be assigned a unique international non-proprietary name (INN) rather than adopt the INN for the reference product as is the case for generic drugs. BIO has advocated for unique INNs, while biosimilars manufacturers oppose this as a barrier to interchangeability. Eshoo seems to have lined up enough support in the Energy and Commerce Committee to get the amendment passed — 23 of its 59 members are co-sponsors — if a vote is taken.”
CMPI (the public policy home of drugwonks.com) was proud to have sponsored that event (which also included comments by Representative Mike Rogers (R, MI), the Honorable Mike Ferguson, Former Vice-Chairman of the House Health Subcommittee (and a CMPI senior fellow), John F. Crowley, CEO, Amicus Therapeutics, Founder, CrowleyFamily5.com, and Dr. Geno Merli, Senior Vice President & Chief Medical Officer, Thomas Jefferson University, and Director, Jefferson Center for Vascular Diseases.
Video of this event will be available shortly on www.cmpi.org
