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FDA Chief to Visit India Amid Generic Drug Concerns

Head of FDA Plans Visit to India as Concerns Grow Regarding Generic Drugs Manufactured There

generic drugsAmid rising concerns about the quality of generic drugs manufactured in India, FDA head Margaret A. Hamburg announced that she would head to the country to investigate some troubled manufacturers.

Several generic drug manufactures in India have come under fire in recent years because of violations of FDA regulations. Manufacturers Ranbaxy Laboratories and Wockhardt Ltd were both banned from selling prescription generic drugs in the US after federal inspectors found the companies had retested drugs’ efficacy to gain favorable results.

Hamburg’s trip to India, scheduled for February 10th to 18th, is aimed to strengthen relations between the FDA and Indian regulators.

“The FDA’s ongoing engagement with our regulatory counterparts in India is critical to our ability to effectively promote the health and safety of American and Indian consumers,” Hamburg said.

“I look forward to enhancing our existing relationship and identifying additional opportunities for collaboration,” she added.

This is also another step toward regulating generic drugs. For years, the FDA did not have authority to regulate generic drug manufactures due to a legal tie-in with brand name counterparts. However, in 2012, the FDA was granted the power to collect fees for problems with generic drugs from their manufacturers – and in November of last year, the FDA proposed a rule to allow generic drug manufacturers to change their labels to reflect side effects that brand name drugs did not have to list.

In June of this year, the Supreme Court upheld a 2011 decision that generic drug manufacturers were not liable for personal injury caused by their products, because generic drug companies must legally have the same safety labels as their brand-name counterparts. If a patient ends up with a personal injury due to safety problems with a drug they have been prescribed, they can sue the brand name manufacturer, but they cannot sue the generic drug company for misinformation about safety. Brand name companies, also, are able to independently update their safety and warning information, while generic drug companies have had to wait until new information about the original drug was released.

“Now, with the generic industry having grown up, most people are taking generic drugs,” said Dr. Janet Woodcock, the F.D.A.’s head of drug evaluation and research, in a telephone interview. “It’s really time to level the playing field.”

However, in June of last year, the Supreme Court upheld a long-standing decision in PLIVA v. Mensing that said generic drugs are not liable for personal injury side-effects. The case – Mutual Pharmaceutical Co. v. Bartlett – in fact made tort suits and personal injury cases more difficult to file against generic drug manufacturers.

Generic drug manufacturers, including those in India should they sell in the US, are subject to some FDA regulations which can help prevent personal injury. However, bringing a lawsuit forward can be very difficult.

The Strom Law Firm Helps with Personal Injury Cases Related to Brand or Generic Drugs

If you have been harmed, or a loved one has been harmed or killed by a defective product or drug, whether brand name or generic, the attorneys at the Strom Law Firm can help. You may be entitled to compensation through a personal injury lawsuit. We offer free, confidential consultations to discuss the facts of your case, so contact us today. 803.252.4800.



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