Senator Sanders Letter to FDA: U.S. needs an ethical pathway for biological products

On November 2, 2010, U.S. Senator Bernard Sanders (VT-I) sent a letter to Margaret Hamburg, the FDA Commissioner, urging the agency to review the ethical implications of the 12 years of marketing exclusivity created by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).

Today, during a 2-day public hearing organized by the FDA, Michael Behan from the office of Senator Sanders presented the letter, and discussed S. 3921, 111th Congress, the Ethical Pathway Act of 2010, which would ensure that rules for the approval of pharmaceutical and biological products do not require violations of medical ethics in the testing of products in humans and vertebrate animals.

The Sanders letter to the FDA is available here. A copy of S. 3921 and additional background information is available here.

In the same FDA hearing, KEI presented a statement based upon this written submission.