After Ranbaxy, US FDA turns the heat on Actavis

The US Congressional committee, which is inquiring into the country's Food and Drug Administration’s (FDA) handling of drug-marketing approvals of India’s leading drug-maker Ranbaxy, has extended its probe into similar permissions given to Iceland’s Actavis.

The committee on Wednesday sought all data pertaining to the approvals given since 2003 to the products of Actavis, a generic medicine manufacturer.
 

UNDER PRESSURE

• India is one of the raw material sourcing hubs for Actavis
• The inquiry does not pertain to any of its Indian facilities, though the committee has sought details of all the raw material suppliers to Actavis

The committee has given US FDA two weeks to respond. Incidentally, India is one of the raw material sourcing hubs for Actavis. The company, which has a raw material development unit and a contract research organisation in India, had a raw material manufacturing facility in southern part of the country.

However, this inquiry does not pertain to any of its Indian facilities, though the committee has sought details of all the raw material suppliers to Actavis.

In an October 8 missive to FDA Commissioner Andrew C von Eschenbach, the committee members John D Dingell and Bart Stupak said, “Following on the heels of disclosures regarding gross improprieties at Ranbaxy Laboratories, the entire production of another generic drug manufacturer (Actavis) has been recalled.”

The members wanted list of all the laboratories where Actavis medicines were tested and details of all its raw material suppliers, including those to its subsidiaries in the last five years. A day before the committee’s decision, Ranbaxy had announced that it has provided all necessary data to the US FDA on all the ongoing inquiries against its products and the processes followed in some of its manufacturing facilities.

Pursuant to Ranbaxy’s submission, the US Department of Justice, which had moved an information seeking motion in the District Court of Maryland, had withdrawn the motion.

The committee’s move against Actavis is yet another indication of the growing pressure on the USFDA to revisit the approvals it has given for low-cost generic medicine manufacturing facilities the world over, industry experts said.