A new guidance document published by the US Food and Drug Administration (FDA) establishes and otherwise clarifies the process by which biopharmaceutical and medical device companies need to pay user fees to the agency in return for the processing of their premarket approval (PMA) applications and device biologics license applications (BLAs).
In July 2012, President Barack Obama signed into law the FDA Safety and Innovation Act (FDASIA), which, among other things, authorized FDA to collect enhanced users fees for drugs and medical devices.
These fees are used to fund FDA's regulatory operations and, most notably, support review staff and fund regulatory improvements in technological infrastructure. The basic concept was established in the early 1990s in response to increasing delays in regulatory review times and growing backlogs of pharmaceutical applications. Medical devices received the same basic user fee structure in 2003 under the Medical Device User Fee and Modernization Act (MDUFMA), otherwise known as MDUFA I.
MDUFA is now on its third iteration under FDASIA, and companies can expect a few changes in MDUFAIII relative to MDUFA II, FDA explained in its guidance document.
New Fees, New Clarity for Applications
MDUFA covers an expansive amount of application types, everything from original and modular PMAs to supplements and minor changes like 30-day notices and periodic reports. BLAs are sometimes covered under the law as well, and are subject to the same fees as PMAs are.
The most obvious change: an increase in fees. For PMAs, sponsors will now need to pay $248,000 per application in FY2013. Panel track supplements will be allowed to pay less, with just $186,000 per application, and $37,200 for 180-day supplements. Periodic reports, which involve reporting of the least serious regulatory changes, are assessed an $8,680 fee per report.
As with prior iterations of the law, companies may be exempt from user fees if they are a small business submitting its first-ever PMA or BLA to FDA. Such a company would have less than $30 million in receipts for the year prior.
Companies must also meet a number of other considerations in order for an application to be accepted, FDA explained. For example, it must have been submitted with an electronic copy (eCopy) that meets required standards, and applications will be required to meet all other acceptance criteria as established in other recent guidance documents.
Certain fees may also be eligible for refunds if the application is not in working order. A deficient eCopy, for example, is eligible for a user fee refund, while a deficient 180-day supplement application is not eligible. However, for any application-even those eligible for refunds-requests to cancel an application and refund fees must come in advance of FDA taking action on the application. Otherwise, no refund will be forthcoming, FDA said.