Proposed Human Generic Drug Performance Goals and Procedures Fiscal Years 2013 through 2017

On 6th December 2011, the FDA released its draft document, Proposed Human Generic Drug Performance Goals and Procedures Fiscal Years 2013 through 2017, which the Generic Pharmaceutical Association (GPhA) expressed its strong support for a day later.  The proposed programme will see the FDA receive nearly US$1.5 billion over five years in supplemental funding through the Generic Drug User Fee Act (GDUFA), a generic industry equivalent of the branded industry’s Prescription Drug User Fee Act.  The FDA’s draft paper notes that the overall purpose of the programme is to ensure that participants in the US generic drug system comply with US quality standards, and to increase the likelihood that US consumers gain access to generics in a timely manner.  The programme has three key aims:

  • Safety; ensuring that industry participants are held to consistent quality standards;
  • Access; expedite the availability of generic drugs through improved review times;
  • Transparency; enhance the FDA’s ability to protect Americans in the global supply environment by requiring the identification of facilities involved in the manufacture of generics.

Proposals to introduce a generic drug user fee programme have been in the offing for a number of years, including proposals in federal government budgets, and have been tied to efforts to stem the growing backlog of pending ANDA applications.  Quite simply, the FDA’s funding has not allowed it to hire enough qualified staff to deal with the increasing number of generic drug applications entering the system.  It is a proposal that has received a guarded response, however.  Members of Congress in early 2006 questioned the wisdom of gathering fees from an industry that the FDA is charged with overseeing, and have questioned whether this would lead to increased industry influence at the agency.  The GPhA at the time was also guarded.  Whilst it encouraged efforts to clear the backlog, the organisation was not entirely convinced that user fees would lead to faster approval times, noting that the generic system, unlike the branded industry, had additional roadblocks in the form of legal challenges through patent infringement action and even citizen petitions lodged with the FDA.  The GPhA’s view on the issue has always been that a programme to introduce user fees must be balanced with measurable results.

The FDA held a public meeting on the subject in September 2010 in order to gather stakeholder input on the development of a user fee programme, and has held further meetings in the intervening period up until this latest announcement.  The arguments regarding a user fee programme were essentially split between two camps: greater speed in reviewing ANDAs and greater safety, with proponents of the latter argument concerned that increased speed would not address issues such as inspections of overseas manufacturing plants.

FDA Proposals

The draft proposals now tabled by the FDA do appear to address both the speed and safety concerns, leading to the GPhA endorsing them.  With regard to speeding up approvals, the draft proposes that the FDA will review and act on 90% of complete electronic ANDAs within 10 months after the date of submission, and will review and act on 90% of all ANDAs and ANDA prior approval supplements regardless of current review status pending on 1st October 2012 by the end of FY2017.  This will eliminate the current backlog.  The draft also proposes measures to increase inspections of both finished dosage form manufacturing facilities and active pharmaceutical ingredient facilities, in the US and abroad.  The draft proposes employing a risk-adjusted biennial cGMP surveillance inspection model with a goal of achieving parity of inspection frequency between foreign and domestic establishments in FY2017.

The proposals will need to be put before Congress before they can be implemented, and this is by no means a certainty.  However, the proposals represent a sensible approach to speeding up generic drug approvals without compromising safety, the implications of which could go beyond the generics industry.  The GPhA has argued that the proposals provide a good opportunity to overhaul the Food, Drug and Cosmetic Act; currently, the act requires American drug manufacturers to undergo cGMP inspections every two years, but does not require the same for overseas manufacturers.  The GDUFA proposals could lead to this being changed for both the generic and branded industries.

Article source: World Generic Markets, kindly provided by Ian Platts, editor.

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Filed under: Generics News

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