Wednesday, July 3, 2013

AG Schmidt: Settlement protects prescription drug quality

TOPEKA, Kan. ---- Kansas has joined in a legal settlement with an India-based generic pharmaceutical manufacturer accused of selling adulterated drugs in the U.S. marketplace, Kansas Attorney General Derek Schmidt said today.

A federal investigation found evidence that that the drug company, Ranbaxy, knowingly manufactured, distributed and sold generic pharmaceutical products with strength, purity and/or quality below the standards required by the U.S. Food and Drug Administration. The products at issue consisted of 26 generic pharmaceutical products manufactured at two facilities in India. The drugs included prescription products intended for children, such as the antibiotic amoxicillin.

“We take seriously the sale of drugs that fall short of U.S. regulatory standards,” Schmidt said.  “Americans expect that pharmaceuticals will always be subject to rigorous quality control and will meet high standards.”

As a result of the sale of adulterated medications, fraudulent claims were submitted to the Medicaid program for purchase of the substandard drugs. For that reason, the settlement orders that $323,992 be refunded to the Kansas Medicaid program.

Ranbaxy also entered into a consent decree with the federal government to address outstanding manufacturing quality and data integrity issues at the two Indian manufacturing plants in question. The company has agreed to implement actions to correct its violations and to ensure that the violations do not occur again.