Preparing for Increased Government Enforcement

If you didn’t have a chance to tune into the BIO webinar on What to Do and Not Do as Regulatory Enforcement Increases for Life Sciences Communications, here are insights and perspectives shared by two industry insiders who spoke at the event.

Bob Dean, an FDA Insider, is the current VP of Commercial Regulatory at Myovant Sciences.  Bob spent 15 years at FDA, 10 of those as Division Director of FDA’s OPDP Division of Advertising and Promotion Review.

Howard L. Dorfman has served in various senior legal and compliance roles in national and global pharmaceutical and biotech companies since 1978. In addition, Howard is an Adjunct Professor at Seton Hall Law School. Mr. Dorfman’s areas of expertise include FDA regulatory law, fraud and abuse, healthcare compliance programs, risk management, and product liability.

Don’t Be Lulled into a False Sense of Security; It’s a New Era of Enforcement Because We Can’t Go Back

Even though we are not back in the heyday when indictments were in the billions, settlements are still occurring just without fanfare. There were more new False Claims Act (FCA) cases filed in 2022 than in any year in history. The Department of Justice (DOJ) is filing FCA cases on its own at an unprecedented pace, suggesting recoveries will rise.  Be careful with what you put in the market because the requirements being imposed on companies are very real and you need to pay attention because you don’t want to get snared in an investigation.  Post Covid, FDA is going to be very vigilant with communications to consumers.  New areas of regulatory focus include company reliance on medical personnel to communicate with HCPs and the role of “product endorsers.” These will become bases of investigation and liability. 

Watch Out with Scientific Exchange and Interactions Between Medical and Commercial

Companies are permitted to discuss scientific data regarding a drug or device before it has been approved as long as that information is objective, fairly balanced, and includes any balancing risk information from the study or studies being described.  However, at no point until FDA approval may the company claim that the drug or device is safe and effective. There is a high internal concern and debate on what sort of structure an organization should have for commercial marketing and medical affairs.   If you have a medical scientific liaison (MSL) that calls on the doctor once and month and the salesperson does too, how do you differentiate what is promotional versus scientific exchange?  

Not Every Communication is Right for Social Media

There are basic FDA requirements that apply to all promotional materials, regardless of how the information is conveyed.  Among the most important principles are: 

  • Promotional materials must provide all material facts about the product to enable the physician to prescribe – and the patient to use – drugs and medical devices safely and effectively

  • Information must be "fairly balanced." This means there must be a balanced presentation of both the benefits and the risks

  • Product information cannot be false or misleading.  This generally means that the information is in the labeling.  Unsupported claims would be regarded as false and misleading

  • Net impression of the piece must create an accurate impression of the product and its appropriate uses

  • Prescribing information for drugs must be readily available so that the audience can see or easily obtain all relevant information about the product

Bottom line:  It’s the message not the medium and some platforms are simply not appropriate when you cannot communicate fair balance.  If the social media platform’s character limitations preclude including necessary information, FDA has said that it is not an appropriate platform.

Everyone Is Watching With Their Own Agenda

It’s not just government agencies who are watching for violative communications.  Healthcare professionals are also reporting concerns to the FDA through the Bad Ad Program which is an outreach program designed to help healthcare providers recognize potentially false or misleading prescription drug promotion.  Then there are competitors looking for an edge.  And don’t forget personal injury lawyers.  Here are a few tips:

  • Ensure effective monitoring procedures are in place for early signs of inappropriate conduct by any in-house function

  • Prioritize review of enforcement letters and CIA provisions to identify new areas of government interest

  • Know the regulations and have a solid base of knowledge for what is considered misleading

  • When promoting, always include adequate directions for use/do not misbrand (off label promotion)

  • Have your guardrails in place like SOPs

  • Look at technology to balance business and compliance objectives

 

Ilyssa Levins