It’s turning out to be a good month so far for Medtronic Inc.
The company is showing Wall Street that it can play tough on health providers by going toe-to-toe with its purchasing organizations. (So much for Minnesota Nice.) And now Fridley, Minnesota-based Medtronic (NYSE: MDT) says it’s resolved U.S. Food and Drug Administration warning letter issues at two manufacturing facilities — clearing the way for new product launches.
“We are encouraged that the action plans implemented by our teams have resolved the observations identified by the FDA in both warning letters,” William A. Hawkins, Medtronic’s chairman and CEO, said in a news release.
The warning letters involved Medtronic’s Mounds View, Minnesota, location, the headquarters of the company’s Cardiac Rhythm Disease Management business, and its Juncos, Puerto Rico, plant, which is a Neuromodulation, Diabetes and Cardiac Rhythm Disease Management business location. The warning letters resulted from FDA inspections of the plants in late 2008 and 2009.
Analysts were reporting last year that the warning letters were holding up launches of products including the Revo MRI-friendly pacemaker and Protecta defibrillator. The FDA approved the Revo last month, clearing the way for its product launch.
Protecta has been under an “approvable letter,” which means there are additional requirements the company needs to meet before the product is approved, said Medtronic spokesman Brian Henry. Three other Medtronic devices have also been under similar approvable letters: InterStim Therapy for Bowel Control, a nerve stimulation system meant to treat severe fecal incontinence, the Consulta/Syncra pacemaker, and the Attain Ability Plus left ventricular cardiac vein lead.
Getting the warning letter issues resolved helps clear the way for FDA approvals and resulting U.S. product launches, which Henry says are expected to be imminent.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The news sent Medtronic stock up 46 cents per share, or 1.16 percent, to $40.10 in Wednesday morning trading, even as the Dow Jones Industrial Average was slightly down.
