Data
Test Data
Misc links:
How to Calculate Standard Patent Expiry Dates and Data Exclusivity in Key Territories
Internal links
Sign-on Letter for Ethical Pathway for Generic Pharmaceutical Products
Submitted by James Love on 5. December 2009 - 17:14Senator 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 http://keionline.org/node/707.
Senator Sanders Amendment 2858 would replace data exclusivity with cost sharing, if new trials violate medical ethics
Submitted by James Love on 4. December 2009 - 9:32Senator 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
Submitted by James Love on 9. September 2009 - 14:19James K. Glassman and I published an article on biogenerics today in Roll Call.
The Obama Administration support for a pro-consumer Biosimilars Pathway is:
Submitted by James Love on 22. August 2009 - 0:05Significant
10% (4 votes)
Hardly noticeable
90% (36 votes)
Total votes: 40
Howard Dean: “I’m actually not a shill for the bio industry”
Submitted by James Love on 21. July 2009 - 22:00The 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
Submitted by James Love on 19. July 2009 - 22:00The 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, bio.org) 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
Submitted by James Love on 16. July 2009 - 12:00Congress 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
Submitted by James Love on 12. February 2007 - 17:44KEI “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.
