US generic drug user fee proposals mean more facilities inspections
Karen Finn, 24-Jan-2012
Manufacturers of active
pharmaceutical ingredients and finished dosage forms destined for
the American market will be subject to more frequent current good
manufacturing practice inspections if Congress adopts the Food and
Drug Administration's proposals for a new a Generic Drug User Fee
Act (GDUFA).
The FDA sent the proposals to Congress on 13 January, but it had
already hashed out the fundamentals in an agreement
with the generic drugs industry last year. Specifically,
manufacturers and facilities have agreed to pay about $299m
annually in each of fiscal years 2013 to 2017. In exchange for the
fees, the FDA has committed to meeting
performance goals that were also made public for the first time
on the 13th.
A main aim of the programme is to ensure that foreign and domestic
participants in the US generic drug system are held to consistent
high-quality standards. To this end, one of the FDA’s performance
goals is to conduct risk-adjusted biennial cGMP surveillance
inspections of generic API and generic finished dosage form
manufacturers.
The objective is to achieve parity of inspection frequency between
foreign and domestic firms in FY 2017. By "parity", the agency
means inspection at an equal frequency, plus or minus 20 per cent,
with comparable depth and rigour of inspection.
This goal goes some way towards addressing recommendations
contained in a 2010 Government Accountability Office report, which urged
the agency to inspect foreign establishments at a frequency
comparable to that of domestic facilities.
The inspections are not only intended to address concerns about
safety and supply chain integrity – they are also part of the FDA’s
strategy to improve patients' access to generics. The agency is
facing a major backlog of generic drug applications (ANDAs). The
bottlenecks that occur in the review process are largely due to the
increasing number of applications requiring inspections of foreign
sites combined with a lack of available resources to carry out the
inspections.
The FDA will thus prioritise inspections of establishments
associated with ANDAs that are otherwise approvable or eligible for
tentative approval, except for an outstanding inspection, as well
as establishments associated with ANDAs that have not been
inspected previously. This will contribute to the agency’s goals of
virtually eliminating the backlog and reducing ANDA review
times.
To improve the FDA’s ability to protect the global supply chain,
the FDA will also require facilities involved in the manufacture of
generic drugs and associated APIs to be identified.
The user fee programme alone will not address the agency's
resourcing woes. Under another
initiative launched to address the problem, the FDA and the
European Medicines Agency have agreed to share work on inspections
of manufacturing sites in each other's territories. This should
reduce the burden of inspections for manufacturers and also shift
the authorities' inspection capacity to other regions.
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