There has been growing concern in the U.S. over the issue of importation, pertaining not only to the importation of prescription drugs for personal use, but drugs, or drug components manufactured overseas and imported into the U.S. (i.e., heparin). The FDA on Tuesday announced the issuance of Warning Letters to Ranbaxy, the Indian generic giant.
The concern, on the part of the FDA, was the manufacturing practices at two specific plants—Dewas and Paonta Sahib (including the Batamandi unit). The FDA termed the action preventive in nature and other manufacturing plants run by Ranbaxy were not affected.
While the agency stated that people should not stop taking their medications produced by Ranbaxy, the company was told that until the current good manufacturing practice (cGMP) deficiencies were resolved at each of the two facilities and the plants come into compliance, FDA's drug compliance office will recommend denial of approval of any new drug applications (NDAs) and abbreviated new drug applications (ANDAs) that list the Paonta Sahib or Dewas plants, respectively, as the manufacturer of APIs or finished drug products.
This is pretty strong stuff and demonstrates an effort on the part of the agency to take a proactive stance on the part of public health. After all, if they do this and it prevents harm, it is difficult for them to prove a negative, unlike the situation in China, where it has seemed the agency is always in reactive mode to a budding crisis.
It is not clear why, if the agency thinks there is a potential problem with the drugs being manufactured by Ranbaxy, it is not advising patients to switch to other generics - especially since it went so far as to list the drugs that are affected.
The company in question expressed some surprise, according to the statement released by Ranbaxy:
“Ranbaxy is very disappointed in the action FDA has taken today. The company has responded to each concern FDA has raised during the past two years and had thought that progress was being made. We are, however, pleased that FDA's testing and review led the agency to conclude that there is no reason to question the safety or effectiveness of Ranbaxy's drugs. The company has just received the warning letters that FDA has issued and has not had the opportunity to review those concerns that FDA has determined are unresolved. Once it has had an opportunity to review the issues, the company looks forward to continuing to cooperate with FDA to resolve the remaining issues.”
Ranbaxy was also careful to note that the warning letters and Import Alert do not apply to Ranbaxy’s other facilities including its three manufacturing facilities in the U.S., Ohm’s Laboratories facilities in New Brunswick, NJ, North Brunswick, NJ, and Gloversville, NY, from which Ranbaxy delivers some 59 drug products to the U.S. healthcare system, including: Simvastatin, Acyclovir, Minocycline, Clindamycin, Lorazepam, Loratadine-D, Cetirizine, Acetaminophen Extended release tablets, Lisinopril and Zolpidem.
Is this a one-off for the FDA to demonstrate it is stepping up to the proactive side or is it the beginning of a continuing trend? With so much of the focus being on Chinese imports, those of us watching FDA actions will be interested to know if the new inspectors being installed in China with great support from Congress will also result in such proactive actions or whether the agency will continue to have to respond to emerging public health crises out of China.
Mr. Senak is an attorney with over twenty years of experience offering a blend of law, communications, public health and public relations. He authors a blog called Eye on FDA ( www.eyeonfda.com).