Ranbaxy’s Atorvastatin Recall: Will Glass Shards Nick FDA’s Reputation?
Less than a year after signing a consent decree to resolve compliance problems, the company is forced to stop manufacturing its generic version of the best-selling cholesterol drug. For FDA, the issue poses a public relations challenge since it touches on several areas where the agency has recently been criticized – generic drug quality, manufacturing oversight and drug shortages.
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Undaunted by a spate of negative news, Ranbaxy CEO Arun Sawhney says his mandate is clear: to build a strong reputation for Ranbaxy. In a discussion with PharmAsia News, Sawhney says he regrets the errors of the past that led to quality lapses, but says changes have been made to avoid similar fumbles in the future.
Mylan played a pivotal role in crafting the formula to create Generic Drug User Fees. The selection of Rep. Tim Murphy (R-Pa.) to chair the House Energy & Commerce Oversight Subcommittee should help assure that Mylan’s perspectives continue to play an important role.
OGD Director Geba says generic manufacturers still suffer from extensive quality problems, but GPhA officials argue the industry is doing fine and communications with the agency need to be more uniform.