On February 9-11, 2015, a record 765 attendees descended on Miami Beach for the Generic Pharmaceutical Association (GPhA’s) Annual Meeting. Craig Wheeler, President, Momenta Pharmaceuticals, Inc. delivered the welcoming message, calling GPhA “the frontline of defense” to advocate for a “level playing field.” Wheeler said that FDA’s building an enhanced infrastructure for generic drugs has harmed the generic drug industry with longer delays than ever but hopes there will be something to look forward to in 2015. GPhA is concerned about risk evaluation and mitigation strategies (REMS) blocking generic drug entry, FDA requiring new safety labeling for generic drugs before their referenced products, new exclusivity periods for innovator products, and unresolved issues for biosimilars, such as naming, substitution, and reimbursement. Wheeler noted aside from biologics, there are other complex target drugs without competition, where GPhA can help the industry work with FDA. Wheeler also observed that while some generic manufacturers are getting larger and larger, there are significant changes in leadership at companies, which will also occur in GPhA with the President and CEO, Ralph Neas, stepping down later this year.

Ralph Neas delivered the GPhA State of Association Address, where he applauded GPhA for its record attendance, growing staff (now 22), and progress in such issues as biosimilars where state substitution bills were opposed, and fight against FDA’s proposed rule regarding new safety labeling for generic drugs. Neas said the generic drug industry wants access, transparency, and quality from FDA’s GDUFA initiatives, where the industry has not seen the success that was expected from the program yet though remaining hopeful. Neas said that GPhA formed a new group to help develop quality metrics and has made progress with spotlighting the issue of REMS abuse by generic drug companies. Neas also said that GPhA helped block 298 potentially-harmful bills that would have harmed substitution for generic drugs or biosimilars and hopes to block the Dorman Therapies Act that could provide an unprecedented 15 years of exclusivity to a new category of “dormant” drugs and biologics. Neas explained that he is stepping down in September 2015 to provide GPhA with enough time for a smooth transition, and he plans to pursue other opportunities for non-partisan election reform, teaching and writing, and affordable health care involvement.

Kathleen “Cook” Uhl, M.D., the Director of the Office of Generic Drugs (OGD), then delivered in the Keynote Address her “path to success with GDUFA.” Uhl thanked the industry for its patience, feedback, and input with GDUFA. Uhl noted that OGD has been a “victim of its own success” by the ever-increasing number of new abbreviated new drug applications (ANDAs) submitted each year, which has created a tremendous backlog, disjointed review, and fragmented discipline deficiencies in the past. OGD is now revved up for meeting its new GDUFA goal dates for the ANDAs submitted after October 2014, while at the same time reducing the backlog and reviewing applications from cohort years 1 and 2 of GDUFA that do not have goal dates but will have target action dates (TADs). Uhl said that FDA has to move the “freight” of about 4,000 pending ANDAs (about 3,300 with FDA and 700 waiting for industry replies), which she called “riding the wave.”

Uhl said to fix the backlog and address the high volume of ANDAs, FDA had to restructure its programs within the Center for Drug Evaluation and Research (CDER). Some of the changes have included elevating OGD to its own “super office,” creating a new Office of Product Quality (OPQ) in January 2015, creating a new information technology (IT) platform, and a new Office of Policy within OGD, headed by Keith Flanagan. FDA has exceeded its hiring goals with GDUFA, which included not only hires in OGD but also other offices in CDER and the Office of Regulatory Affairs (ORA).

Indeed, Uhl described OGD as the “hub” driving changes in generic drug reviews with a new CDER Lifecycle Management Board, a GDUFA Command Center, a GDUFA Review Implementation Team, a GDUFA Steering Committee, and more. And the efficiency improvements have showed their worth by shortening accepted for filing dates to an average 27 days for the year three cohorts and real-time communications, where FDA has already responded to 68% of the backlog (90% require responses by 2015). OGD is reaching out to industry for rapidly-correctable deficiencies to help provide for an efficient approval process, but Uhl noted if industry does not respond quickly, there may be more refusal to receives (RTRs) and approval delays.

Uhl said that OGD is assigning TADs to pending ANDAs, applying some TLC to some first big generic products in a ”peel the onion,” layer-by-layer approach, and including updated communications to industry in new formalized procedures. Part of the process includes additional launch planning for first big generic products, where OGD will tell companies a response is coming, a “pre-action notification,” without indicating whether it will be an approval. OGD has been engaging in quarterly meetings with GPhA and has lots of interaction, such as weekly telecons and more frequent online posts of new developments.

As part of the “formula for success,” Uhl said that OGD has now increased review capacity, has prioritized first generics, and provided for coordinated reviews and inspections, while meeting the metrics for cohort years 3, 4, and 5 under GDUFA. Uhl said that OGD will meet its GDUFA goals, as CDER has always taken pride in meetings its user fee commitments.

Following Uhl were presentations on the ongoing “reverse settlement” or “pay-for-delay” settlements in ANDA patent litigations and Doug Long’s IMS Health, Inc. generic industry trends. Long, IMS’s Vice President, Industry Relations, noted that the pharmaceutical industry had double-digit growth due to innovation and price increases, with 60% of the growth from specialty pharmaceuticals. Long reported that generic drug medications have saved millions, despite some price inflation due to additional regulatory quality controls, controls for controlled drug substances, customer consolidation, and fewer new product launches.