New User Device Fee Now Law

The President has signed the bipartisan Food and Drug Administration (FDA) bill that includes a medical device user fee of $609 million over the next five years.

The FDA has promised to hire more reviewers with the device money to speed up reviews of premarket application and 510(k) devices.

According to the Congressional Budget Office, the FDA would collect $4.1 billion in fees for review of brand-name prescription drugs, $1.6 billion for generic drugs, $609 million for medical devices and $128 million for less costly versions of biotechnology products.

Health and Human Services Secretary Kathleen Sebelius praised the bipartisan effort as Obama signed the legislation on July 9.

“[The Bill] is the culmination of the work of the administration and Congress, in partnership with patients, the pharmaceutical and medical device industries, the clinical community, and other stakeholders, to provide the Food and Drug Administration with the tools needed to continue to bring drugs and devices to market safely and quickly and promote innovation in the biomedical industry, and to help secure the jobs supported by drug and device development, ” she said in a statement.

The legislation sets performance goals for the agency, including deadlines that would reduce the time it takes for new products to reach the market. The goals were negotiated by the agency and drug and device companies.

The FDA took 73 days on average in 2010 to complete reviews of 510(k) devices, down from 80 days before companies paid fees in 2001, according to a Bloomberg study. .

Industry user fees, first enacted in 1992, give the FDA millions of dollars annually to review new products for the U.S. market but must be renewed every five years. The current version is set to expire in September.