Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Communication Strategies. Case Studies. Applied Knowledge.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory News | 11 July 2016 | By Zachary Brennan
Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), reported on Monday via email that as of 1 July 2016, CDER has acted on more than 90 percent of the Generic Drug User Fee Amendments (GDUFA) backlog, thereby accomplishing the agency’s backlog commitment more than one year ahead of schedule.
Under the $1.5 billion GDUFA, which allows generic drug companies to pay user fees to FDA for a more consistent timeline for generic approvals, FDA was required to review and take regulatory action on 90% of the backlog of abbreviated new drug applications (ANDAs) and prior approval supplements pending with FDA or industry as of 1 October 2012. GDUFA required FDA to meet this goal by 30 September 2017, which is the end of the five-year funding period authorized under GDUFA.
The confirmation of GDUFA’s success ahead of its deadline comes more than seven months after Woodcock had predicted the agency would accomplish the feat ahead of the next reauthorization of GDUFA, which is already underway. She also noted that as of January, 6,218 ANDAs have been addressed since GDUFA began, though about 10% haven’t entered review yet and 2,400 ANDAs are still pending as FDA is still discussions with those companies, while almost 600 have been withdrawn.
And although the total workload of ANDAs continues to rise, the number of ANDAs currently with FDA has declined by about 160 ANDAs over the past three months, according the agency’s second generic drug review dashboard released in May.
“Most applications from the backlog will need to come back to FDA for additional review before approval is possible, so we still have a lot of work ahead of us. But this is a significant milestone. We are exceeding our negotiated GDUFA commitments,” Woodcock wrote in an email to staff on Monday.
She also said meeting this goal “was a heavy lift” for FDA’s Office of Generic Drugs, Office of Pharmaceutical Quality and within CDER, the Office of Strategic Programs’ Office of Business Informatics, Office of Compliance, Office of Management, Office of Regulatory Policy, and Office of Translational Sciences’ (OTS) Office of Study Integrity and Surveillance.
“Outside of CDER, our partners in the Office of Regulatory Affairs (ORA) conducted timely inspections in close coordination with us. The Office of Chief Counsel addressed ANDA receipt and approval-related matters. And staff both within and outside of CDER pitched in, such as staff in the Office of New Drugs Toxicology group, who helped tackle the massive increase in controlled correspondence and consults; OTS’ Office of Clinical Pharmacology staff, who assisted with injectable reviews; and ORA, who assisted with dissolution reviews,” she wrote.
And despite FDA’s near-term success, industry groups are also highlighting areas where more work needs to be done for the next GDUFA.
The Generic Pharmaceutical Association said in comments on the previous GDUFA: “To date approximately $900 million has been invested into the program resulting in (1) decrease transparency, in particular meaningful communications, (2) decrease predictability for industry and (3) decrease access for patients…Although we commend FDA for exceeding the hiring metric of bringing on board more than 1,000 new hires to help ‘move the freight.’ Industry has experienced considerable and unforeseen ‘pain’ during the transitional phase of GDUFA.”
Tags: GDUFA, ANDA backlog, generic drug user fees