FDA’s Dr. Theresa Mullin Addresses BIO Patient and Health Advocacy Summit

BIOtech Now
Paige Decker

“So, Theresa, where did you grow up? Did you have any siblings?” asked Marc Boutin, CEO of the National Health Council.

The crowd laughs. Where was he going with this?

“North Jersey—I am number four of five kids in my family,” responded, Dr. Theresa Mullin with a smile. “And I have to add, being the fourth kid makes you very good at negotiating which has helped me a lot in this line of work,” she said in jest.

“Negotiation is key in getting things done,”  Mullin reasserted.

Thus began a Fireside Chat with Mullin, FDA’s Director of Strategic Programs, at the recent BIO Patient and Health Advocacy Summit. And with that insight, it became clear why Dr. Mullin served as the lead FDA negotiator for the Prescription Drug User Fee Act (PDUFA) reauthorization. And further, why the patient community should also be a part of the negotiation conversation now, more than ever.

Onstage, Mullin and Boutin discussed the necessity for “patient-focused drug development programs.”  What does that mean?

Mullin’s background is the force that drives her concise decision-making in crucial regulatory negotiations. Her childhood and family dynamic informs her professional career today and is an important component of her success. We learned of her innate desire “to make things better,” which motivates her continued service to the patient community. It allowed for clarity in how she chose the 20 patient groups to be represented within the PDUFA reauthorization.

In their one-on-one conversation, Dr. Mullin and Boutin expanded upon the pathway to “patient-focused drug development” by highlighting the need for active listening while generating a widespread, inclusive conversation. “Just, listen to us,” said Boutin when industry representatives asked how they can be more helpful. Dr. Mullin reiterated the sentiment by adding, “patients are frustrated—there’s a lot of work to be done, and it takes longer than people would like,” giving the audience a peek into the complexities of drug development.

In a rapidly changing healthcare landscape, Boutin advocated for active and shared communication in the drug development process. He emphasized that the patient community must identify the obstacles within the community, communicate those goals effectively, and promote the solutions. Mullin expressed the importance of translating personal stories into regulatory change which will help patients and their families for decades to come. And that can only be changed with patient involvement from the very beginning of the drug development process. Dr. Mullin added that by negotiating early on for “qualitative data collected in clinical trials from good representatives of the patient population,” will enable better “utilization management—down the road.”

Thus, in order to continue to overcome the broader obstacles that have restricted the patient community for many years, from this conversation, Dr. Theresa Mullin and Marc Boutin have identified two simple steps to take towards a greater solution: speak-up and negotiate.

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