qordata thought leaders and subject matter experts share their insights and experiences
In the American medical drug and device industry, poor compliance practices never go away. They keep coming back to haunt you in newer and more alarming ways. Take Insys Therapeutics, Inc. In less than three years, it has gained infamy for using unethical means (read: violation of good pharmaceutical compliance practices) to sell its opiod, Subsys. What unfurled was a media nightmare (for Insys) and a cautionary tale for everyone else. Here’s a summary of the company’s legal ordeals: Used off-label promotion and false claims for a drug only approved for cancer patients Made over $2.7 million in general payments to HCPs and HCOs. (Insys paid $6.2 million to settle this lawsuit in 2015) In December 2016, prosecutors in Boston […]
If you think your medical drug/device manufacturing company is too: Small Famous Distant from the spotlight or Historically compliant To come under fire, think again. The recent case of CMS terminating an HCO’s Medicare Benefits, is a cautionary case in point. According to a report published on 28th September 2017, a California-based Eye Surgery and Laser Center will experience a termination of its Medicare provider agreement with CMS, effective 12th October 2017. The involuntarily termination follows CMS’ announcement of finding the surgery center “not in compliance with regulatory requirements for participation as an Ambulatory Surgery Center in the Medicare Program.” The Center, which was named after one of the region’s most well-respected achievers, has been in establishment since 1959.
Samuel D. Warren and Louis D. Brandeis’ 1890 article “The Right To Privacy” has become classic reading for 21st century data professionals. But as we discovered in an excellent webinar with Denise Farnsworth Chief Privacy Officer, Senior Corporate Counsel at Jazz Pharmaceuticals, Brandeis’ article forms only half of the data privacy story. What data privacy means to you will, of course, be influenced by why you want it. In contrast to the USA, where the motivation to secure individual privacy was largely economic, arguments favoring data privacy in EU focus on personal safety. After all, it was less than a century ago that a breach of personal data security spelled out life-threatening consequences in the region. What does this mean […]
The approach towards data privacy in EU makes consideration towards consent revocation an imperative. If a physician revokes consent, individual versus aggregate spend figures need to be recalculated, and they will show the corresponding changes. Thus, historical consent rate figures may not be an accurate indicator of transparency in that specific market, or even attitude shifts towards transparency. Interest groups that don’t examine consent from this angle tend to make hasty judgments on transparency. The fourth estate is a repeat offender, often citing (or misrepresenting) published data as a way of drawing public attention to “Big Pharma’s Big Money.” Not only does this present a distorted view of pharmaceutical spend activity to the public, but it also discourages relatively open […]