AbbVie
BusinessSupport
Benefits of pfdd meetings
Patient-centered research and advocacy
Impacts of Patient-Focused Drug Development Meetings; Establishment of a Public Docket; Request for Information and Comments
FDA-2026-N-3947-0001RFI
Comments
69
Last activity Jun 30, 2026
Deadline
Closed on Jul 1, 2026
Closed Jul 1, 2026
Net supportiSupport minus oppose · campaigns included
+80%
+80% excluding campaigns
Document
Details
The document's own metadata, straight from the source system.
- Title
- Impacts of Patient-Focused Drug Development Meetings; Establishment of a Public Docket; Request for Information and Comments
- Posted
- May 1, 2026
- Comment period
- May 1, 2026 – Jul 1, 2026
- FR Doc
- 2026-08524
- Topics
Analysis
Overview
What the public is saying — stance, who's commenting, and the issues they raise.
Include campaigns
Stance breakdown
+80%
Net support
Support61Oppose6Other2
Aggregates include form-letter campaigns. Excluding them, net support is +80% across organic comments.
Who commented
Breakdown by commenter type.
Academic
1
Business
9
Individual
14
Trade association
2
Advocacy
43
Comments over time
Weekly arrivals, stacked by stance.
Posted May 1, 2026Deadline Jul 1, 2026
Apr 27May 25Jun 8Jun 22Jun 29
Support61Oppose6Other2
Support × commenter type
How each type splits across stance.
Support
Oppose
Other
Advocacy
100%
0%
0%
Individual
50%
43%
7%
Business
100%
0%
0%
Trade association
100%
0%
0%
Academic
0%
0%
100%
Issues raised
The docket's canonical issues. Select one to browse its comments.
Benefits of pfdd meetings53
Lifecycle of patient engagement52
Patient-centered research and advocacy52
Bias in drug approval decisions3
Impact of public activism2
Industry influence on patient advocacy2
Standardizing externally-led pfdd meetings2
Transparency and conflict-of-interest safeguards2
Inappropriate advocacy communication1
Scientific integrity in drug approval1
Position map
Who stands where on each issue?
Every non-silent position is backed by an excerpt from the comment.
Issues shown
Choose up to five.
| Organization | Benefits of pfdd meetings | Patient-centered research and advocacy | Lifecycle of patient engagement |
|---|---|---|---|
AbbVie BusinessSupport AbbVie supports the FDA's request for information regarding the impacts of Patient-Focused Drug Development (PFDD) meeti | · | ||
Alexion Pharmaceuticals BusinessSupport Alexion Pharmaceuticals, a division of AstraZeneca focused on rare diseases, supports the use of Patient-Focused Drug De | · | ||
Arthritis Foundation AdvocacySupport The Arthritis Foundation supports the FDA's Request for Information on Patient-Focused Drug Development (PFDD) meetings, | |||
Biotechnology Innovation Organization (BIO) Trade associationSupport The Biotechnology Innovation Organization (BIO) supports the FDA's initiative regarding Patient-Focused Drug Development | · | ||
Canary Advisors BusinessSupport Canary Advisors supports the initiative to establish a public docket and requests that the FDA create a consistent, tran | |||
Critical Path Institute AdvocacySupport The Critical Path Institute (C-Path), a nonprofit organization, supports the FDA's initiative on patient-focused drug de | · | · | |
CurePSP AdvocacySupport CurePSP, a non-profit organization for atypical parkinsonian diseases, supports the Patient-Focused Drug Development (PF | |||
Faegre Drinker Consulting BusinessSupport Faegre Drinker Consulting, a consulting firm that assists patient advocacy organizations, supports the FDA's Patient-Foc | |||
Foundation for Angelman Syndrome Therapeutics (FAST) and the Angelman Syndrome Foundation (ASF) AdvocacySupport The Foundation for Angelman Syndrome Therapeutics (FAST) and the Angelman Syndrome Foundation (ASF) support the FDA's in | · | ||
Hepatitis B Foundation AdvocacySupport The Hepatitis B Foundation supports the FDA's patient-focused drug development (PFDD) program, highlighting how it has t | · | ||
Huntington's Disease Society of America AdvocacySupport The Huntington's Disease Society of America (HDSA) supports the FDA's Patient-Focused Drug Development (PFDD) meetings a | |||
International Pemphigus and Pemphigoid Foundation (IPPF) AdvocacySupport The International Pemphigus and Pemphigoid Foundation (IPPF) supports the proposed action by highlighting the positive i | |||
Lupus and Allied Diseases Association, Inc. AdvocacySupport The Lupus and Allied Diseases Association, Inc. | · | ||
Lupus Foundation of America AdvocacySupport The Lupus Foundation of America supports the FDA's initiative to document the impacts of Patient-Focused Drug Developmen | |||
Muscular Dystrophy Association AdvocacySupport The Muscular Dystrophy Association (MDA) expresses strong support for the FDA's Patient-Focused Drug Development (PFDD) | |||
