SUPPLEMENTARY INFORMATION:

I. Background

The timely review of the safety and effectiveness of new drugs and biologics is central to FDA's mission to protect and promote the public health. Before the enactment of PDUFA in 1992, FDA's drug review process was relatively slow and not very predictable compared to other countries. As a result of concerns expressed by industry, patients, and other stakeholders at the time, Congress enacted PDUFA, which provided the added funds through user fees that enabled FDA to hire additional reviewers and support staff and upgrade its information technology systems. In return for these additional resources, FDA agreed to certain review performance goals, such as completing reviews of NDAs and BLAs and taking regulatory actions on them in predictable timeframes. These changes revolutionized the drug approval process in the United States and enabled FDA to speed the application review process for new drugs and biologics without compromising the Agency's high standards for demonstration of safety, efficacy, and quality of new drugs and biologics prior to approval.

PDUFA provides FDA with a source of stable, consistent funding that has made possible our efforts to focus on ( printed page 40073) promoting innovative therapies and helping to bring to market critical products for patients. When PDUFA was originally authorized in 1992, it had a 5-year term. The PDUFA program has been reauthorized every 5 years, with the most recent reauthorization occurring in 2007 for FYs 2008-2012. As directed by Congress in preparing for reauthorization of PDUFA for a new 5-year period, FDA conducted negotiations with regulated industry and conducted regular consultations with public stakeholders, including patient advocates, consumer advocates, and health care professionals between July 2010 and May 2011. Following these discussions, related public meetings, and Agency requests for public comment, FDA transmitted proposed PDUFA V recommendations to Congress for FYs 2013-2017 on January 13, 2012. If enacted into law, FDA's proposed PDUFA V recommendations will include an FDA commitment to implement a new review program for NME NDAs and original BLAs to enhance review transparency and communication between FDA and applicants on these complex applications.

II. PDUFA V NME NDA and Original BLA Review Program

FDA's existing review performance goals for priority and standard applications, 6 and 10 months respectively, were established more than 15 years ago. Since that time, additional requirements in the drug review process and scientific advances in drug development have made those goals increasingly challenging to meet, particularly for more complex applications like NME NDAs and original BLAs that generally are discussed in an FDA advisory committee meeting. FDA further recognizes that increasing communication between the Agency and applicants during FDA's review has the potential to increase efficiency in the review process.

To promote greater transparency and improve communication between the FDA review team and the applicant, FDA has proposed a new review model for NME NDAs and original BLAs in PDUFA V. The Program provides opportunities for increased communication by building in mid-cycle communications and late-cycle meetings between FDA and applicants. To accommodate this increased interaction during regulatory review and to address the need for additional time to review these complex applications, FDA's review clock will begin after the 60-day administrative filing review period for applications reviewed under the Program. The Program will apply to all NME NDAs and original BLAs received from October 1, 2012, through September 30, 2017. The goal of the Program is to improve the efficiency and effectiveness of the first-cycle review process by increasing communication with sponsors before application submission to improve the quality and completeness of submissions, and by increasing communications during application review. This will provide sponsors with opportunities to clarify previous submissions and provide additional data and analyses that are readily available, potentially avoiding the need for an additional review cycle when FDA's concerns about an application can be promptly resolved, but without compromising FDA's traditional high standards for approval. An efficient and effective review process that allows for timely responses to FDA questions can help ensure timely patient access to safe, effective, and high quality new drugs and biologics. To understand the Program's effect on the review of these applications, interim and final assessments by an independent contractor are key components of the Program. The performance commitments state that the statement of work for this effort will be published for public comment before beginning the assessment (section II.B). Because the assessment needs to commence at the beginning of PDUFA V on October 1, 2012, if the program is reauthorized, FDA must publish the statement of work for public comment in advance of that reauthorization to be able to begin the assessment on October 1, 2012. Accordingly, FDA is seeking public comment now on the proposed statement of work for the assessment of the Program, available at http://www.fda.gov/​downloads/​ForIndustry/​UserFees/​PrescriptionDrugUserFee/​ucm304793.pdf.

III. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) either electronic or written comments regarding this document. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.