FDA Examines Drug Quality from Overseas Facilities.

pillsThe United States Food and Drug Administration has stepped up enforcement efforts against overseas exporters of drugs to the U.S. in light of recent reports of drug quality and manufacturing issues. Facilities in India, the second largest exporter of prescription and over-the-counter drugs, have been under especially heavy scrutiny.

Last year, Ranbaxy Laboratories paid $500 million to resolve civil and criminal actions for improper manufacturing, storage and testing of generic drugs. Dinesh Thakur, a former Director & Global Head of Research Information & Portfolio Management at Ranbaxy, reported the misconduct at Ranbaxy and received $48 million from the government as a whistleblower.

Ranbaxy was the largest drug manufacturer in India by revenue. Drugs from two of its facilities were banned by the FDA in 2008. Two more overseas facilities operated by Ranbaxy were banned more recently, in September 2013 and January 2014. The most recent inspection of the Toansa facility found staff retesting active pharmaceutical ingredients after they failed quality tests.

Indian drug maker Wockhardt has also had imports from two manufacturing plants suspended by the FDA in the last year, according to Bloomberg. The FDA discovered issues with quality testing at the facilities, located in Chikalthana and Waluj, during inspections.

In addition to quality testing concerns, counterfeiting has also been a major issue. Counterfeit drugs often don’t contain the active pharmaceutical ingredients which provide medical benefits to patients from the drug’s consumption. China is believed to be a large source of counterfeits but the FDA has had difficulty inspecting facilities there in the past.

Quality concerns overseas are troubling because the majority of drugs consumed in the United States now have some foreign component. Nearly 80% have active pharmaceutical ingredients from foreign countries, usually China or India, and nearly 40% are manufactured outside of the United States. The percentage is even higher when name brand prescription drugs are excluded. More than forty percent of OTC and generic pharmaceuticals are made in India.

Problems with overseas manufacturing may have developed because of disparities between domestic and foreign inspection rates. The FDA conducts strict inspections of drug manufacturing facilities in the United States every two years and has authority to conduct surprise inspections. In 2011, a GAO study found foreign drug manufacturers were inspected far less frequently. They estimated that overseas facilities were inspected once every ten years. As a result, Congress passed legislation to give the FDA broader authority to conduct inspections of drug facilities overseas. If they are refused entry for an inspection, the FDA can now block entry of drugs from the facility into the United States.

The FDA is also establishing an Office of Pharmaceutical Quality to improve the detection of quality issues in brand name, generic and over-the-counter drugs. The office will be focused on enforcing existing requirements and will not impose new quality restrictions. The interim director of the office is Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA.

These problems have also come to the attention of Congress. There is a Congressional hearing set for February 26th in order to further investigate substandard generic drugs from overseas. Cleveland Clinic doctor Harry Lever, among others, will testify about his experience with cardiology drugs manufactured in India.

The Young Law Group represents whistleblowers bringing forth claims of health care fraud under the False Claims Act. If you wish to report evidence of drug quality problems at a pharmaceutical manufacturer in the United States or abroad, please call 1-800-590-4116 or fill out the contact form for a free, confidential consultation.

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