- The Washington Times - Friday, August 1, 2008

The Justice Department is investigating whether Ranbaxy Laboratories Ltd., which supplies generic drugs to the U.S. market and to President Bush’s global AIDS initiative, has falsified data, followed sub-par manufacturing practices and distributed counterfeit medicine.

“The government is investigating Ranbaxy and certain of its employees concerning possible violations of federal laws,” states a July 3 motion filed in U.S. District Court in Maryland by Justice Department officials and federal attorneys, who are trying to force the company to turn over certain documents. “The government has reason to believe that these violations have resulted and continue to result in the introduction of adulterated and misbranded products into interstate commerce with the intent to defraud or mislead.”

Ranbaxy, which is based in India, is one of the top 10 generic drug companies in the world, supplying medicine for many ailments to more than 100 countries and posting global sales of more than $1.5 billion in 2007, according to the court filing.

The filing stated that “allegations from reliable sources indicate a pattern of systematic fraudulent conduct” by the company. The allegations include that in its application process, the company submitted fabricated data to the Food and Drug Administration for generic drugs to be distributed in the U.S. and anti-retroviral drugs to be distributed in other countries as part of the President’s Emergency Plan for AIDS Relief.

The administration’s AIDS program funds treatment and prevention programs in Africa and around the world. Mr. Bush on Wednesday signed legislation expanding the program, calling for an additional $48 billion over the next five years. The AIDS initiative funds the manufacture and distribution of some of Ranbaxy’s HIV drugs in foreign countries, as do groups such as the World Health Organization, the World Bank and the Bill and Melinda Gates Foundation, according to Justice Department.

In court papers filed July 14, Ranbaxy officials said they already provided many documents and that they are in the process of producing more.

The company also issued a statement in which it notes that no charges have been filed despite a lengthy investigation and that the FDA found no problems after gathering and testing more than 200 random samples of Ranbaxy products.

“Under these circumstances the company finds that the allegations are baseless,” the company said. “The company’s business in the United States continues as normal. Ranbaxy remains committed to providing high quality generic medicines.”

The Justice Department also is investigating whether Ranbaxy destroyed data it was supposed to retain to try to conceal violations of good manufacturing practices, and whether it produced sub-par drugs by blending unapproved ingredients with approved ones, and using less active ingredients than had been approved by the FDA.

Meanwhile, leaders of the House Energy and Commerce Committee are focusing their disdain on the FDA and have begun investigating the approval process for Ranbaxy drugs.

In a July 22 letter to the FDA commissioner, committee Chairman John D. Dingell and Rep. Bart Stupak lamented that, according to the Justice Department motion, FDA knew of alleged problems for at least 18 months and didn’t remove Ranbaxy products from the market or alert pharmacies.

“If true, these statements would call into serious question whether the leadership of the Agency … have met even the minimum requirements of due diligence,” the two Michigan Democrats wrote, asking the FDA to provide documents on the matter.

Republican committee staff is working with Democrats on the investigation, an aide said.

Neither the Justice Department nor the FDA could comment on the investigation.

At the Justice Department’s request, the court on Tuesday put the case on hold for two months to give Ranbaxy time to produce documents.