Ranbaxy Case Shows FDA May Not Be Doing All It Can, Congressman Says

NEW YORK (CBSNewYork/AP) — How safe is the nation’s generic drug supply?

As 1010 WINS’ Mona Rivera reported Tuesday, U.S. Rep. Steve Israel (D-N.Y.) of Long Island thinks the recent Ranbaxy case shows the Food and Drug Administration may be asleep at the wheel.

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“We had a company in India that was engaged in outright fraud, that was introducing into the U.S. untested, potentially unsafe drugs, and it took not the FDA to uncover this, but a former employee of the company who was a whistleblower,” Israel said.

Israel called for better FDA oversight of foreign drug makers.

Ranbaxy, the maker of generic Lipitor and other popular and generic drugs, admitted to lying and falsifying safety data. The company agreed earlier this month to pay a record $500 million in fines and penalties.

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The case concluded a years-long federal investigation into Ranbaxy’s manufacturing deficiencies. The FDA had earlier barred Ranbaxy from importing more than 30 different drugs made at factories in India and, in 2011, struck a deal that required the company to ensure that data on its products are accurate, undergo extra oversight from a third party and improve its drug-making procedures.

Ranbaxy admitted as part of the deal that it sold impure drugs developed at two manufacturing sites in India. Prosecutors said the batches of adulterated drugs included generic versions of an antibiotic and other medications used to treat a severe type of acne, epilepsy and nerve pain.

The U.S. government insists no patients were apparently harmed.

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