The Food and Drug Administration Safety and Innovation Act, more commonly known as FDASIA, was signed into law on July 9, 2012 (Public Law 112-144) and has been getting increased publicity as the provisions in the Act are getting more action and traction.  In passing FDASIA, FDA was granted important new authorities to: collect user fees for generic drugs and biosimilars; were reauthorized to collect human drug and medical device user fees  by Congress; and to administer two programs that encourage pediatric drug development.  The user fees are intended to help fund FDA’s review process for branded/generic drugs, medical devices and biosimilars, and to increase the transparency of the Agency’s review process.  Through the period covering FDASIA, the new law places 150 specific requirements on FDA, including the promulgation of 19 regulations, 24 guidances, and 14 reports to Congress.

The eleven (11) titles under FDASIA are provided below. The first five (5) titles reauthorizes or puts in place User Fee Acts until FY 2017.

Title I:   Prescription Drug User Fee Amendments of 2012

Title II:   Medical Device User Fee Amendments of 2012

Title lll:   Generic Drug User Fee Amendments of 2012

Title IV:  Biosimilar User Fee Act of 2012

Title V: Pediatric Drugs And Devices

Title VI:  Medical Device Regulatory Improvements

Title VII:  Drug Supply Chain

Title VIII: Generating Antibiotic Incentives Now

Title IX:      Drug Approval And Patient Access

Title X: Drug Shortages

Title XI: Other Provisions

When Congress passes legislation that affects the FDA, they typically change the Agency with new responsibilities, but usually do not provide the funds for the FDA to implement its new required activities.  In today’s budget conscious environment (and with the additional burden of sequestration), the FDA, like other government agencies, is being asked to do more with less. 

A description of each of the titles including significant changes and FDA’s performance goals will be provided in a series of installments in the Lachman Blog, starting with the Prescription Drug User Fee Amendments (PDUFA) of 2012 below.


Prescription Drug User Fee Amendments of 2012


FDASIA reauthorized the PDUFA for the fifth time since 1992 and the user fee program is known as PDUFA V; in effect from October 1, 2012 through September 30, 2017.  FDA has also issued PDUFA V Reauthorization Performance Goals and Procedures for FYs 2013 – 2017 (PDUFA V Performance Goals) that commits the agency to timelines on various NDA and BLA review issues and the interaction between drug sponsors and the agency during the review process. One performance goal is the implementation of a new review program for new drug applications (NDAs) for new molecular entity (NME) and original biologic license applications (BLAs).  The purpose of the program (“Program for Enhanced Review Transparency and Communication for NME NDAs and Original BLAs”) is to provide more first cycle approvals through the development of a process to facilitate the resolution of review issues in a timely manner.  The program applies to all NME NDAs and original BLAs received from October 1, 2013 through September 30, 2017 and also include those applications that are resubmitted following a refuse-to-file (RTF) action.  Under PDUFA V, FDA will review and act on 90% of standard NME NDA and original BLA applications within 10 months of the 60-day filing date and 90% of priority NME NDA and original BLA submissions within 6 months of the 60-day filing date.

The program incorporates new review elements such as pre-submission meeting, mid-cycle communication, late-cycle meeting. The pre-submission meeting is strongly encouraged by the Agency and, at this meeting, FDA and the drug sponsor will agree on the content of the application for the proposed indication, including preliminary discussion on the need for a risk evaluation and mitigation strategies (REMS) or other risk management actions. The mid-cycle communication provides the applicant a status of the review and any significant issues noted by the submission reviewers. The late-cycle meeting is intended to provide the application a status of the application late in the review cycle. Discussion items may include significant deficiencies, REMS or additional data or information that the applicant may be submitting.

FDA will handle major amendments differently under PDUFA V. Under the new law, FDA could extend the PDUFA date based on the submission of major amendments at any time during the review process.

FDA is committed to managing the application review proactively by use of a tracking system and will be documenting key milestones from the review team.

For further assistance on this or other compliance and/or regulatory matters please contact Arlene Ocampo, Ph.D., Senior Vice President, Compliance at and/or  Joan Janulis, Vice President, Regulatory at