There has been no increase in congressional appropriations to the FDA from fiscal years 1986 through 2006. (1)
FDA’s Mission Statement
The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.
History of FDA
http://www.emedicinehealth.com/fda_overview/article_em.htm
How FDA conducts clinical trials to see whether drugs are safe and effective:
- Medical schools at public and private universities;
- The drug manufacturer seeking FDA approval;
- For-profit companies working for drug manufactures.
The cost of expensive clinical trails to demonstrate a new drug is safe and effective typically is paid by the drug manufacturer.
The user fee act, approved by Congress in 1992 , was reauthorized in 1997 and 2002 . Since its enactment, it has permitted the FDA to increase its staff to review new drugs from 1,277 in 1992 to 2,503 in 2004 .
Fees paid by the drug industry to the FDA to speed promising treatments to market have doubled from 1998 to 2005.
In fiscal 2004, drug companies paid $232 million in fees to the FDA, accounting for 53 percent of the agency’s $436 million budget for new-drug review. The 2007 budget includes $320.6 million in fees to be paid by drug makers.
The FDA is requesting additional funding from drug makers to support increased after-market safety. An estimated $100 million is needed to add needed drug safety personnel and other improvements.
Every 100 additional reviewers shortened the time it took the FDA to consider a new drug application by 3.4 months.(2)
In 2005, the median time for review and approval was six months for high-priority drugs.
Over the past ten years, the proportion of drug industry funding for the review of new drugs, has increased from 20 to 53 percent.
“For the FDA to be “perceived as independent” the funding it receives from drug companies should be limited.”
— Eli Lilly & Co. chief executive Sidney Taurel
Sources:
(1) Drug makers lobby US to hike FDA funds Firms say taxpayers should pay bigger part of bill for safety tests
The Boston Globe / Boston.com
(2) Harvard University government professor Daniel Carpenter.
