Biotech firms lobby for say on healthcare
$66m effort to protect drug-patent exclusivity
By Lisa Wangsness
The Boston Globe
July 21, 2009
The 46 million Americans without health insurance are probably not spending much time thinking about how Congress should curb monopolies on expensive biotech drugs. But the issue, which offers a case study in the ways of Washington influence, is among dozens that have spurred a lobbying frenzy this summer as Congress debates a historic healthcare overhaul.
Pharmaceutical interests alone, including many from Massachusetts, spent more than $66 million on lobbying in just the first quarter of this year, up 25 percent from last year, according to the nonpartisan Center for Responsive Politics.
Biotech firms produce the most expensive drugs on the market, charging $10,000 to $100,000 a year for a single patient, and generics would seriously undercut those prices. In their quest to win a 12-year exclusivity period for their drugs, free from such competition, biotech companies have launched a massive education campaign about what they say are the sky-high research and development costs involved with bringing them to market.
To help carry the message, they are paying well-connected lobbying firms, sponsoring radio ads as well as academic studies, and contributing to the campaign coffers of influential lawmakers.
“You get one crack at it,” said Robert Coughlin, president of the Massachusetts Biotechnology Council, speaking of the task of drawing up a licensing system for “biogenerics.” “If it isn’t done right, it could literally put the biotech industry out of business.”
The quest for influence is not always obvious.
Howard Dean, the former Democratic Party chairman, wrote an opinion piece this month in The Hill, an influential Capitol Hill newspaper, arguing that fewer than 12 years of monopoly rights for biotech companies’ products “would prematurely rob innovators of their intellectual property and . . . destroy incentives to develop new cures.”
Within hours Joe Trippi, a Democratic consultant who ran Dean’s 2004 presidential race, hyped Dean’s opinion piece in a blog post that he sent to The Huffington Post, a widely read website. “He’s a doctor and lifelong advocate for health reform - he knows what he’s talking about,” Trippi wrote, urging readers to contact their lawmakers.
Dean failed to note in his editorial that he is an adviser to McKenna, Long & Aldridge, a global law firm that is advising the Biotechnology Industry Organization, the influential trade group. Nor did Trippi mention that his public relations firm handles social media projects in a partnership with the Boston public relations company Brodeur Partners, which also has BIO as a client.
Dean said his editorial was part of McKenna’s rapid-fire response to an unexpected, eleventh-hour Senate health committee proposal (which biotech firms ultimately fought off).
“It was a huge scramble, all hands on deck,” Dean said.
The legions of lobbyists, strategists, and legal consultants involved include former senior aides to key lawmakers and executives. Top biotech companies are clients of Foley Hoag, a law firm with offices in Boston and Washington, which has deployed Nick Littlefield, former staff director and chief counsel for Senator Edward M. Kennedy’s health committee, and Paul Kim, the former deputy health counsel to the Kennedy’s committee.
Biotech won a major battle last week when Kennedy’s Senate health committee gave biotech firms the 12-year protections they wanted, plus six months for pediatric versions. The committee rejected a proposal by Senator Sherrod Brown, Democrat of Ohio, for a much shorter monopoly period. After the vote, generics companies said they wouldn’t even bother trying to make generic biologics because the 12-year protection would make the enterprise unprofitable.
“The pharmaceutical industry, especially the biotech industry has an awful lot of power in the halls of Congress,” Brown told reporters.
State leaders from around the country, including Governor Deval Patrick, wrote letters to their delegations supporting a biotech-friendly bill. CEOs have flown to Washington to drive their points home. The Globe reported earlier this year that Amgen donated $1 million to the Edward M. Kennedy Institute for the United States Senate at the University of Massachusetts Boston, a project being developed by people close to the senator but not Kennedy.
In the health committee vote last week, a number of other left-leaning Democratic senators sided with the industry, including Patty Murray of Washington, Barbara Mikulski of Maryland, Jack Reed and Sheldon Whitehouse of Rhode Island, and Kay Hagan of North Carolina. Kennedy supported the measure by proxy.
Hagan, a freshman senator whose state is home to a biotech sector, was assigned to the health committee this winter. Few were surprised when she cosponsored the industry-friendly amendment. But biotech firms were not taking chances: In the first half of this year, they poured $16,000 into her campaign account. Hagan believes the protections are necessary to support research for new drugs.
http://www.boston.com/news/health/articles/2009/07/21/biotech_firms_lobby_hard_for_say_on_healthcare/--------------
July 14 quote of the day on the 12-year data exclusivity amendment:
http://www.pnhp.org/news/2009/july/senate_help_amendmen.phpComment:
By Don McCanne, MD
The vote on the data exclusivity amendment was covered in a qotd last week, at the link above. More background information is provided by Lisa Wangsness in her Boston Globe article. Because of the implications for the reform process unfolding in Washington, we are taking a second look.
Having a twenty year patent on a biological that can command a one hundred thousand dollar price tag is not enough for the biotech firms. They also want a 12 year lead time before competitors can begin to use the data, produced in our academic medical centers, for developing new innovative drugs or even generic equivalents. This doesn’t change the 20 year patent exclusivity, but it requires future competitors to wait 12 years before beginning their research that would be based on the existing data.
That slows future innovation and research. It slows the introduction of generics that can result in competitive pricing. It decreases the chance of breakthroughs that could replace a one hundred thousand dollar biologic with a two hundred dollar product that might be more effective and less toxic.
Watching the prolonged committee deliberations on the 12 year data exclusivity amendment, it was obvious that the arguments presented by the senators in support of this amendment had been written by the biotech lobbyists. It was also obvious that only a few of the senators had rejected the lobbyists’ overtures.
The Boston Globe article demonstrates that this was not about policy, but about process. It shows how the most powerful lobbyists can cast their nets and pull in the best of them.
Howard Dean was a part of the “all hands on deck” scramble to support the data exclusivity amendment. It was simply a job that he was expected to do as part of the McKenna rapid-fire response team.
It was particularly painful to watch Senator Dodd, acting chairman of the Senate HELP Committee, cast an aye vote by proxy on behalf of Sen. Ted Kennedy, even though Sen. Dodd had already cast a no vote on his own behalf. It would be unfair to speculate what may have caused Sen. Kennedy to communicate his wishes on that vote, but it is likely that Amgen feels that they paid a million dollars for that vote, fair and square.
Does anyone else agree that we need a fully transparent re-start on reform?
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A link to Dr Dean's op-ed in The Hill is--
http://thehill.com/op-eds/legislation-on-innovative-drugs--is-key-to-health-reform-2009-07-08.html(flame retardant on)
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