Giuliani to argue Ranbaxy’s case in US
pharmafile | September 18, 2008 | News story | Sales and Marketing |Â Â US, genericsÂ
Indian generics firm Ranbaxy has hired former New York mayor Rudolf Giuliani to help reverse an FDA block on imports of its drugs.
The FDA declared on 16 September that it would block the import of 30 generic drugs into the US because of potential safety concerns.
The US regulator said continuing concerns about lax manufacturing standards at Dr Reddy’s two manufacturing sites in India had led it to impose the ban.
The FDA says no dangerous or defective products from the factories have been found, but said it was taking the action as a precaution.
Shares in the Indian pharma group fell as a result of the announcement, as the US is responsible for around a quarter of Ranbaxy’s revenues.
In a statement, Ranbaxy said: “The company has responded to each concern FDA has raised during the past two years and had thought that progress was being made.”
The company nevertheless pledged to resolve the problem.
Ranbaxy says Giuliani, a lawyer by training, would provide advice and review compliance issues in relation to the case. It clearly hopes his legal expertise and high profile will help see the issue resolved as quickly as possible, as a block on its products will hit its revenues hard and allow competitors to gain market share.
It is the second time in less than three years that the FDA has issued a warning letter to Ranbaxy.
The company said it was “very disappointed” with the decision, which relates to drugs from two Ranbaxy plants in India – Dewas and Paonta Sahib.
It does not apply to Ranbaxy’s other facilities including its three manufacturing bases in New Jersey and New York from which it delivers 59 products to the US market.
Quality control was the key area of concern at the Indian plants, with the FDA deeming Ranbaxy’s procedures to be inadequate in a number of areas, including measures to prevent cross-contamination between different drugs.
The move does not mean the products have had their marketing approval withdrawn, only that imports of drugs from those two manufacturing facilities will be blocked.
Banned products include simvastatin, fenofibrate – for adults with high serum triglyceride levels – and hepatitis B treatment lamivudine.
The FDA said that other manufacturers can meet market demand, with one exception – it will not detain shipments of antiviral ganciclovir oral capsules since Ranbaxy is the sole US supplier.
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