August 7, 2006
The Honorable Edward Markey
Member of Congress
Washington, DC 20515
Dear Congressman Markey:
Congratulations on your introduction of HR 5922, the “Swift Approval, Fair Evaluation (SAFE) Drug Act.”
For the past several years, Consumers Union, the independent, non-profit publisher of Consumer Reports, has been conducting a national campaign to strengthen the Food & Drug Administration’s drug safety laws. We believe your proposal provides a comprehensive solution to the many drug safety enforcement problems that have been plaguing the FDA. Through the use of an effective set of Civil Monetary Penalties and other enforcement tools, your bill guarantees that drug manufacturers would—in fact—undertake reasonable and necessary drug safety research, without delaying the approval of new, life-saving drugs.
Your bill also greatly strengthens ‘whistleblower’ protections within the FDA. The recent report by the Union of Concerned Scientists on their poll of 1000 FDA scientists and physicians clearly shows that scientific integrity and morale within the agency needs to be strengthened and a climate of honest, public debate developed. Certainly, protection for those who question the prevailing viewpoint on scientific grounds is the first step in building a new culture of trust.
Thank you again for your long and continuing leadership on these and other key consumer safety issues.
Senior Policy Analyst (Health)