France publishes its first public reports related to physician payments, several companies pay out millions in settlement fines, medical affairs professionals discuss their changing role in compliance, and Massachusetts releases a notice regarding the reporting of the same spend information required under the Sunshine Act.
Break out the mortarboard and fire up Pomp and Circumstance, it’s that time of year again. has arrived. There’s nothing quite like watching the graduates cross that stage, receive their diploma and bask in the achievement. Here’s hoping they enjoy the moment before they have to face the harsh realities of the next phase of life. (Remember that moment when we realized that “nap time” in first grade did not include a mat? Welcome to the real world!) With that in mind, we proudly present this week’s graduating class…and this week’s compliance News in Review.
A transfer story from France leads our parade of worthy stories. France has published the first public reports of industry transfers of value (TOVs) to healthcare professionals, as required by the French Sunshine Act. To manipulate this database you’ll need to dust off your old French text book, or quickly invest in a Rosetta Stone course, because there is no option to switch to an English (or any other language for that matter) translation. The company information is all .txt files that are practically impossible to read, but if you know some HCPs in France you’d like to search for, that information is slightly more reader friendly…except for the whole being in French thing. Oh well, the information is there for the linguistic and inquisitive among us. According to the folks at Policy and Medicine, there has been little press coverage of the release of the data.
Don’t get to comfortable with the French Sunshine Act though, it appears there may be a major change coming soon. Recently, the Ministry of Social Affairs of Healthcare issued a draft order that would modify some of the regulations. One modification will simplify the details reported about HCP arrangements. Another will lessen the level to which companies need to protect HCP information. Finally, a change to the schedule initially set up to declare the benefits and the conventions has been proposed.
Several industry companies are facing unexpected fees and fines. Medtronic will pay $9.9 million to settle allegations under the False Claims Act. According to the government, the company used a variety of payment schemes to induce physicians to use its pacemakers and defibrillators. The company is alleged to have paid physicians to speak at events to increase referral business, created marketing/business development plans for physicians at no cost, and provided sporting event tickets to physicians.
Boehringer Ingleheim has agreed to pay $650 million to settle 4,000 lawsuits involving the drug, Pradaxa. According to a BI spokesperson, the average payout per settlement will be $162,500. Plaintiffs claim the company didn’t adequately warn patients of the risks associated with use of the blood thinner. The company says the drug’s safety has been repeatedly demonstrated, and the settlement does not change the drug plays in patients’ lives.
GSK has agreed to pay $105 million to 44 states and the District of Columbia to settle claims they illegally promoted two antidepressants and an asthma drug. In the agreement with the states, the company agreed to changes in its incentives to sales people, not use paid physicians to promote products, and to refrain from making deceptive or misleading statements in its advertising.
Chicago is throwing its cap in the ring and has filed suit against five manufacturers of highly addictive painkillers. In a suit similar to one filed by several California counties, Chicago is claiming the companies overstated the benefits and downplayed the risks associated with the use of the pain drugs. The suit says the companies violated laws related to consumer fraud, misleading advertising and false claims. In addition to the civil penalties and punitive damages, the city is seeking to reclaim profits associated with the illegal marketing activity.
As the regulatory landscape changes, medical affairs personnel are becoming more important in conversations with HCPs and more involved with health economic and outcomes research (HEOR). Within these two areas, concerns regarding off-label use of products are becoming a hot issue. Speakers at last week’s World Congress said their companies have evolved their policies on responding to unsolicited requests for off-label information. Compliance issues related to HEOR include the nature of the studies used and whether or not the company is providing payers with balanced information regarding the safety and efficacy of products.
Massachusetts has finally moved the tassel on some of its HCP spend reporting requirements. The state recently released a Notice of Federal Preemption, which stated that the Department of Public Health could not require pharmaceutical and med device companies to report the same spend information that is required by the Sunshine Act.
And with that, we bring this week’s ceremony to a resounding close. We wish all of the graduates out there good luck with whatever life holds for them next. Toss those caps in the air everyone and have a great week! We’ll see you right back here next week.