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Your ULTIMATE Guide to the FDA Public Hearing on “Draft Guidances” Regulating Cells and Tissues (Part 15)

Cade Hildreth (CEO)
FDA Public Hearing on Stem Cells Postponed - Rescheduled Hearing to be Landmark Event

Nearly everyone in the stem cell community knows that there was supposed to be a FDA public hearing on April 13, 2016, related to four draft guidances controlling the regulation of stem cells.

Officially called a public hearing on “Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products Part 15,” the event was to be held at the FDA White Oak Campus located at 10903 New Hampshire Ave., Bldg. 31, Rm 1503 (Great Room), Silver Spring, MD, 20993.

To enroll for the event, you had to email “CBERPublicEvents@fda.hhs.gov” with your request to attend, contact information, and whether or not you wished to be a presenter. Whether it was intentional or not, very little time was given for the registration, which ended on on Jan. 8th, 2016, more than three months before the event was scheduled.

While the FDA originally blocked nine hours for the April 13, 2016, from 8:00 am-5:00 pm, we are now at a point in history where the regulatory treatment of stem cells could substantially alter both future innovation and patient access to emerging regenerative treatments.

Consequently, the public hearing attracted a massively large volume of attention.

In particular, groups like the Alliance for the Advancement of Cellular Therapies and PatientForStemCells.org urged everyone – including patients, clinicians, and professionals – to register for the hearing so that their input pertaining to the four draft guidances could be heard. (When Patients for Stem Cells (PFSC) posted about the event here, the article got more than 500 shares on Facebook alone, plus

Clearly, many people across the United States are substantially concerned about the draft guidances that appear to be a further restriction on stem cell therapy within the U.S.

Massive Turn-Out Produces Delays

By the time that the brief registration period ended, there were approximately 600 registrations sent to FDA and  100 people/groups asked to present. I was one of the 600 registrations, and I personally know dozen of others from the stem cell community who registered, including many who were flying in from out-of-state in order to voice opinions and concerns.

BioInformant has offices in Washington, DC, for exactly this reason, to have proximity to the FDA, NIH, and importantly, to our government representatives on Capital Hill.

We had our whole team prepared to attend the event and had special t-shirts printed to wear. (You can get them too.)

As a result of the large number of presenter requests, the FDA allocated each person only three (3) minutes to speak. Also, there was no time buffered for speaker transitions, so in practicality, each presenter would only get about 90-120 seconds of usable time.

This time limitation was placed on everyone, including groups like the Centeno-Schultz Clinic that pioneered the groundbreaking Regenexx® procedure, a stem cell-based approach that has transformed orthopedic options within the United States.  (You can see my recent  interview with Dr. Chris Centeno, the visionary behind the Regenexx® technology, at this link.)

While a nine-hour period was blocked from 8am-5pm, the FDA included in that time an hour-long lunch break (12-1pm) and two half hour breaks (9:55-10:25am and 3:00-3:30pm), reducing the usable time to only seven hours.

Importantly, for groups that had multiple registrations, attendees were lumped together and given a six (6) minute slot for whoever was designated the group representative.

This time limitation was again placed on everyone, including massive organizations operating within the cell therapy sector, such as the Foundation for the Accreditation of Cellular Therapy (FACT), International Society for Cellular Therapy (ISCT), and Alliance for the Advancement of Cellular Therapies (AACT).

In general, it is my opinion – and one that is shared by most advocacy groups – that the large turn-out for the event was a successful effort to communicate patient concerns to the FDA and a way to indicate that more input is needed in the regulatory process.

Original Draft Schedule for Public Hearing

Courtesy of the Alliance for the Advancement of Cellular Therapies, here is a full list of speakers who were originally scheduled to present at the April 13, 2016, FDA public hearing on “Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products Part 15.”

Presenters Allocated 3 Minutes Each
Groups Allocated 6 Minutes Each

After this preliminary draft scheduled became available, the Alliance for the Advancement of Cellular Therapies sent a request to the director of CBER requesting a delay for the meeting and to request for scientific exchange in a workshop setting. Others also provided that FDA with similar requests.

Postponement Notice Issued for FDA Public Hearing

Due to the overwhelming response to the public heading, the FDA issued an electronic postponement letter on February 29, 2016, that read:

Dear Registrants,

There has been considerable interest in the Public Hearing, “Request for Comments – Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products,” scheduled to take place on April 13, 2016.  Due to this interest, and to give stakeholders additional time to provide comments to the agency, FDA intends to extend the comment period for the draft guidance documents, and has postponed the hearing, which will be rescheduled later this year at a date to be determined.  The agency also intends to schedule a scientific workshop to gather information from manufacturers of cell based products, clinical researchers, and other stakeholders regarding the generation of scientific evidence to facilitate the development of safe and effective cell based therapeutics.

Information on the rescheduled hearing, including date, location and registration information, will be made available on FDA’s website and will be published in the Federal Register.  We will announce the dates for the hearing and the workshop in the near future.

FDA’s announcement will contain information on how stakeholders interested in speaking, including those who were scheduled to speak at the hearing on April 13th, can sign up to speak at the rescheduled hearing.

Thank you,

Food and Drug Administration
Center for Biologics Evaluation and Research

You can also see the postponement announcement on the FDA site here.

Rescheduled Part 15 Public Hearing on Regulation of Cells and Tissues

More recently, the FDA announced that the public hearing to review the “Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products Part 15″ was rescheduled for September 12-13, 2016, a five-month delay.

Two-day format is a substantial improvement over the original one-day format that would had allotted each speaker and presenting group only 3 minutes of time. The larger venue size is also an improvement, as the FDA designated an auditorium this time around.

The new hearing will be held at Masur Auditorium on the campus of the National Institutes of Health, in Bethesda, Maryland.

See the image below to identify access points to the event within the Warren Grant Magnuson Clinical Center, which is contiguous with the Mark O. Hatfield Clinical Research Center:

Map of Masur Auditorium at NIH Campus in Bethesda, MD

To learn more about the event or register to attend, view the FDA page here:

“Public Hearing; Request for Comments – Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products”

Unfortunately, people (including FDA employees) who wanted to attend or speak at the public hearing had to register by June 1, 2016 and “sales” for the event have also ended.

If you did register in time, you should have received a ticket confirmation that looks like this:

However, the FDA will make a link to an Event Webcast available at the link above, so mark your calendars for September 12-13, 2016, and plan to tune in. 

It is important that stakeholders from across the stem cell community participate in this crucial event.

About BioInformant

BioInformant is the only research firm that has served the stem cell sector since it emerged. BioInformant research has been cited by major news outlets that include the Wall Street Journal, Nature Biotechnology, Medical Ethics, Vogue Magazine, and more. Serving Fortune 500 leaders that include GE Healthcare, Pfizer, Goldman Sachs, and Becton Dickinson, BioInformant is your global leader in stem cell industry data.

 

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