NEWS RELEASE

Committee on Energy and Commerce
Rep. John D. Dingell, Chairman

Dingell, Stupak Again Question Whether FDA Knowingly Allowed Dangerous Drugs to be Sold to U.S. Consumers

Washington, D.C. – Reps. John D. Dingell (D-MI), the Chairman of the Committee on Energy and Commerce, and Bart Stupak (D-MI), the Chairman of the Oversight and Investigations Subcommittee, today announced another expansion of the Committee’s two-year inquiry into whether the Food and Drug Administration (FDA) has the capacity and leadership to protect Americans from unsafe prescription drugs. On the heals of the ongoing inquiry into the FDA regulatory failures in the Ranbaxy, Inc. case, the Committee today sent FDA the following letter, requesting documents relating to the August 2, 2008, recall of all drugs manufactured by Actavis Totowa LLC at the former Amide Pharmaceuticals plant in Little Falls, New Jersey.

The August 2nd recall followed on an earlier Class 1 Recall of digitalis, a heart drug that could have been fatal in the super-potent dosage that FDA asserts was negligently produced at that the New Jersey plant. The digitalis was recalled on May 8, 2008.

“Once again our Committee is forced to examine whether FDA can do its job to protect Americans from drugs produced in a manner that threaten the health and lives of American consumers,” said Dingell. “Apparently, companies such as Actiavis and Ranbaxy are allowed to operate and continue to receive approvals to manufacture other drugs long after FDA knew or should have known that their manufacturing operations were out of control and potentially lethal.”

“The Center for Drug Evaluation and Research (CDER) has ignored its mission to protect the public health,” said Stupak. “In case after case, we have seen FDA bend over backward to keep scofflaw companies in business and highly-questionable drugs on the market. A wholesale change in the decision-making apparatus at CDER is clearly needed if Americans are to trust the drugs prescribed by their doctors.”

For information on the Committee’s ongoing investigation into FDA drug safety, please visit: http://energycommerce.house.gov/Investigations/FDADrugSafety.shtml

Read the letter