Reprimands in the UK, opioid manufacturers face another investigatory group, and registration processes for Nevada representatives, all in this week’s Compliance News in Review.
Ready or not, Fall is here! Leaves are turning, football is back, the oppressive heat of Summer is fading, and pumpkin spice everything is available. We are certainly fans of Autumn here in the offices of the News in Review and we’re ready to break out the flannel shirts, boots, and maybe a knit cap to enjoy the cooler evenings ahead. We are also fans of compliance! So, grab a pumpkin spice latte and settle in to this edition of the Compliance News in Review.
A nip in the air, and a nip at the marketing practices of several companies by the ABPI. The industry organization reprimanded Pfizer, Novartis, Astellas UK, Astellas Europe, and TOR Generics for breaches of its Code. Pfizer and Novartis were both cited for misleading promotion, and unclear materials used by representatives. Astellas UK and Astellas Europe voluntarily admitted that prescribing information for several of their products omitted references to adverse events. Lastly, TOR Generics was accused of promoting an unlicensed product, which was expected to be a prescription-only product, in a public magazine.
A new team is investigating opioid marketing. 41 state attorneys general formed a coalition to investigate opioid manufacturers and distributors. The group subpoenaed several top manufacturers, and wholesale distributors Amerisource, Cardinal, and McKesson. The AGs want to know if manufacturers deceived healthcare professionals about product efficacy and addictiveness.
Time to turn over a new leaf in Nevada. The state published draft procedures for the registration of pharmaceutical representatives. Individuals who work in Nevada for at least five days a year and communicate with healthcare professionals, or participate in the activities listed below, must register with the state’s Department of Health and Human Services (DHHS):
- Marketing of prescription drugs to healthcare providers, pharmacists or pharmacy employees, and employees of medical facilities
- Meeting with healthcare providers to answer questions about product use and benefits, or to provide discussion and product information and resources to those providers or other decision makers while representing the manufacturer or supporting promotional efforts of the manufacturer
- Distributing FDA regulated product samples and product information
These activities are excluded under the law:
- Attending a conference in Nevada that is not exclusively marketed to Nevada healthcare professionals
- Activities related to clinical trials, investigational drugs, or Risk Evaluation and Mitigation Strategies
- Activities performed by wholesale distributors who do not represent a single manufacturer
Companies are required to notify DHHS as employees are hired and terminated, and employees must be registered with DHHS within 30 days of hire.
With that, we wrap up this edition of the Compliance News in Review and head outback to roast marshmallows and make smores! If you can’t join us by the fire pit, we’ll catch you back here for our next issue.
Thanks for reading!