Today, the House Appropriations Agriculture Subcommittee met to consider the fiscal year 2011 bill that funds the Food and Drug Administration (FDA). The Subcommittee approved $2.571 billion in funding for the FDA.
This is an increase of $214 million above last year’s level and $55 million above the President’s request. C3 is very pleased with this proposed increase, and applauds the leadership of Chairwoman De Lauro, Ranking Member Kingston and the members of the Subcommittee.
Earlier this month, C3 advocates went to Capitol Hill to urge Congress to increase funding for the FDA. Register today as a C3 advocate, and we will update you on what you can do to help us make sure this increased funding for the FDA stays in the bill as it moves through the appropriations process.
Chairwoman DeLauro released the following statement following subcommittee approval of the bill highlighting the importance of FDA funding while also emphasizing some areas of Congressional concern with the agency:
“The Food and Drug Administration is always one of the most important agencies under our purview, particularly given that more than 20 cents of every dollar spent by American consumers is on an FDA-regulated product…I believe there is strong leadership at the FDA under Commissioner Hamburg. But I remain concerned about the existing structure at the agency, especially as it pertains to drug safety.
So we have included targeted resources to help make a difference in this area, including an additional $65 million for staff to review generic drug applications, drug company ads targeted at consumers, and, for the first time to my knowledge, an increase specifically for review of drug company ads to doctors. We are also funding more safety reviews for drugs already on the market, more inspections of foreign drug facilities, and providing more funds to safeguard clinical trials and improve the oversight of imported foods. For example, the bill includes:
- A $15 million increase over the request for the office of generic drugs
- A $3 million increase for the review of direct consumer ads
- A $2 million for the review of communications to medical professionals in the Division of Drug Marketing and Communication
- A $7 million increase over the request for the Center for Devices and Radiological Health
- A $16 million increase over the request for the center and field activities in the Center for Food Safety and Applied nutrition related to imported food safety.
In addition, we have included report language that we worked on with Sen. Grassley and Congressman Hinchey that outlines the need to create an independent office on post-market drug evaluation. Thank you Congressman Hinchey for your leadership on this issue. As we learned from the hearing the subcommittee held about the Avandia case, there may be an inherent bias when those that approve drugs continue to play a role in determining their safety in a post-market environment.
We have also included report language that we worked on with Congresswoman Emerson that directs FDA to provide a report on the status of developing standards for a track and trace system for prescription drugs, one that would document all parties involved in the prior sale, purchase, and trade of a given prescription drug beginning with the manufacturer. This is critical to improving the security of the drug supply chain from counterfeit or other substandard products and to protecting consumers. Thank you Congresswoman Emerson for your work and leadership on this.”