Ranbaxy Allegations Put FDA in SpotlightJul 24, 2008 | Parker Waichman LLP
Lawmakers probing allegations that generic drug maker Ranbaxy Laboratories Inc. imported defective drugs to the US have sent a letter to Food & Drug Administration (FDA) Commissioner Andrew von Eschenbach, demanding information on each drug Ranbaxy has approval to market here. Rep. John Dingell and Rep. Bart Stupak, both Michigan Democrats who head up the House Committee on Energy and Commerce, wrote that they were concerned that the FDA knew about problems with Ranbaxy drugs for months, but did nothing.
Based in India, Ranbaxy is one of the 10 largest generic-drug producers in the world and has been operating in the States since 1995. In February, federal agents raided the US corporate offices of Ranbaxy in New Jersey, as well as a manufacturing facility in the state. The raid - and criminal investigation - was prompted, in part, by problems uncovered in FDA inspections a year earlier at the company’s plant in Paonta Sahib, India. That inspection found inconsistencies in the company’s manufacturing processes and maintenance of data.
Earlier this month, US prosecutors filed a motion in federal court in Maryland alleging that Ranbaxy forged documents relating to an investigation into the quality of the company’s drugs sold in the this country. The investigation is also looking into allegations that Ranbaxy made weak or adulterated HIV drugs that were given to thousands of AIDS patients in Africa. Prosecutors have accused the company of concealing violations of good manufacturing practice regulations from FDA.
In their letter, Dingell and Stupak wrote that court documents related to the investigations indicate that for 18 months the FDA was aware of these allegations but "did nothing to remove the suspect products from the market, or even notify the pharmacists in this country".
"If true, these statements would call into serious question whether the leadership of the Agency ... [has] met even the minimum requirements" of the FDA's primary mission under the Federal Food Drug and Cosmetic Act, the letter said.
The Congressmen have given the FDA two weeks to respond to their letter.