Say Goodbye to FDA Complacency

Too many people think the Food and Drug Administration (FDA) favors predictability over speed. Think again.

While reading FDA tea leaves is a favorite policy and regulatory pastime, Commissioner Dr. Scott Gottlieb is generally one step ahead of industry futurists. In taking the helm at FDA, he outlined ambitious plans to tackle pressing public health and medical innovation issues drawing on his own journey as physician, government senior staffer, private-equity investor, drug development consultant, and cancer-patient survivor. Dr. Gottlieb knows that time is not always a patient’s friend.

From rare disease, gene therapy, and biosimilar approvals, to food and supplement safety, drug compounding, clinical trial requirements, and digital health tools, the new Commissioner’s agenda indicates he will not sacrifice predictably for speed, but rather, will use policy mandates to reduce confusion and accelerate everything from drug approvals to access. As he remarked at his swearing-in ceremony, “Patient and consumer protection are at the heart of what we do. And I believe deeply in that fundamental mission of this agency.”

Medtech and biopharma communicators are wise to find common ground with his agenda. Three tips to consider in aligning to the new Commissioner’s approach and working faster to help patients include:

  1. Be transparent and make it easy for patients: Clever is out—transparency is in. Dr. Gottlieb knows Beltway policy and pharma thinking. Imagine your PR plan left accidently on the Acela to D.C. Dr. Gottlieb sits in your still-warm seat and sees your forgotten PowerPoint. Will he be inspired? Will you be embarrassed? Think through how your information reaches consumers step-by-step from hand-off advocacy alliances to easy-reach mobile to demonstrate commitment to patient access.
  2. Foster health-ecosystem harmony: Dr. Gottlieb worked in varied health sectors—policy, patient advocacy, payer, provider, and product innovation. He seeks collaboration among sectors. Do your ideas work toward improving patient well-being? Will your plan pit one sector against the other to benefit your company alone? If so, watch out—Dr. Gottlieb’s policies target corporate behaviors that delay access to cost-effective care.
  3. Support the connected patient: Patients were once wired—tethered—to medical devices. Now they are wireless. Medtech apps, wearables, and artificial intelligence are no longer competitors—they complement patient-engagement plans. Dr. Gottlieb values digital health and social media. He is a patient advocate using his role to address how health/tech can improve care and reduce costs now. Are you doing your part?

PR and brand marketers will do well to read the Commissioner’s speeches and follow his official Twitter handle (@SGottliebFDA) to see where he’s going. Unlike many of his predecessors, Dr. Gottlieb signals plans and policies on social media daily. The Commissioner is an advocate for improved patient care. If he’s taking a cautious FDA into the future, health sectors that have been resistant to change can see his actions as a call to be bolder.

  • Nicole Cottrill

    Nicole Cottrill is Partner, Health at DVL Seigenthaler, a Finn Partners Company. Nicole Cottrill is a noted expert in provider, payer, and life sciences communications.


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