National Eczema Association AdvocacySupport The National Eczema Association (NEA) supports the FDA's request for information on Patient-Focused Drug Development (PF | · | · | |
National Health Council (NHC) AdvocacySupport The National Health Council (NHC) supports the FDA's request for information on the impacts of Patient-Focused Drug Deve | · | ||
National Organization for Rare Disorders (NORD) AdvocacySupport The National Organization for Rare Disorders (NORD) supports the Patient-Focused Drug Development (PFDD) program and adv | |||
UCB, Inc. BusinessSupport UCB, Inc., a global biopharmaceutical company, supports the FDA's efforts to incorporate patient voices into drug develo | · | · | |
United Liver: Leaders In Liver AdvocacySupport United Liver, an international nonprofit consortium representing patients with liver diseases, supports the Patient-Focu |
Alexion Pharmaceuticals
BusinessSupport
Benefits of pfdd meetings
Lifecycle of patient engagement
Arthritis Foundation
AdvocacySupport
Benefits of pfdd meetings
Patient-centered research and advocacy
Lifecycle of patient engagement
Biotechnology Innovation Organization (BIO)
Trade associationSupport
Benefits of pfdd meetings
Patient-centered research and advocacy
Canary Advisors
BusinessSupport
Benefits of pfdd meetings
Patient-centered research and advocacy
Lifecycle of patient engagement
Critical Path Institute
AdvocacySupport
Benefits of pfdd meetings
CurePSP
AdvocacySupport
Benefits of pfdd meetings
Patient-centered research and advocacy
Lifecycle of patient engagement
Faegre Drinker Consulting
BusinessSupport
Benefits of pfdd meetings
Patient-centered research and advocacy
Lifecycle of patient engagement
Foundation for Angelman Syndrome Therapeutics (FAST) and the Angelman Syndrome Foundation (ASF)
AdvocacySupport
Benefits of pfdd meetings
Patient-centered research and advocacy
Hepatitis B Foundation
AdvocacySupport
Benefits of pfdd meetings
Lifecycle of patient engagement
Huntington's Disease Society of America
AdvocacySupport
Benefits of pfdd meetings
Patient-centered research and advocacy
Lifecycle of patient engagement
International Pemphigus and Pemphigoid Foundation (IPPF)
AdvocacySupport
Benefits of pfdd meetings
Patient-centered research and advocacy
Lifecycle of patient engagement
Lupus and Allied Diseases Association, Inc.
AdvocacySupport
Benefits of pfdd meetings
Lifecycle of patient engagement
Lupus Foundation of America
AdvocacySupport
Benefits of pfdd meetings
Patient-centered research and advocacy
Lifecycle of patient engagement
Muscular Dystrophy Association
AdvocacySupport
Benefits of pfdd meetings
Patient-centered research and advocacy
Lifecycle of patient engagement
National Eczema Association
AdvocacySupport
Patient-centered research and advocacy
National Health Council (NHC)
AdvocacySupport
Benefits of pfdd meetings
Lifecycle of patient engagement
National Organization for Rare Disorders (NORD)
AdvocacySupport
Benefits of pfdd meetings
Patient-centered research and advocacy
Lifecycle of patient engagement
UCB, Inc.
BusinessSupport
Patient-centered research and advocacy
United Liver: Leaders In Liver
AdvocacySupport
Benefits of pfdd meetings
Patient-centered research and advocacy
Lifecycle of patient engagement
1 organization-typed comment could not be identified.
Comments
Explorer
Every mirrored comment — filter by stance, campaign, or issue.
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- May 6, 2026Comment from Bower, KaylinSupportIndividual📎 Attachment
The commenter argues that the FDA should not allow patient advocacy groups to pressure the agency into approving drugs that do not meet statutory scientific requirements. They specifically cite the approval of Exondys as a negative precedent and call for the FDA to take a firm stance against "bullying" and "intimidation" by advocacy communities during the drug development process.
Read comment → - May 6, 2026Comment from Bower, KaylinOpposeIndividual
The commenter expresses concern that patient-focused drug development can lead to bias and undue pressure within the FDA's review process. They cite a memo highlighting how private conversations with stakeholders can undermine the integrity and trust of the drug approval team.
Read comment → - May 5, 2026Comment from Bower, KaylinOpposeIndividual
The commenter, who appears to be a private individual, expresses strong opposition to the FDA's patient-focused drug development (PFDD) program. They argue that the program allows patient advocacy and political pressure to influence drug approvals, potentially leading the FDA to disregard statutory requirements for New Drug Applications (NDAs).
Read comment →