Jun 15, 2015 - manufacture of generic drugs and associated APIs. GDUFA Foundation: ... limits what FDA staff may share w
GDUFA Past & Present
David R. Gaugh, R.Ph. Senior Vice President for Sciences and Regulatory Affairs Generic Pharmaceutical Association June 15, 2015
About GPhA GPhA represents the manufacturers and distributors of finished generic pharmaceutical products, manufacturers and distributors of bulk active pharmaceutical chemicals, and suppliers of other goods and services to the generic pharmaceutical industry. Our members manufacture more than 90% of all generic pharmaceuticals dispensed in the U.S., and their products are used in more than three billion prescriptions every year. Generics represent greater than 86% of all prescriptions dispensed in the U.S.
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GPhA Members Regular Members 3M Drug Delivery Systems Actavis Inc. Alvogen Inc. Amneal Pharmaceuticals LLC ANI Pharmaceuticals Apotex Corporation Aurobindo Pharma USA Inc. BD Rx, Inc. Dr. Reddy’s Laboratories, Inc. Fresenius Kabi USA LLC G & W Laboratories, Inc. Glenmark Generics Inc., USA Heritage Pharmaceuticals Inc. Hospira Inc. Impax Laboratories, Inc. Kremers-Urban Pharmaceuticals Inc.
Lupin Pharmaceuticals Inc. Mallinckrodt Pharmaceuticals Momenta Pharmaceuticals Inc. Mylan N.V. Natco Pharma Limited Novel Laboratories-Gavis Pharma Par Pharmaceutical Companies, Inc. Perrigo PLC Sagent Pharmaceuticals, Inc. Sandoz Inc. Strides Pharma Inc. Sun Pharmaceutical Industries, Inc. Teva Pharmaceuticals USA Therapeutic Proteins International, LLC West-Ward Pharmaceuticals Wockhardt USA Inc. Zydus Pharmaceuticals USA
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FDA’s Mission “FDA is responsible for protecting the public health … FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable …” “The Office of Generic Drugs is responsible for providing regulatory oversight to expedite the availability of safe, effective, and high-quality generic drugs to patients. …We are committed to maintain the public’s confidence in an Agency that continues to meet the ever-changing needs of public health.” 4
Looking back: How we got to the landmark $1.5 GDUFA program? “We are at something of a tipping point … Looking ahead, it is clear that FDA will not be able to make ends meet with current resourcing, and more approvals will be delayed because of a lack of inspectional resources. That is why it is so important ... to constructively address the Generic Drug User Fee. No one benefits from a pending-
application queue of 2,000-plus products. Uncertainty and delays are costly to consumers, costly to industry—and hurtful to the public.” Margaret Hamburg, MD, FDA Commissioner GPhA Annual Meeting, Feb. 2011
FDA and industry jointly negotiated GDUFA which started on Oct. 1, 2012 as a five year program with industry paying annual inflation adjusted fees of $299 million through Sept. 30, 2017. “GDUFA focuses on quality, access, and transparency. QUALITY means ensuring that companies, foreign or domestic, that participate in the U.S. generic drug system are held to the same consistent high-quality standards and that their facilities are inspected biennially, using a risk-based approach, with foreign and domestic inspection frequency parity. ACCESS means expediting the availability of low-cost, high-quality generic drugs by bringing greater predictability and timeliness to the review of ANDAs, amendments, and supplements. TRANSPARENCY means improving FDA’s communications and feedback with industry to expedite product access and enhance FDA’s ability to protect Americans in our complex global supply environment.” 5 Janet Woodcock, MD, FDA CDER, House Subcommittee on Health Feb. 2012
GDUFA Foundation: 3 Key Aims of GDUFA Goals Safety – Ensure that industry participants are held to consistent high quality standards and inspected biennially, using a risk-based approach, with foreign and domestic parity Access – Expedite the availability of low-cost, high-quality generic drugs, increasing predictability and timeliness to approvals Transparency – Improve FDA’s communications and feedback with industry in order to expedite product access as well as enhance FDA’s ability to protect Americans in the complex global supply environment by requiring the identification of facilities involved in the manufacture of generic drugs and associated APIs
“GDUFA is aimed at putting FDA's generic drugs program on a firm financial footing …to ensure timely access to safe, highquality, affordable generic drugs.” -Janet Woodcock, MD, FDA House Subcommittee on Health, Feb. 9, 2012 6
