Overseas API vendor qualification under US FDA spotlight says H&H

By Gareth Macdonald

- Last updated on GMT

Related tags Food and drug administration Pharmaceutical drug

US drug firms’ qualification of overseas API vendors will be subject to increased FDA scrutiny in the coming years according to a new industry report by analysts Hogan & Hartson (H&H).

The Washington DC legal firm said that despite 80 per cent of the Food and Drug Administration (FDA) warning letters issued in the last year being sent to domestic manufacturers, the agency's December “Beyond our Borders” initiative indicates a change in focus.

H&H cited several recent good manufacturing (GMP) warnings issued to Chinese active pharmaceutical (API) suppliers, including Qingdao Jiulong Biopharmaceuticals and its subcontractor Shanghai No 1, as evidence that agency priorities are shifting.

Increased FDA scrutiny of ex-US suppliers would go some way towards addressing recent Government Accountability Office (GAO) criticism of the agency’s failure to keep accurate data about overseas drug facilities​.

Additionally, asking US importers to play a greater role in proving the quality of ex-US manufacturers may reduce the number of facilities the FDA must inspect, which would help alleviate concerns about the cost of the agency’s overseas activities.

More aggressive use of GMP warnings

H&H’s research also highlighted an increasing trend in the FDA to become more aggressive with its use of GMP warning letters and “bundle” drug manufacturers’ wider business violations in with quality concerns.

The authors suggest that more and more the agency is using warnings to notify pharmaceutical firms if their products lack the necessary approvals or are misbranded or to raise concerns about promotional activities.

They reference several GMP warning issued to Deltex Pharmaceuticals, Cascadia Manufacturing, Omega Tech Labs and Civic Center Pharmacy as a basis for their contention.

While all these warnings were sent last year a quick glance at recent FDA letters​ issued to Mallinckrodt Pharmaceuticals Group, Glenmark Generics and Boehringer Ingelheim would seem to confirm the observation for misbranding transgressions at least.

H&H go on to predict that: “as the agency continues to face an increasingly large number of enforcement priorities with limited resources, we believe that this bundling approach…will become more common​.”

The full H&H report can be found here.

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