The US Food and Drug Administration has accused India-based drug manufacturer Ranbaxy of falsifying data in both approved and pending drug applications.
All drug applications from Ranbaxy’s Paonta Sahib facility have been halted as a result, using what is known as the Application Integrity Policy. The company was warned by the FDA last year about “deviations from US current Good Manufacturing Practice”.
“The FDA’s investigations revealed a pattern of questionable data raising significant questions regarding the reliability of certain applications, and this warrants applying the Application Integrity Policy,” says Deborah Autor, director of the Office of Compliance at the FDA’s Center for Drug Evaluation and Research, in a statement released yesterday. “Today’s action reflects the FDA’s continued vigilance and its steadfast commitment to safeguarding the public’s health.”
Ranbaxy says it is analysing the FDA’s letter and adds, “The FDA has said it has no evidence the drugs on the market are substandard and also that they comply with specifications upon testing. No products from Ranbaxy’s other manufacturing facilities are included in the AIP.”
Comment on the situation below the fold.
The FDA Law blog says action under the Application Integrity Policy is “unusual”:
FDA takes such regulatory action under the Agency’s AIP procedures when FDA believes that a company’s actions raise significant questions about the integrity of data in marketing applications.
Bloomberg highlights the plight of Ranbaxy’s owner, Japan’s Daiichi Sankyo Co., whose shares “fell to a record low in Tokyo”:
Daiichi Sankyo dropped 9.5 percent to 1,680 yen at the close on the Tokyo Stock Exchange, the lowest level since the company took its current form in September 2005. Ranbaxy fell 18 percent to 169.85 rupees.
“The factory issue seems to have deeper roots than we expected,” Yasuhiro Nakazawa, an equities analyst at Mitsubishi UFJ Securities Co., said by telephone. “It raises concern whether the decision affects reviews of drugs, such as the generic version of Lipitor.” Ranbaxy, based in Gurgaon, 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.
The Wall Street Journal’s Health Blog takes a similar tack:
It’s been one thing after the next since Daiichi’s bid for Ranbaxy became public last June. A month later, a criminal investigation by the Justice Department over allegedly forged documents came to light. Ranbaxy strongly denied those allegations.
In September, the FDA banned imports of drugs from that same Paonta Sahib plant and another owned by Ranbaxy due to manufacturing issues. And just last month, Daiichi said it would take a nearly $4 billion hit on the Ranbaxy deal after the company’s shares had fallen well below the purchase price.
The Washington Post puts the incident in context of ongoing criticism of the FDA:
“For the past three years, FDA possessed credible information that Ranbaxy had engaged in a pattern of fraudulent behavior, but they continued to drag their feet while American lives were at risk,” said Rep. John D. Dingell (D-Mich.) of the Committee on Energy and Commerce, which has been investigating Ranbaxy. “The Ranbaxy case is yet another example of the need for significant reform at the FDA.”