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FDA making progress but still needs to conduct more inspections Posted 12/06/2015

A report from the US Office of the Inspector General (OIG) published in May 2015 has found that although the US Food and Drug Administration (FDA) has made progress on the oversight and inspection of manufacturers of generics, it still needs to conduct outstanding pre-approval inspections of generics makers, which could lead to more timely approval of these drugs.

The OIG carried out the study into FDA at the request of the US Congress, due to concerns about the safety and quality of generics produced by foreign manufacturers, after a number of recalls of such drugs. In 2012, nearly 80% of prescriptions filled in the US were for generics, making the safety and quality of such drugs paramount for the country.

The OIG analysed FDA data for inspections and registered manufacturers of generics for the period 2011–2013 to determine the number and types of inspections carried out by the agency. In addition the OIG also analysed FDA data to determine whether manufacturers listed on approved applications had registered with FDA as required.

The analysis found that FDA increased its pre-approval inspections of manufacturers of generics by 60% between 2011 and 2013, from 149 in 2011 to 211 in 2012 and 243 in 2013. However, it did not conduct all of the pre-approval inspections requested by its own generics application reviewers during this time period. In fact, 24% of pre-approval inspections requested in 2011 had not been conducted as of 31 December 2013, all of them for foreign generics makers.

During the same period, the total number of overseas inspections grew from 101 in 2011 to 113 in 2012 and 142 in 2013. However, the proportion of inspections of foreign generics makers, compared with domestic firms, decreased from 60% in 2011 to approximately 50% by the end of 2013.

Despite FDA now having extra resources in the form of generics user fees [1], FDA attributed the failings to a lack of resources, staff availability and priority being given to pre-approval inspections that could impact drug shortages.

Regarding registration of generics makers, the report found that FDA has made progress but the registry is incomplete. The OIG’s analysis found that 45 of the 432 companies with approved abbreviated new drug applications in 2013 did not match entries in the agency’s registry of generics makers. Of those, 62% were foreign generics makers.

The OIG therefore recommended that FDA:

  1. Conduct outstanding pre-approval inspections of manufacturers of generics, where appropriate, which could lead to more timely approval of these drugs.
  2. Ensure compliance with the requirement for manufacturers of generics to register with FDA as a complete and up-to-date registration database would facilitate the implementation of the agency’s plans for conducting inspections.
  3. Use its authority to request records in lieu or in advance of an inspection. Such requests could increase FDA’s capacity for inspections, and review of the records could be completed in advance, which could free up staff time during the onsite portion of the inspection.

FDA concurred with these recommendations.

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FDA announces two actions to combat drug shortages

1.   GaBI Online - Generics and Biosimilars Initiative. FDA gives details of generic drug user fees [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 12]. Available from: www.gabionline.net/Policies-Legislation/FDA-gives-details-of-generic-drug-user-fees 

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Source: OIG

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