Sign-on Letter for Amendment 2858 Ethical Pathway for Generic Pharmaceutical Products, 111th Congress

This sign-on letter has been closed

Senator Bernie Sanders (I-VT) has submitted the amendment 2858 to the health reform bill, to create an Ethical Pathway for the registration of generic medicines.

For background on the substance and rationale, I have a short blog describing the amendment here

Senator Sanders Amendment 2858 would replace data exclusivity with cost sharing, if new trials violate medical ethics

Senator Bernie Sanders (I-VT) has offered an amendment to the health care reform bill that would eliminate data exclusivity in cases where duplicating clinical trials involving human subjects would violate Article 20 of the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human subjects. The relevant article from the Declaration of Helsinki reads as follows:

Roll Call on Biogenerics

James K. Glassman and I published an article on biogenerics today in Roll Call.

The Protection of Pharmaceutical Test Data: A Policy Proposal, KEI Research Paper 2006:1

Cite as Judit Rius Sanjuan, James Love and Robert Weissman, Protection of Pharmaceutical Test Data: A Policy Proposal, KEI Research Paper 2006:1.


Judit Rius Sanjuan, James Love and Robert Weissman*2

KEI Research Paper 2006:1

21 November 2006

The Obama Administration support for a pro-consumer Biosimilars Pathway is:

10% (4 votes)
Hardly noticeable
90% (36 votes)
Total votes: 40

Howard Dean: “I’m actually not a shill for the bio industry”

The Center for American Progress hosted a video conference of Dr. Howard Dean talking about Health Care reform on Tueday. The video is on the web here. On this one hour program, Howard Dean spends a little over 3 minutes responding to allegations that he is a “shill” for BIO, on the issue of biosimilars.

Howard Dean as a shill for BIO, on Biosimilars bill

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, 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.

Anna Eshoo Biosimilars (HR1548) bill has bad provisions on data exclusivity

Congress should reject the 12-14.5 year monopoly for biologic products provided for in HR 1548

KEI* opposes H.R.1548, the bill to “establish a pathway for the licensure of biosimilar biological products,” on the grounds that the period of the monopoly is excessive, and not subject to safeguards that would protect consumers.

KEI 2007 Special 301 Submission to USTR on Pharmaceutical Test Data Protection

KEI “Special 301” Submission to USTR on Pharmaceutical Test Data Protection

12 February 2007

Knowledge Ecology International (KEI) is a non-governmental organization that searches for better outcomes, including new solutions, to the management of knowledge resources.

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