Generics Industry Update: 2016 GPhA Fall Technical Conference

The GPhA Fall Technical Conference in North Bethesda, Maryland was an opportunity for the US Food and Drug Administration (FDA), to report annual progress, reiterate proper protocol regarding information submission and to detail any changes in policy and organizational structure that have been made during past year.  In turn, representatives from industry were afforded the opportunity to provide feedback to the FDA about how regulation policies are affecting the pharmaceutical industry, as well as to seek guidance in cases where policy may be unclear.  The past year has been a time of great change – the FDA has continued to undergo a massive reorganization, negotiations have been underway to create the framework for the second phase of the Generic Drug User Fee Act (GDUFA) and new FDA policies will soon require all submissions to be filed electronically.  These changes along with many other topics were outlined and discussed during three days of presentations and panel discussions at the North Bethesda Marriott between October 24th and 26th.  


Current State Of Affairs

The conference kicked off Monday afternoon with Chester Davis, CEO and President of GPhA, providing opening remarks.  Mr Davis addressed the recent media coverage of the drug industry and predatory price hikes and referenced a recent Gallup survey that showed the American public to have an overall negative view of the pharmaceutical industry.  He ensured that the generic pharmaceutical industry has been part of the solution to curb rising drug prices – currently generic drugs make up 89% of the US pharmaceutical market by volume and only 27% by cost.  Generic drug substitution saved US consumers 227B$in 2015, or roughly 4 billion dollars per week.  Even greater savings are predicted once US biosimilar approvals become more commonplace; one model predicts an additional 250B$ in savings by 2020 thanks to biosimilar substitution alone.  Mr Davis spoke of recently completed infliximab studies in Norway and Denmark where drug safety and efficacy in patients was shown to be unaffected following a switch from innovator to biosimilar medication.  While parties with varying interests have offered different solutions to the problem of rapid, frequent branded drug price increases, Mr Davis reminded listeners that everyone agrees that enhanced competition is the solution to keeping prices in check.  All drugs recently making news for large price hikes are old off-patent branded medicines with some barrier to generic entry; commoditized products see no such increases and often sell for pennies a pill.  While pharmaceutical industry representatives state publicly that reduced drug costs would benefit the American consumer, Mr Davis warned listeners that brand drug representatives are working behind the scenes to fight legislation that would reduce anti-competitive abuses being used to delay generic drug entry.  Mr Davis also warned that some solutions to the rising drug prices currently being proposed by lawmakers would trigger government action based on price increase percentage, and that these programs would unfairly target companies that made small price increases to very inexpensive medicines.  While legislative change is important to prevent companies from repeatedly hiking drug prices by thousands of dollars, organizations like GPhA whose members understand the inner workings of the pharmaceutical should be consulted regarding new regulations so that the desired effect is achieved.


Several representatives of the FDA also provided opening remarks, beginning with Pharmaceutical Quality Program Director Alonza Cruse.  Mr Cruse talked of the challenges involved in ensuring that millions of imported product lines are safe for consumers.  The FDA is dealing with the ever-increasing workload through greater use of mutual reliance of European inspection results, better training for US compliance inspectors and risk-based inspections that document companies with exceeding quality.  Mr Cruse said that the FDA will strive for more consistency, transparency and better communication in future dealings with the industry it regulates.  Center for Drug Evaluation and Research (CDER) director Janet Woodcock provided an overview of the current size and distribution of her department, as well as which elements of pharmaceutical regulation fall under CDER jurisdiction.  The CDER jurisdiction is quite broad, and touches on drug advertising, REMS, adverse event tracking and recalls among other things.  CDER has recently increased focus on drug compounder regulation, as many warning letters and recalls have resulted from compounders being unable to provide sterility assurance.  The office is also serving as the point of contact for Joe Biden’s Cancer Moonshot initiative to accelerate cancer research, as well as taking a lead role in the FDA Safe Use Initiative.  Dr Kathleen Uhl, Director of the Office of Generic Drugs, spoke about GDUFA – both a refresher on terms of the original program and some data to outline the program’s accomplishments.  Dr Uhl reported that the FDA has met or exceeded every goal laid out in GDUFA – the agency has responded to over 90% of ANDAs and PASs received and cleaned up an ANDA backlog despite submissions to the agency exceeding predicted totals.  While there are approximately 4000 ANDAs which have been submitted to the FDA that are currently unapproved, these submissions do not represent the “backlog” that existed prior to GDUFA implementation.  Nearly half of those unapproved ANDAs are currently “with industry”; the FDA has reviewed those submissions and returned them to the filers for additional information.  ANDAs currently with the agency are mostly recent submissions or resubmissions that have required multiple review cycles; only a small percentage of unapproved ANDAs represent submissions which were not addressed within GDUFA timeline goals.  Dr Uhl explained that for the great majority of ANDA submissions, a Complete Response letter is the first FDA action.  While NDA PDUFA submissions received first cycle approval 95% of the time in 2015, ANDAs receive first cycle approval less than 10% of the time, leading to delayed approvals and more work for both reviewers and filers.  Dr Lucinda Buhse, Director of the Office of Pharmaceutical Quality (OPQ), closed the Monday session with an overview of the OPQ objectives.  In addition to performing pre-approval inspections, the office plays a role in ANDA approvals, combating drug shortages and managing post-marketing drug quality and risk issues.    

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