Thanks to the explosion of social media networks like Twitter and Facebook, drug and medical device companies now have a direct link to users of their products. Although the U.S. Food and Drug Administration (FDA) addresses legal and regulatory issues associated with off-label promotion medical devices and drugs, it has only recently directed enforcement towards companies that who are utilizing these new mediums to promote their products.
Many Product Liability policy forms contain an exclusion for loss arising out of the dissemination of information in violation of any law, regulation or order of any governmental authority. It will be interesting to see how insurers will address social media and if they will consider using these new mediums a form of off-label promotion. Ropes & Gray LLP will host a webinar tomorrow on the regulatory challenges posed by social networking and online media tools, to explore FDA’s approach to enforcement in this area and provide practical advice for companies to consider when developing their compliance strategies. Check it out “Using Social Media Outlets for Drug Promotion“.
Over the past few weeks we have received various warnings from cargo and transit insurance companies along with FreightWatch International regarding potential thefts of drugs and pharmaceutical shipments. Intelligence was released last week by the N.E. Transportation Security Council that five members of a Florida-based cargo theft crew were arriving in New Jersey on Wednesday with the intent of committing a cargo theft somewhere in the Northeast (NJ, PA, MD, NY, IL, CT, OH). Assuming they already scouted the target location in the past and will commit the theft over the next several days or the Thanksgiving holiday weekend. Back on November 10th, a full truckload of pharmaceuticals was stolen from a rest area in Kentucky when it was left alone alongside the exit ramp because the parking spaces were full. The truck was reportedly left unattended Read more…
A decree goes into effect March 14th requiring minimum insurance for any company conducting clinical trials in Italy. The new requirements were established by Italy’s Ministry of Labor, Health and Social Policy to safeguard participants in clinical trials conducted wholly or in part in that country.
The requirements state that the insurance policy must cover any civil liability of the sponsor and investigator without excluding any damage which may have been caused by accident or attributed to negligence. In addition to death and permanent and/or temporary injury, damages include economic loss directly resulting from participation in the clinical trial. Read more…
Thanks to the explosion of social media networks like Twitter and Facebook, drug and medical device companies now have a direct link to users of their products. Although the U.S. Food and Drug Administration (FDA) addresses legal and regulatory issues associated with off-label promotion medical devices and drugs, it has only recently directed enforcement towards companies that who are utilizing these new mediums to promote their products.
