FDA Accord with Drug makers Raises User Fees 6% to Renew Law

Drug manufacturers Pfizer Inc. and Eli Lilly & Co. have agreed with regulators on increasing 6% fees, as a part of their reauthorizing drug-approval process through financial year 2017. This accord has disclosed in parts on September 1st. The law will expire on Sept.30, 2012, so it must be approved before the given date.

The increased fees are likely to put in $40.4 million, revenue for the financial year 2012 and bringing the revenue toward $712.8 million by the year 2013.

The accord should permit more time to access for new safe and effective medicine. According to FDA, the agreement includes extra review time for the organization to fit in the extra meetings, by extending the for reviews after submitting applications to 8-months from 6-months, and 10-months to 12-months.

The FDA and the manufactures have agreed to set up the advisory panels and giving companies the time to collect the required data, in accordance to the agreement.

Agreement will also include a 3rd party review; weather FDA is meeting all the drug-evaluating goals, according to the agreement. In 2007, user fees were reauthorized; Congress gave FDA new responsibilities, which grounds the organization to slow its evaluating process.

The agreement will also help to bring back Food and Drug Administration's review performance.

New York-based Eli Lilly and Pfizer have been discussing with the Food and Drug Administration for a user-fee renewal process ever since July 2010. Medical-device Company New Brunswick based Johnson & Johnson is in different talks on fees that they pay the agency for product reviews. Device industry discarded the agency's proposal for paying more than double fees.