http://www.boston.com/news/health/articles... "...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.
After the Globe inquired about those ties, both Dean and Trippi said they only advocate for causes they genuinely support, but
said they should have disclosed those relationships and would do so in the future.Trippi, who suffers from serious complications of diabetes, noted that he has advocated for biotech for years.
But 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..."Howard Dean to Join McKenna Long and Aldridge LLP
Date:3/3/2009http://www.bio-medicine.org/medicine-news-... /
Obama administration had recommended a compromise of 7 years...
http://blog.pharmtech.com/2009/06/26/the-s... /
"...As discussed in PharmTech’s blog, the debate on data exclusivity for biologics was intensified with the release of a Federal Trade Commission (FTC) report earlier this month that said that the 12–14 years of regulatory exclusivity for biologics was too long to promote innovation particularly since innovator-drug firms would likely retain substantial market share after the entry of a follow-on biologic (FOB), according to an FTC press release.
GPhA agreed. “In citing the recent FTC report on biogenerics, the President rejects attempts by the pharmaceutical and biotech industries to needlessly extend market exclusivity provisions to an unprecedented period of 12 to 14 years simply to maintain their monopolies on biopharmaceutical products,” said GPhA President and CEO Kathleen Jaeger, in prepared statement. “The White House and Office of Management and Budget correctly recognize that this exclusivity model will not achieve what should be our shared goal of balancing pharmaceutical innovation and much needed consumer access.”
However, BIO, which represents innovator biotechnology drug companies, said curtailing exclusivity was ill-advised..."
Senate HELP amendment on "data exclusivity"
http://www.pnhp.org/news/2009/july/senate_... "Sen. Orin Hatch: I don’t know a biotech company that isn’t for this bill, for this 12 year data exclusivity.
.....
Sen. Tom Harkin: Keep in mind what we’re talking about here. We’re not talking about patents. Everybody gets a 20 year patent… What we’re talking about here is data, data exclusivity… How do you get that data? You get it through FDA supervised trials… Where do they do those clinical trials? Academic health centers. Who supports academic health centers? Our taxpayers… When should that data be released so that another company out there, some other entrepreneurs, can look at the data and say… I’ll bet if we changed this and did this, we might come up with a new formulation that might actually help something else. They’re still going to have to go through their clinical trials… At least they’ll be able to look at the data. If you don’t do that that means that the company can sit on that data for 12 years. Then they let the data out. Clinical trials will take another 7 years or more, so you’re going to have at least a whole 20 year run in there… before anyone can ever surface with anything even comparable to what that drug or that biologic is..."
