House passes FDA’s $6.4 billion fee plan for drug reviews
The $6.4 billion accord that Teva Pharmaceutical Industries Inc. (TEVA), Johnson & Johnson (JNJ) (JNJ) and other companies reached with U.S. regulators to fund new medicine and device reviews through 2017 passed the House of Representatives.
The House voted late yesterday 387-5 in favor of the legislation, which is similar to a measure approved by the Senate May 24. Lawmakers must reconcile differences in the bills, such as dates for the Food and Drug Administration to comply with certain provisions and language in the Senate’s version that would require more scrutiny for some new devices.
The legislation would raise the so-called user fees industries pay the FDA for safety and efficacy reviews by more than $2 billion from the previous five-year period. Drugmakers in September and device companies in February agreed to the increases in exchange for more meetings with the FDA throughout the review process that may produce faster product approvals.
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