Despite the fact that generic drug maker Ranbaxy Laboratories, Ltd. is in the midst of a scandal and a US investigation, the Food and Drug Administration (FDA) went ahead and approved 18 of its drugs. Ranbaxy is accused of conspiracy, falsifying statements, and healthcare fraud. On its Website, the House Energy and Commerce Committee states that the FDA has been aware of these allegations for no less than 18 months. “Allegations from reliable sources and supporting documents indicate a pattern of systemic fraudulent conduct, including submissions by Ranbaxy to the FDA that contain false and fabricated information,” the Justice Department wrote.
Late last month we reported that lawmakers probing allegations that Ranbaxy imported defective drugs into the US sent a letter to FDA Commissioner Andrew von Eschenbach, demanding information on each drug Ranbaxy has approval to market here. Representatives John Dingell and 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.
In early July, 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 also accused Ranbaxy of concealing violations of good manufacturing practice regulations from the FDA.
Ranbaxy, India’s largest drug maker, has already brought to market nine of the 18 drugs, including copies of Bristol-Myers Squibb Company’s cholesterol drug Pravachol and Johnson & Johnson’s nonprescription allergy pill Zyrtec. But lawmakers and former FDA officials are wondering why the FDA continued to trust Ranbaxy’s data on new products despite the scandal. Also, the Energy and Commerce Committee—which oversees the FDA—is looking into why the FDA didn’t act on the information, which was described by the Justice Department in the court motion last month. According to Mary Pendergast, a former FDA deputy commissioner, the FDA should have stopped Ranbaxy’s drug applications approvals because the FDA “wouldn’t be confident of the accuracy and reliability of the information in the applications…. They might be approving a product that ought not be approved.”
According to the July 3 motion, Ranbaxy’s drugs may contain too much or too little of their main ingredients, the Justice Department wrote. The government is now reviewing data regarding falsification of documents that stated Ranbaxy’s generic drugs are absorbed at the same rate and extent as the brand names. Such information is used by the FDA to determine if generics should be approved for sale, which eliminates the need to require the full clinical trials needed for clearance of new brand-name drugs. The “FDA doesn’t need to wait for a conviction to freeze review of somebody’s application,'’ said Areta L. Kupchyk, who helped decide whether to halt approvals when she worked as an FDA lawyer. ”So long as there are significant suspicions that the data is questionable, FDA can freeze the review,'’ Kupchyk added.
Many are wondering why this did not occur.
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