FDA Advisory Committee Meeting Open Public Hearings: 5 Tips for Planning a Critical Hour on a Critical Day

An Open Public Hearing at an FDA Advisory Committee meeting is specifically designed to allow patients, physicians, and other interested stakeholders to speak about the medical condition being discussed, and whether they are in favor of the drug or device before the committee for approval.For a full-day Advisory Committee meeting, FDA has mandated that 30-60 minutes be set-aside for an Open Public Hearing. Given that a sponsor’s presentation is often that same amount of time, the Open Public Hearing is a significant portion of the day. And for many Advisory Committee members, what these speakers say really counts.  In fact, in a recent poll conducted by 3D Communications of former and current and Advisory Committee members, 81% of those surveyed said that testimony in the Open Public Hearing to some degree can influence their decision on the day of the Advisory Committee meeting.  Yet, many pharmaceutical and device companies overlook this valuable opportunity when preparing for their Advisory Committee meetings.

We at 3D Communications have more than 20 years of experience helping companies prepare for FDA Advisory Committee meetings. As part of that preparation, we consider the Open Public Hearing and stakeholder relations to be a critical part of a critical day.  Here are five tips we follow to maximize the Open Public Hearing and build overall stakeholder relations.

1.   Foster Relations with Stakeholders: An Advisory Committee meeting and its Open Public Hearing provide an ideal opportunity to sustain and deepen relations with clinical trial investigators and advisory board members who have guided and supported a drug or device’s development.  It also provides a platform for scientific exchange with professional societies and patient advocates who may have questions from their communities on the pivotal data.  Companies should take advantage of these opportunities and, while aligning with internal company policies, build them into their plans for outreach with all appropriate stakeholders.

2.   Inform and Support, but Don’t Interfere:  Companies who inform stakeholders of the opportunity to speak at an Open Public Hearing are only sharing publicly available information.  Every meeting’s notice will be posted to the government’s Federal Register notice and FDA’s website. A stakeholder’s testimony must be told in his or her own words, without interference from the sponsor.  While companies should not pay speakers for their time preparing for or attending the Open Public Hearing, they can support travel-related expenses for the meeting.  However, the speaker must disclose the support at the beginning of his or her testimony, and the company must disclose the support to adhere to rules set by the Physician Payments Sunshine Act.

3.   Let the “Quality of Life” Story Tell Itself:  A large part of the committee’s benefit/risk determination is assessing the impact of the condition, the current standard-of-care, and the potential new product on day-to-day quality of life measures. In fact, 58% of current and former Advisory Committee members surveyed by 3D Communications noted that comments in the Open Public Hearing were important in helping them to understand and comment on the product or issue being discussed. When statistics and data fall short, we tell clients that it is often best to let the quality of life story tell itself through the voices of patients and caregivers.  They’re in the best position to paint the clearest picture of the impact on finances, career, family and daily life tasks.

4.   Advocate the Sharing of Data by Investigators, Physicians, and Medical Societies in Real-World Context:  Although they are experts, all Advisory Committee members may not come to the table with the same amount of experience in a clinical condition and its current standard-of-care. Through investigator and specialist testimony, data can be framed in a real-world context as these experts share with the committee what they know and see from a clinical perspective.  If a drug or device is approved outside of the U.S. and has demonstrated long-term safety and effectiveness, testimony from ex-U.S. clinicians who have used the product on patients may address committee members’ concerns on how the product would be used if approved.  Support for the travel of these ex-U.S. experts would also need to be disclosed in each stakeholder’s testimony and follow internal policies of disclosure under the Physician Payments Sunshine Act.

5.   Be Prepared to Address Criticism and Questions: As companies prepare for their Advisory Committee meeting’s Question and Answer (Q&A) session, they should also be prepared for criticism and questions that may occur during the Open Public Hearing. As it is a public meeting, anyone, including critics, can speak at the Open Public Hearing.  Although it does not happen often, committee members may ask speakers questions about their testimony and experience. If a company has thoroughly prepared for their meeting’s Q&A session, however, there should be no criticism or question that comes as a surprise or cannot be addressed by the company after the Open Public Hearing.

Open Public Hearings have been a mandated part of FDA Advisory Committees for nearly 50 years, but given FDA’s goal of incorporating the patient perspective into drug approvals under its Patient-Focused Drug Development initiative, the Open Public Hearing has never been more important than it is today. By following these best practices when planning for the Open Public Hearing and adhering to both internal and FDA policies and procedures, a company can strengthen their Advisory Committee meeting’s overall strategy and build relations with valued stakeholders.


 

ABOUT THE AUTHOR

Eileen Crowley brings more than 15 years of experience as a communications and advocacy specialist to clients in the pharmaceutical, medical device, and public health arenas. Eileen works with 3D clients to engage with professional and patient groups and to leverage that support throughout the product lifecycle, including FDA consulting on Advisory Committee meetings, Market Access Communications and grassroots disease education programs. Connect with Eileen on LinkedIn.