Status Check of GDUFA To Date • Some good foundations have been made but execution is still lacking • To date approximately $621 million has been invested into the program which resulted in decreased transparency, decreased certainty for industry and decreased access for patients • The next round of investment, around $299 million, is coming soon • FDA met GDUFA goals to hire new staff, bringing on more than 950 hires as a result of the GDUFA program • Industry has experienced unforeseen “pain” during the foundation building period for the new OGD and GDUFA program and patients have experienced delays in accessibility of products at the first available date 7
Status Check on GDUFA Goal of Improved Transparency •
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One of the three key tenets of GDUFA was enhanced transparency “…improving FDA’s communications and feedback with industry in order to expedite product access.” Communications and feedback are not occurring, placing industry in the dark, unable to plan for the future and provide patients with the medicine they need counter to the purposes of Hatch Waxman. – While industry has noticed an improvement in increased Information Requests, overall feedback with project management staff continues to suffer. FDA has still not revised its internal communication MAPP which significantly limits what FDA staff may share with applicants GPhA firmly believes that neither FDA nor industry anticipated meaningful communications process would essentially be shut down and remain extremely limited for the first half of the GDUFA cycle. FDA’s promise to provide industry with Target Action Dates for all pre-October 1, 2014 has still not occurred. 8
Status Check on GDUFA Goal of Improved Access Through More Timely Approvals • • •
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Since passage of GDUFA, OGD’s median review time to approval has continued to rise. When the program was negotiated in FY2011, median review time to generic approval was at 30 months. Since then, median review times increased to 31 months in FY2012, 36 months in FY2013 and an estimated 42 months in FY2014 and 2015 appears to be tracking at 48 months! Overall approval numbers (including both tentative and final) are down as well, with 619 approvals in FY2012, declining to 535 in FY2013 and dropping to about 500 approvals for FY2014. So far, FY2015, is around 346 approvals to date. First generics continue to miss approval on earliest legally eligible date, counter to Hatch Waxman’s purpose. Overall filing compared to approval data shows a continually increasing gap: 2600 submissions, 1100 approvals (FY13-present).
*Numbers do not include the yet to be released data contained in the FY 14 Performance Report 9 for Congress
Serious Patient and Marketplace Impact • In the last year and a half, it is estimated that the U.S. health care system lost over $3 billion in savings due to first generic approval delays. Collectively these first generic applications have experienced median approval times estimated at 50 months. • Increasing health care costs impacts access to pharmaceuticals for key patient populations. • Timeliness and number of generic drug approvals have a direct impact on generic drug price competition as provided in the aptly named Patent Term Restoration and Generic Price Competition Act (aka Hatch Waxman) which has historically provided the framework to allow more than a trillion dollars in savings to the U.S. healthcare system. • Post-GDUFA the value of 180-day exclusivity likewise continues to erode as companies are forced to forfeit their exclusivity due to review delays. 10
Regulatory Science Funding • $20 million annual allocation for FDA Regulatory Science Initiatives. • No industry suggestions provided by GPhA has been implemented to date. No transparent process is in place for consideration or discussion of agency and industry priorities. • Additional emphasis needed to ensure proper and meaningful scientific dialogue exists for development of complex generics. 11
Conclusion • Patient access to generic pharmaceuticals are in jeopardy unless and until improvements in GDUFA implementation are made by FDA. • Uncertainty leads to shortages, price increases and market disruption. • Communications with industry and formation of a true partnership are critical. • Patients and US healthcare system deserve to see IMMEDIATE IMPROVEMENTS in transparency and approvals of the backlog and year 12 applications. • Industry and Congress continue to await FDA’s FY2014 performance report on GDUFA. • GPhA welcomes the opportunity to continue to work with FDA to ensure the key purposes of GDUFA – improved Access, Transparency and Safety are achieved as intended.
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