There have been countless recalls of faulty drugs and medical devices in the pharmaceutical and device industry. Some have been the result of malicious actions by external parties, while others can be attributed to production faults or other random incidents. No matter what the cause, the manufacturer is always placed directly in the spotlight and how they respond can have lasting effects on their reputation.
The most recent to capture the media’s attention – as they inevitably always do – is a voluntary recall of around 600,000 contact lenses made by New York-based CooperVision, Inc. Federal health officials claim that an “undefined residue” on the lenses has caused a range of eye problems, from blurred vision to painful corneal tears.
CooperVision has come under heavy criticism for their slow response to the recall. This delay has resulted in threats by the FDA to issue a public health warning and sweeping negative media coverage for CooperVision. As a voluntary recall, the Food and Drug Administration, which regulates contact lenses as a class III medical device, has only limited authority to force CooperVision into action, with much of the onus for notification and action placed on the individual retailers.
The Food and Drug Administration is wrestling with how to best implement the Biologics Price Competition and Innovation Act. The agency is writing regulations that will set the exact rules for gaining biosimilar approval and has scheduled a meeting to obtain public input on the regulatory pathway that is being considered. The meeting is set for November 2-3 and will be held at FDA’s facility in Silver Spring, Maryland. The full meeting announcement can be found 
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Newsflash from Sweden: The father of IVF (in vitro fertilization) has won the Nobel Peace Prize for medicine.