Ranbaxy probe includes AIDS relief meds

Ranbaxy can't be happy. The Indian company's stock is way down for the second day in a row, on news that the U.S. investigation into its operations [1] includes allegations that it made weak or adulterated HIV drugs given to thousands of AIDS patients in Africa. The Indian company has U.S. government contracts to supply low-cost antiretrovirals for AIDS relief, but Justice Department and FDA investigators allege that some of those drugs were poorly made, unstable, or too weak to be effective.

Meanwhile, the company acceded to the government's requests for documents, saying it would turn over the papers. The disputed documents are audit reports from Parexel, a consulting firm that examined Ranbaxy's plants. You'll recall that investigators claim at least some of these documents were fabricated to cover up the fact that Ranbaxy had made substandard products. The company had claimed that the audits were "privileged" and were thus confidential.

Ranbaxy also reiterated its conviction that its sale to Daiichi Sankyo [2] remains on track and that its licensing deals--including a recent pact with Pfizer [3] to produce an authorized generic version of Lipitor--aren't affected by the probe, either. And the company says it "knows of no evidence to support" the U.S. allegations, which it acknowledged as "serious."

- read the Wall Street Journal story [4]
- see the WSJ Health Blog item [5]

Related Articles:
Feds say Ranbaxy faked data [1]
Daiichi Sankyo acquires Ranbaxy in $4.6B deal [2]
Overseas drugmaking goes unsupervised [6]
Probe reveals convoluted supply chain [7]