Under a 2007 law, the companies that FDA has been negotiating with, led by Johnson & Johnson and Medtronic Inc., were charged $295 million over five years to get their products reviewed in a timely manner. The law, set to be reauthorized this year, mandates that the agency submit a new agreement to U.S. lawmakers by January 15.

FDA has now missed the mark, and may not arrive at an agreement by February 15, when a U.S. House hearing is set on the law. The agency is now seeking as much as $805 million over five years to add staff, responding to industry and congressional criticism that its approval system is too slow. According to the latest minutes available, the industry has agreed to pay only $447 million. 

The deadline of January 15, is the second that the agency has missed. Earlier, Senators Thomas Harkin (D-Iowa), and Michael Enzi (R-WY), has asked FDA to submit a re-authorization plan by December 31. 

It’s expected that FDA and the industry may reach an agreement by February 15 to avoid Congress taking over negotiations.

The industry has complained that regulators increasingly make last-minute requests for more information, slowing review times, even with the fee system. In 2010, FDA took an average of 73 days on average to complete less-stringent reviews of devices that pose a low-to-moderate risk to patients, down from 80 days before companies paid fees in 2001, according to a Bloomberg Government study. More than 90 percent of devices are reviewed under the less-stringent process, known as 510(k).

FDA has proposed a user fee increase between $730 million and $805 million over five years depending on how often companies seek consultations with regulators, stating that the agency needs between 225 and 321 employees to do reviews. 

The $447 million offer from the industry would account for about 26 percent of the agency’s medical-device review budget by fiscal 2017, the final year of the proposed pact. While manufacturers paid $35.2 million in fees in fiscal 2007, or about 13.2 percent of the agency budget for reviews, the agency argues that drug makers fund about 60 percent of the cost of agency reviews.