The Seven Deadly Sins of Regulatory Communications

 By Dr. Laurie Smaldone 

For many companies, effective regulatory communications can be a cause for worry. It’s necessary for approval but, like the weather, seems largely out of your control.

Maybe you realize only too late that the agency wanted a different set of endpoints. Or maybe you see in hindsight that you needed different subgroups.

Bottom line, you end up making mistakes that lead to setbacks and delays that could’ve been avoided with a more open and proactive approach. We think of these as the Seven Deadly Sins of regulatory communications. What are they?

  • Talking too much/listening too little. You can’t hear what the FDA is saying if you’re delivering a monologue. Sometimes, companies feel they need to throw the kitchen sink at the agency and overwhelm them with data as a precaution. A better approach is to take a deep breath and really try to hear the agency’s advice.
  • Not understanding the whyA consequence of the first. If you listen too little and don’t put yourself in their shoes, you won’t understand the reasons behind the FDA’s advice.
  • Failure to establish a credible, transparent, collaborative relationship. The FDA is not your enemy. They share your goal of helping patients. Work with them.
  • Not being prepared for the unexpected. Positive or negative, regulatory communications is a game with curveballs. Through careful planning and active communication with the FDA, you give yourself a chance to make the adjustments that could lead to approval down the line.
  • Failure to explicitly ask the tough questions. Address them head on. Ask the hard questions on your own—early, openly, and honestly.
  • Arguing every issue. Instead, negotiate and pick your battles, knowing you can’t win ‘em all. Recognize what matters and focus on that.
  • Allowing differences in interpretation to persist. On your own team or in dialogue with FDA, you need to clarify ambiguities in the data or in agency guidance.

I’ll be talking more about these issues—and offering tips on how to avoid mistakes in regulatory communications—at BIO 2014 in San Diego on June 25. I’ll be joined by Dr. Eric Brass, Professor of Medicine, David Geffen School of Medicine at UCLA and Director, Harbor-UCLA Center for Clinical Pharmacology; Dr. Marianne Mann, Consultant and former Deputy Director, FDA Division of Pulmonary and Allergy Drug Products; and Dr. David Essayan, Executive Vice President, ONCORD, Inc. and former Supervisory Medical Officer, FDA.

We hope our session “Are You Really Hearing What the FDA is Saying? Lessons Learned in Regulatory Communications” will help people avoid some the major pitfalls of communicating with FDA. After all, regulatory communications excellence is central to success!

Regulatory Communications Made Accessible

By Dr. Laurie Smaldone

Every phase of drug development has its challenges and thrills. Most exciting for me is the moment when a company begins the conversation with regulators. Why? That conversation is a vital step on the journey toward commercialization, a moment when researchers must persuade an audience outside their company that a drug or device enhances public health. It’s a unique challenge. Scientific teams, long accustomed to research, must quickly turn their attention to communication to demonstrate how their data satisfies regulatory guidelines.

While communicating with regulators is certainly routine and required, in my experience, it is one of the more misunderstood aspects of product development and often a missed opportunity. For many, the regulatory approval process remains mysterious, a black box on the way to commercialization.

PharmApprove aims to make the world of regulatory communications a little more accessible through monthly blog posts that address its key challenges. One of those challenges, for example, is learning to see evidence through a regulator’s eyes, a mental gearshift vital to success. To help address such challenges, PharmApprove’s experts will offer advice that improves scientific communications skills, clarifies current regulatory issues, and provide tips about presenting scientific data persuasively.

Over the years, PharmApprove has developed expertise and tools to prepare teams for US Advisory Committee and CHMP hearings. We have since expanded our services to help scientific teams achieve success all along the development process and navigate the complexities at important regulatory milestones. These complexities range from deciding how to weigh conflicting advice from regulators to pressure testing phase 3 plans. At every stage our passion is to help scientists develop the confidence, clarity, and skills for successful regulatory interactions.

Together, PharmApprove professionals have hundreds of years of industry experience. Individually, they represent a variety of skills and specialties that range from statistical acumen to clinical disease area knowledge to coaching and scientific communications expertise. In my own career, for example, I’ve led the commercialization of drugs in a variety of disease areas from cancer to HIV/AIDS to metabolic disorders.

PharmApprove is an acknowledged leader in strategic, regulatory, and scientific communications, and in future posts, my colleagues and I will share our expertise and experience with you. Our hope is that these insights will help colleagues to stand in front of regulators with greater confidence. After all, we have the people, processes, and passion to help you win.

Dr. Laurie Smaldone is President and CSO of PharmApprove. She has 25 years of executive leadership experience in drug development and regulatory strategy across all major therapeutic areas and product technologies. She has guided global teams through over 100 US FDA and European EMA proceedings, including preparations for key FDA meetings, Advisory Committee hearings, and EU Scientific Advice and Oral Arguments. Dr. Smaldone is trained in medical oncology and received her MD degree at Yale University.