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 /node/707.
If adapted, the amendment would eliminate test data exclusivity in favor of cost sharing, when a clinical trial would otherwise have violated Article 20 of the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human subjects.
Under current data exclusivity regimes, a generic drug company is asked to replicate clinical trials to prove a drug is safe and effective, even when there is no scientific benefit of the experiment. The amendment would eliminate this requirement, essentially eliminating data exclusivity.
The amendment would not change the status of products protected by patents, and it would require cost sharing if a generic company relied upon the innovators clinical trial data, during the period of data protection.
We would like to present Senator Sanders with a letter that endorses this amendment.
Please let me know if you or your group can endorse this letter:
Thank you for submitting amendment 2858, to create an ethical pathway for the registration of generic medicines. We strong support this amendment, because it would ensure that U.S. regulatory requirements for registering generic medicines do not include requirements for clinical trials that violate the ethical standards set out in Article 20 of the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human subjects. As you know, the United States government and all other members of the World Health Organization (WHO) have agreed that drug registration requirements should be consistent with the ethical standards set out in the Declaration of Helsinki. Your amendment will ensure that patients are protected by these ethical standards, while providing for a system of cost sharing for drug registration data that will protect the legitimate interests of the innovators.
Sincerely,
To sign this send a note to ethicalpathway@keionline.org, with the following information
Name:
Title/Affiliation
City and State of residence or workplace
Contact details (email address and telephone)
(optional) Any comment that we could use in a background document for the press