FDA and medical device makers reach user fee deal
http://news.yahoo.com/fda-medical-devic ... 44024.html
Associated Press – 5 hrs ago
WASHINGTON (AP) — The Food and Drug Administration has agreed to work toward more predictable, transparent reviews of new medical implants in return for a 100 percent increase in user fees from manufacturers, under a preliminary agreement.
The pact with the medical device industry announced Wednesday is expected to provide $595 million in user fees to the FDA over five years, allowing the agency to hire 200 new scientists. That amount essentially doubles the $295 million industry paid over the last five years of the arrangement. While not final, the agreement assures the continuation of a decadelong program in which the FDA supplements its budget with company payments. The latest agreement would require the FDA to provide more preliminary meetings with companies before device applications are submitted.
The announcement comes after more than a year of closed-door meetings between industry and the FDA which dragged on past the agency's self-imposed deadline for an agreement by Jan. 15. Medical device makers have made shorter, more predictable review times a key goal in this round of user fee talks, complaining that regulators in Europe and other foreign countries often approve devices faster than the FDA.
The FDA said in a statement it would send the final details of the agreement to Congress once they are completed. Congress must draft the agreement into law and approve it before Oct. 1 this year.