Washington: The US Food and Drug Administration, or FDA, has approved 18 generic drugs made by Ranbaxy Laboratories Ltd even as the US investigated whether the company fabricated data to get its medicines cleared.
FDA has been aware of the allegations for at least 18 months, the energy and commerce committee of the US house of representatives said in a document on its website. Ranbaxy, India’s largest drug maker, has brought to market nine of the 18 drugs, among them copies of Bristol-Myers Squibb Co.’s cholesterol drug Pravachol and Johnson and Johnson’s non-prescription allergy pill Zyrtec, according to the company.
In trouble: Ranbaxy’s research and development centre in Gurgaon. Ranbaxy officials have denied charges that the company fabricated data to get its medicines cleared in the US. Photograph: Scott Eells / Bloomberg
Lawmakers and former FDA officials are now questioning why the agency continued to trust Ranbaxy’s data on new products after learning of the allegations.
The energy and commerce committee, which oversees the FDA, is probing why the agency didn’t act on the information, described by the justice department in the court motion last month seeking documents from the firm.
FDA should have halted approval of Ranbaxy’s drug applications because the agency “wouldn’t be confident of the accuracy and reliability of the information in the applications,” said Mary Pendergast, a former FDA deputy commissioner who is now a consultant for drug and medical device companies. “They might be approving a product that ought not be approved.”
Pendergast based her comments on the allegations in the court motion, not independent knowledge of the case, she said in a telephone interview this week.
She said clients of her firm, Pendergast Consulting in Washington, have included Johnson and Johnson and Genentech, Inc.
On 3 July, the government asked a US district court judge in Maryland to force the company to turn over audits completed by a contractor, which Ranbaxy later agreed to provide. According to the motion, the government is investigating allegations including conspiracy, false statements and health care fraud.
Ranbaxy “strongly denies” the claims in the motion, the Gurgaon-based drug maker said in a 14 July statement.
FDA collected more than 200 samples of products sold by the company, and all were found to meet required specifications, the drug maker said. “The allegations are baseless,” Ranbaxy said. “The company’s business in the US continues as normal.”
FDA approved 18 Ranbaxy drugs since a government search of the company’s New Jersey facilities on 14 February 2007, said Ranbaxy spokesman Charles M. Caprariello.
The company will not sell three of the products, and six aren’t being sold yet because of patents held by brand-name drug makers, he said.
Daiichi Sankyo Co. Ltd won approval from the Indian government this month to buy Ranbaxy for as much as $4.7 billion (Rs20,069 crore). Tokyo-based Daiichi Sankyo said this week that it will begin its tender offer for Ranbaxy on 16 August.
Ranbaxy fell 11%, the biggest drop in seven years, in Mumbai trading after the US court motion was disclosed last month. It fell 0.26% to Rs499.05 on Wednesday and has gained 18% this year through Wednesday.
Ranbaxy markets 65 medicines in the US, and its sales in the country were $386 million last year, according to Caprariello. US patients filled 52 million prescriptions with Ranbaxy’s generic drugs in 2007, according to IMS Health Inc., a Norwalk, Connecticut market research firm.
The company has the right to distribute the first copies of New York-based Pfizer Inc.’s cholesterol pill Lipitor, the world’s best-selling drug with $12.7 billion in 2007 sales, in November 2011, after the patent expires.