Sunday, January 14, 2007
Article in the Wall Street Journal -- FDA Change May Begin With User Fees, by Anna Wilde Mathews:
The Food and Drug Administration's deal with the pharmaceutical industry about user fees that companies pay the agency to review their products will likely prove a starting point for broader FDA-reform efforts backed by congressional Democrats.
The pact, unveiled yesterday, allows for substantially increased payments to the FDA, with more money allotted for monitoring the safety of medicines after they go on the market and a new fee for agency reviews of consumer television ads. Most of the money for the FDA's drug-review process comes from such fees.
Congress must approve the five-year deal before it can take effect, and while the drug industry will press for a user-fee bill without major additions, lawmakers are likely to consider far bigger changes that could result in new authority and responsibilities for the FDA. The confluence of must-pass FDA legislation including the user-fee reauthorization, and the takeover of Congress by Democrats, who are more inclined to take a tough stand against the drug industry, means major adjustments to the FDA have a better shot at passing this year than anytime in at least a decade.