Gilead manufacturing under investigation by US authorities
pharmafile | June 14, 2011 | News story | Manufacturing and Production | Department of Justice, Gilead, manufacturing compliance, pharma manufacturing
Gilead Sciences is being investigated by the US authorities over the manufacturing and distribution of some of its products, and is ‘cooperating’ with the inquiry.
On Friday the drugmaker confirmed it had received a subpoena from the US Department of Justice for documents related to the “manufacture, and related quality and distribution practices”, for a number of its top medicines.
The probe is looking at Gilead’s actions in the context of both civil and criminal law, said the firm in a press release.
The request applies to the company’s HIV therapies Atripla (efavirenz/emtricitabine/tenofovir), Emtriva (emtricitabine), Truvada (tenofovir/emtricitabine) and Viread (tenofovir); hepatitis drug Hepsera (adefovir); and pulmonary arterial hypertension drug Letairis (ambrisentan).
The US Attorney’s Office for the Northern District of California is also requesting information on one of Gilead’s investigational drugs, namely its fixed-dose combination of Truvada and Johnson & Johnson’s Edurant (rilpivirine).
At present it is not clear whether the subpoenas relate to an ongoing FDA investigation into Gilead’s manufacturing facility in San Dimas, California.
Last September, Gilead was sent an FDA warning letter detailing a number of problems at the site, including problems with the maintenance of aseptic processing conditions which could lead to a risk of products becoming contaminated.
The agency also cited a lack of effective quality control systems and inadequate environmental monitoring programmes. One of the drugs mentioned in the DoJ probe – Viread – was cited in the warning letter, although most of the citations involved other products such as the injectable antifungal AmBisome (liposomal amphotericin B).
Phil Taylor
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