Senate HELP amendment on "data exclusivity"
NVCA Study Supports 12-Year Data Exclusivity Period
By Donald Zuhn
Patent Docs
Biotech & Pharma Patent Law & News Blog
July 13, 2009
On Friday, the National Venture Capital Association (NVCA) released the results of a study suggesting that “a data exclusivity period of at least 12 years for innovator products is a critical fulcrum in the effort to balance cost with the preservation of biotech innovation.”
And…
Executive Session on the Affordable Health Choices Act
U.S. Senate HELP Committee
July 13, 2009
Consideration of the Enzi/Hatch/Hagan amendment on establishing a data exclusivity period of 12 years for biotech innovation
Sen. Orin Hatch: I don’t know a biotech company that isn’t for this bill, for this 12 year data exclusivity.
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Sen. Kay Hagan: These individuals are out there looking for venture capital to obviously help them get these drugs to market… In order for our country to maintain this innovation and this research we need 12 years of data exclusivity.
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Sen. Judd Gregg: Money flows into biologics research because capital moves there to make money. That’s the way a market system works.
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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.
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Sen. Bernie Sanders: Let’s find out why year after year the drug companies make hugh profits, look at why the drug companies have never once, to the best of my knowledge, have never lost a political debate here in Congress… (medicine) doesn’t do anybody any good if they can’t afford it. I think for year after year we’ve been paying a lot of attention to our friends in PhRMA, who are spending, I don’t know what they spend in lobbying and campaign contributions, a whole lot of money. Maybe it’s time that we start worrying about the people who have to pay for this medicine.
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Sen. Sherrod Brown: You know what we’ve not talked about, Mr. Chairman? We’re not talking about how much these biologics are costing patients. Let me give you some numbers. (examples)… 48 thousand dollars… 20 thousand dollars …100 thousand dollars. You know what the average wage in my state is? 46 thousand dollars… If we do this giveaway to the drug industry, this giveaway to the biologic companies, it means profits are up for them, it means executive salaries are up for them, it means we can all feel good, but let’s think about the patients, let’s think of the patient with breast cancer who has got to spend 1000 dollars a week… the patient with colon cancer who’s got to spend 2000 dollars a week… What kind of progress is that, Mr. Chairman?
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The data exclusivity amendment passed by a vote of 16 to 7, with several Democrats voting in support.
421 minute video of the July 13 afternoon session:
http://help.senate.gov/Hearings/2009_06_17_E/2009_06_17_E.html
Comment:
By Don McCanne, MD
For the past week or so I’ve been live-streaming the Executive Session of the Senate HELP Committee as they have been marking up the Kennedy health care reform bill, the Affordable Health Choices Act. It has been running at the corner of my computer screen while I have worked on other projects. Since I am not competent at multi-tasking, I’m pretty jaded right now.
Last evening’s session devoted to the data exclusivity amendment was the longest amount of time they spent on any issue in the reform legislation. I stopped my other work to watch it. This morning, I’m not only jaded, but I’m also depressed. I’ll tell you why.
Earlier in the day yesterday, I sent out the following quote from Bill Moyers: “Nothing will change — nothing — until the money lenders are tossed out of the temple, the ATM’s are wrested from the marble halls, and we tear down the sign they’ve placed on government — the one that reads, ‘For Sale.’”
I didn’t sleep last night. Instead of counting sheep, I kept watching, in my nightmare, each of those Senators who voted yes picking up their bundle from the ATM machine in the marble halls on their way out as they passed the “For Sale” sign at the door.
But this isn’t about my nightmare. It’s about the 307 million of us who are the merchandise in Congress’s rummage sale. That’s why I’m depressed.