FDA to Receive More Money from Drug Manufacturers, But Denies Undue Influence

The proposed budget of the US Food and Drug Administration (FDA) is worrying many people. They are concerned that FDA’s annual increases in industry user fees—$828 million from manufacturers of medical and food products, including hundreds of millions drug manufacturers pay annually to help speed the review of new medicines—might compromise the agency’s independence. For fiscal year 2010, FDA is requesting a budget of $3.2 billion. The acting head of the U.S. Food and Drug Administration, Joshua Sharfstein, defended the agency’s request for more funding from drug companies: “I understand the concern that people . . . have expressed that user fees create a perception or a conflict of the agency’s work. I think these concerns reflect a broader lack of trust in the FDA.” To alleviate unease, he said, the new FDA head, Dr. Margaret Hamburg, must “renew the public’s confidence by acting with integrity and transparency” and send “the signal inside and outside the agency that we will make decisions based on the best available scientific evidence and not on influence that’s inappropriate.” The budget plan also seeks new fees to help clear a backlog of generic drug applications, and to reinspect food and medical product plants that fail to meet FDA standards. US Rep. Maurice Hinchey said the growing percentage of fees from drugmakers “is something of great concern for a number of people on our committee.” We agree. We believe it is time to reform the Food and Drug Administration from the ground up. If you have not done so already, please go to ReformFDA.org and sign this petition, which will be delivered to Congress.