Obama signs FDA user fee renewal bill
July 10, 2012
by Brendon Nafziger, DOTmed News Associate Editor
The Food and Drug Administration user fee renewal bill is now the law of the land.
On Monday, President Barack Obama signed into law S.3187, or the FDA Safety and Innovation Act, which reauthorizes the FDA's powers to collect some $6.4 billion in user fees from medical device manufacturers and pharmaceutical companies to help offset the costs of application reviews and inspections.
The new law, which enjoyed hearty bipartisan support and sailed through both houses of Congress, increases the amount of money FDA can raise from companies and, for the first time, also applies to generic drug and biologics manufacturers.
The legislation also includes some tweaks pushed for by device companies. For instance, the FDA must measure the time it spends reaching a decision on a device submission by the total time used, rather than in "FDA days."
Significantly, too, it requires the FDA to release unique device identifier rules -- a new system for tracking medical devices in the supply chain -- by the end of the year. This point, however, is moot: the FDA released the rules, presumably not coincidentally, last week.
On Monday, President Barack Obama signed into law S.3187, or the FDA Safety and Innovation Act, which reauthorizes the FDA's powers to collect some $6.4 billion in user fees from medical device manufacturers and pharmaceutical companies to help offset the costs of application reviews and inspections.
The new law, which enjoyed hearty bipartisan support and sailed through both houses of Congress, increases the amount of money FDA can raise from companies and, for the first time, also applies to generic drug and biologics manufacturers.
The legislation also includes some tweaks pushed for by device companies. For instance, the FDA must measure the time it spends reaching a decision on a device submission by the total time used, rather than in "FDA days."
Significantly, too, it requires the FDA to release unique device identifier rules -- a new system for tracking medical devices in the supply chain -- by the end of the year. This point, however, is moot: the FDA released the rules, presumably not coincidentally, last week.