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FDA expands efforts to test quality of generics

Monitoring programme to ensure drug copies are equivalent to branded medicines
FDA headquarters White Oak

Armed with additional funding from generic drug user fees, the US FDA has started monitoring the quality of generics in the market to ensure they are equivalent to their reference products.

The agency has been carrying out low-level testing of generics for years, but lacked the resources to conduct a more systematic analysis of their quality, safety and efficacy. Now a Bloomberg report suggests the monitoring exercise has been ratcheted up via a series of funding awards to academic institutions.

The $20m programme - which has been prompted by growing concerns about the quality of imported generics given the FDA's limited inspection resources - got underway last year and will run through 2017. It will reportedly involve both imported and domestically-produced medicines.

Post-market evaluation of generic drugs topped the list of the FDA's research priorities for fiscal 2014 under the Generic Drug User Fee Act (GDUFA), published towards the end of last year.

Noting that generics accounted for 84 per cent of prescription in 2012, the FDA said it wanted to focus on key therapeutic areas where concerns have been expressed about the substitutability of generics for brand name drugs, including those used to treat epilepsy, immunosuppression, attention-deficit hyperactivity disorder (ADHD) and cardiovascular disease

The agency is also conducting research into generics of the antidepressant Wellbutrin XL (bupropion). This brand was originally marketed by GlaxoSmithKline in the US but was sold to Biovail (now Valeant) in 2009. Two years ago a generic version sold by Teva as Budeprion XL was taken off the market after the FDA determined its efficacy was reduced.

Other specific drugs targeted by the research will include generics of Pfizer's cholesterol-lowering therapy Lipitor (atorvastatin), after the discovery of impurities in generics that affected its efficacy, according to the report. The FDA is also funding research on GlaxoSmithKline's Advair (fluticasone/salmeterol) now that a potential route to approval of generic equivalents has been created.

In addition to verifying therapeutic equivalence via brand to generic switching studies, the agency has also earmarked funds for research into surveillance methods for generics, as well as trying to understand patient perceptions of generic drug quality and effectiveness.

In tandem with the monitoring programme, the FDA is also beefing up its ability to regulate drug producers overseas, for example signing an agreement with its counterpart in India to improve collaboration and information-sharing.

Article by
Phil Taylor

24th February 2014

From: Sales, Regulatory, Healthcare

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