On June 20, 2012, the U.S. House of Representatives passed by a voice vote a revised and purported final version of the Food and Drug Administration ("FDA") user fees bill. The House approved this legislation after three weeks of negotiations between certain House and Senate members to reconcile competing versions of the bill. The new version of the legislation was available Monday and approved by the House less than 48 hours later. The Senate is expected to vote on the House-approved bill sometime next week.
The House-approved version of the bill did not include controversial language that had existed in its prior versions. For instance, the revised version omitted an industry proposal to create a national system that would track drugs throughout the supply chain. In addition, the bill did not include a provision that would have prohibited brand name manufacturers from blocking generics companies from obtaining samples of their drugs by using certain FDA restrictions. Generics companies need these brand name samples for bioequivalence testing.
The House-approved bill, if enacted into law, will enable the FDA to collect billions in user fees from industry over the next five years and implement certain reforms. One provision requires the FDA to issue guidance within two years that describes the agency's policy on promoting drugs over the internet through the use of social meeting. Another provision instructs the FDA to accept clinical trial data from research trials performed in regulated foreign countries. The FDA would also gain increased authority to scrutinize the drug supply chain by requiring drug importers to register with the FDA. Drug manufacturers would also have to alert the FDA to potential shortages at least six months in advance.
For more information, click here and here. Megan Fanale Engel