Friday, February 09, 2007
Regulatory Risks
From the world of medical devices, a world that is interesting but generally outside the scope of this blog, because there have to be limits...
Nonetheless, this caught my eye: “A class-action shareholders' suit has been filed against U.S. device maker Cyberonics, the law firm Goldman Scarlato & Karon said Thursday…The complaint alleges that Cyberonics failed to disclose and misrepresented material information known to the company regarding review and approval by the Food and Drug Administration of a new use for the company's Vagus Nerve Stimulation device to treat depression.”
I love to read the Management Discussion and Analysis section of pharma company annual reports, because therein the company acknowledges risks that investors should be aware of, including regulatory risks. Go to Pfizer’s or Merck’s or Genentech’s or any publicly-traded pharma or biotech’s website, find the Investors section (there will be one), and download the Annual Report (or 10K or 10Q). As a regulatory affairs professional, it’s satisfying to see in print that what you’re doing is important to the company’s bottom line.
Anyhow, back to Cyberonics. According to the suit, they didn’t disclose their regulatory risks properly. It’s not clear (to me, anyhow) whether the alleged lack of disclosure occurred in an annual report, a press release, or some other type of communication. Doesn’t matter, for my purposes. I just wanted to take the opportunity to encourage regulatory affairs professionals to read the MDA sections of pharma annual reports.
Nonetheless, this caught my eye: “A class-action shareholders' suit has been filed against U.S. device maker Cyberonics, the law firm Goldman Scarlato & Karon said Thursday…The complaint alleges that Cyberonics failed to disclose and misrepresented material information known to the company regarding review and approval by the Food and Drug Administration of a new use for the company's Vagus Nerve Stimulation device to treat depression.”
I love to read the Management Discussion and Analysis section of pharma company annual reports, because therein the company acknowledges risks that investors should be aware of, including regulatory risks. Go to Pfizer’s or Merck’s or Genentech’s or any publicly-traded pharma or biotech’s website, find the Investors section (there will be one), and download the Annual Report (or 10K or 10Q). As a regulatory affairs professional, it’s satisfying to see in print that what you’re doing is important to the company’s bottom line.
Anyhow, back to Cyberonics. According to the suit, they didn’t disclose their regulatory risks properly. It’s not clear (to me, anyhow) whether the alleged lack of disclosure occurred in an annual report, a press release, or some other type of communication. Doesn’t matter, for my purposes. I just wanted to take the opportunity to encourage regulatory affairs professionals to read the MDA sections of pharma annual reports.
# posted by Anonymous, RAC @ 4:38 PM 
