Final Summary FDA Liaison Meeting: November 18, 2020

The following is a final summary of the PPTA-FDA Liaison Meeting held virtually on November 18, 2020.  

Welcome, Introductions & Meeting Guidelines

PPTA’s Senior Director, Advocacy and Regulatory Policy, opened the meeting with introductory remarks.  PPTA Chief Legal Officer and Vice President, Global Initiatives, advised the participants on the meeting guidelines. 

Current Priorities

PPTA’s current priorities were presented to FDA. The priorities included Donor Health Projects, COVID-19 Response, Patient Access Concerns, Donor History Questionnaire (DHQ) Updates, CLIA Waiver for digital refractometer, and Changes to Donation Testing. PPTA requested an additional meeting to discuss donation testing based on recent communications between OBRR reviewers and member companies regarding RTTI testing of units deemed unsuitable for release. FDA stated to contact the Office of Communication to request a meeting. With respect to the advice letters’ language, FDA stated that they will continue review of current submissions and this issue will not hold up approvals.  The FDA also stated that it understands that the frequency of donation and the testing turnaround times mean that donations will occur before testing of previous donations is done.  FDA has no intention of changing that.

FDA shared their initiatives with PPTA. The initiatives include continuing to support the COVID-19 pandemic as it pertains to the plasma industry by encouraging both Source Plasma (SP) and convalescent COVID-19 plasma donations and supporting the industry with desk inspections and team-based reviews. Additionally, they reminded that guidances were released that are designed to allow for increased availability of plasma and blood.

Risk-based Revision of Current Policies to Ensure Continued Plasma-derived Therapies Availability

PPTA provided a presentation on risk-based revisions to current policies due to robust virus inactivation and removal of viruses from plasma products. The presentation focused on policies in specific areas:

Inventory hold — FDA will make a determination of whether to extend this waiver beyond the public health emergency.  In order to facilitate their review, they requested information on how a reduction in the inventory hold would affect the safety and supply of SP.

Syphilis Test Requirements — FDA requested PPTA members provide rates of syphilis positive tests in donors to help their internal conversations and thanked PPTA for raising the issue again.

Global Harmonization — FDA responded that they are very much engaged on a global scale by participating in various international bodies including the Blood Regulators Network.

HIV vs Hepatitis Risk Timeframes — FDA responded that they are reviewing and considering the comments to the 2020 HIV Guidance document, although there is no expected completion date at this time.

PPTA reiterated the wish to explore these and other issues related to behavioral risk deferrals in more depth at a workshop. This was an outcome of the 2019 liaison meeting but has been disrupted due to the global pandemic response. When feasible, PPTA is still most interested and FDA agreed.

PrEP and ARV – AABB’s Association Bulletin Recommendations and Applicability to our Industry/FDA’s Current Considerations

PPTA provided a presentation on how plasma donations differ from blood donations, due to the pathogen reduction measures in manufacturing of plasma-derived therapies. Due to this, PPTA does not believe that it is necessary to add PrEP and ARV to the DHQ as AABB has recommended for its members. AABB’s recommendation is a three-pronged approach of donor education, addition to the medication list and specific questions added to the questionnaire.  PPTA asked FDA to consider the differences between plasma for manufacturing use and blood for transfusion if it is considering policy in this area.

FDA responded that in the blood community, HIV infected donors (i.e. those with a known HIV infection) have been donating blood. AABB added PrEP and ARV measures to the DHQ process to prevent them from donating. FDA asked if this was an issue with SP donors. PPTA responded that a study similar to Custer’s study has not been done with SP donors, but with all the industry’s safety procedures in place, the final product would not be affected. FDA advised that it will take into account the conditions that are different for the plasma industry in its consideration of whether to adopt the AABB’s approach.

Donation Suitability Requirements Under 21 CFR 630.30

As a follow up to the 2019 PPTA/FDA Liaison Meeting, PPTA discussed the donor suitability requirements under 21 CFR 630.30. PPTA submitted letters and a legal opinion on enforcement of 21 CFR 630.30 to FDA in January and June 2020.  In the latter, PPTA offered solutions to allow plasma to be used from donors found to be ineligible after donation but also offered enforcement options for “bad actors”.

FDA responded that they have received industry’s letters and they are currently under review. They reminded that the April Alternative Procedures guidance does permit release of plasma if, after a donation, a donor is found to be outside the limits for blood pressure, pulse, weight or frequency of donation. If industry had any follow up questions, FDA encouraged them to reach out to Nicole Verdun or Jennifer Scharpf.

Donor Health Update

PPTA provided a presentation on updates to the donor health initiatives, including the Donor Adverse Event (DAE) Analysis, Donor Health Study and Lapsed Donor Study and discussed futures studies, including a biennial DAE analysis and Short-Term Health Effects After Plasma Donation.

FDA responded by stating that they are looking forward to the publications.

FDA’s New Work Process in CBER/OBRR Blood and Plasma Branch (BPB)

PPTA provided a presentation with feedback on the how FDA’s new initiatives in BPB for the management of regulatory applications and communications from blood establishments. PPTA stated that the overall process is working well, but there were significant issues with communication from FDA to industry throughout the process to completion.

