FDA Says Ranbaxy Falsified DataFeb 27, 2009 | Parker Waichman LLP A facility operated by Ranbaxy Laboratories, the much maligned generic drug maker, has been accused of faking data and test results in approved and pending drug applications. The Food & Drug Administration (FDA) has halted the review of drug applications made at Ranbaxy's Paonta Sahib plant in India because of the issue.
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. According to a report in the Washington Post, the Paonta Sahib plant makes 25 FDA approved drugs. While the FDA would not provide a list of the drugs involved, the agency maintained that drugs are not carried in U.S. pharmacies. The FDA is not planning on issuing a drug recall, the Post said.
As we reported in September, the FDA had imposed an import ban on 30 different Ranbaxy drugs because of the agency’s concerns about the “seriousness and extent” of violations of manufacturing standards at Paonta Sahib and a second Ranbaxy facility in India. At the time, officials said they were concerned about whether the practices employed at the facilities could ensure purity of drugs they made.
According to The Wall Street Journal, most of the falsified data involves required tests to prove drugs are stable over a certain time period. The problems were discovered during a 2006 inspection , and included drug samples meant for required stability testing stored in refrigerators even though the samples should have been stored at room temperature. Logbooks also didn't identify which samples were in the refrigerator or how long they had been there.
This is just the latest Ranbaxy scandal that we've reported in recent months. In addition to the September drug ban, US prosecutors filed a motion in federal court in Maryland last July 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. Prosecutor also accused the company of concealing violations of good manufacturing practice regulations from FDA.
The FDA's conduct in dealing with Ranbaxy has also come into question. In a letter to the agency last July, Rep. John Dingell and Rep. Bart Stupak, both Michigan Democrats wrote that court documents related to the Justice Department probes of Ranbaxy indicated that for 18 months the FDA was aware of problems 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.