During the PPTA Liaison meeting, it was stated that some inquiries sent to the CBEROBRRBPBInquirries@fda.hhs.gov email address were not answered. FDA asked that the those unanswered should be emailed to Dr. Verdun at Nicole.Verdun@fda.hhs.gov.

FDA responded that they take all concerns seriously but do not have the direct answers at this time. They will review internally and will get back to PPTA.

Awareness Campaign

PPTA provided a presentation on the PPTA’s communications initiatives in response to declining plasma donations during the COVID-19 pandemic. PPTA encouraged FDA for “plasma” to be added to the CURES Act language passed earlier this year that directs HHS to initiate a blood awareness campaign.

FDA responded that they were appreciative of the presentation.

Closing Remarks

PPTA emphasized that the industry’s main purpose has not changed during the COVID-19 pandemic. Patients with rare diseases who are treated with plasma derived therapeutics had their disease prior to the pandemic and will continue to have disease after the pandemic. Industry has serious concerns that the pandemic-related decline in plasma collections could have a significant, negative impact on future patient access to plasma protein therapies.

PPTA is thankful to the FDA for decision making that is rooted in science and for FDA’s willingness to continue to have this liaison meeting. PPTA values FDA’s partnership more than ever.

 

Participants

PPTA Members

Cyndi Tolman, ADMA BioCenters
Kaitlin Kesterberg, ADMA Biologics, Inc
Alina Frantescu, Biotest
Jennifer Duven, BPL Plasma
Mary Ann Lamb, BPL
Laura O’Brien, CSL Behring
Toby Simon, Plasma and Plasma Safety, CSL Plasma
Eva Quinley, CSL Plasma
Allison Kennedy, Emergent BioSolutions
Jay Bae, GCAM, Inc.
Tiffany Ramsey, GCAM, Inc.
Charles Auger, Grifols, Inc.
Marilyn Rosa-Bray, Grifols. Inc.
Kelly Smith, Grifols, Inc.
Janis Wilson, Grifols, Inc.
Michael Messick, ImmunoTek
Nelli Cherny, KEDPlasma
Michele Battle, Octapharma Plasma
Monica Byrd, Octapharma Plasma
Karen Clifford, ProMetic Plasma Resources Inc.
Ron Kraiss, The Interstate Bloodbank, Inc.
Julio Padilla Gil, Scantibodies Laboratory
Chuck Borders, Takeda
Roger Brinser, Takeda
Thomas R. Kreil, Takeda
Barbara Glantschnig, Takeda

FDA

Peter Marks, MD, PhD, Center for Biologics Evaluation and Research (CBER) Director
Celia Witten, MD, PhD, CBER Deputy Director
Diane Maloney, JD, Associate Director for Policy, Office of the Director, CBER
Julie Tierney, JD, Chief of Staff, CBER   
Nicole Verdun, MD, Director, Office of Blood Research and Review (OBRR), CBER
Anne Eder, MD, PhD, Deputy Director, OBRR
Jennifer Scharpf, MPH, Associate Director for Policy and Communications, CBER
Hira Nakhasi, PhD, Director, Division of Emerging & Transfusion Transmitted Diseases (DETTD), OBRR
Orieji Illoh, MD, Director, Division of Blood Components and Devices (DBCD), OBRR
Wendy Paul, MD, Deputy Director, DBCD
Carlos Villa, MD, Medical Officer, DBCD
Emily Storch, MD, Medical Officer, DBCD
Richard McBride, Chief, Blood and Plasma Branch (BPB), DBCD
Camilla Smith, Consumer Safety Officer, DBCD, BPB
Basil Golding, MD, Director, Division of Plasma Protein Therapeutics (DPPT), Office of Tissues and Advanced Therapies (OTAT), CBER
Mahmood Farshid, MD, Deputy Director, DPPT
Dorothy Scott, MD, Chief, Plasma Derivatives Branch (PBD), OTAT   
Jeffrey Anderson, Branch Chief, Manufacturers Assistance & Technical Training Branch (MATTB), Office of Communications, Outreach and Development (OCOD), CBER
Pauline Cottrell, Consumer Safety Officer, Manufacturers Assistance & Technical Training Branch (MATTB)
Susan Rogerson, Division of Inspections and Surveillance/Acting Program Surveillance Branch Chief, Office of Compliance and Biologics Quality (OCBQ), CBER

PPTA Staff

Amy Efantis, President & CEO
Josh Penrod, Senior Vice President, Source & International Affairs
Mary Gustafson, Vice President, Global Regulatory Policy
John Delacourt, Chief Legal Officer and Vice President, Global Initiatives
Dominika Misztela, Senior Director, Regulatory Policy Europe
Bill Speir, Senior Director, Advocacy and Regulatory Policy
Larisa Cervenakova, Medical Director
Sonia Balboni, Director, Source & Standards
Mat Gulick, Director, Global Communications
George Schreiber, Director, Epidemiology
Michelle Fransen, Project Manager, Health Initiatives
Michelle Mason, Coordinator, Regulatory Policy

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