FDA FOIA Monitor — May 2026
foiadocs.com · Inaugural Edition

FDA FOIA Monitor

Monthly Intelligence for FDA FOIA Practitioners

68,274 FDA FOIA Requests.
Here's What They Tell Us.

In this inaugural edition of FDA FOIA Monitor, we're setting the baseline against every future change. Volume trends, processing times, requester behavior, and document-type patterns — we've analyzed every closed FDA FOIA request from 2020 through May 2026 to establish this standard. Bookmark it. In future issues, we'll highlight notable deviations.

68,274 Total Requests (2020–May 2026)
+47% volume growth, 2020→2024
75.7% Full Release Rate
Of all closed requests; 1.4% formally denied
32 days Median Processing Time
Avg: 157 days (long tail of complex requests)
17,288 Unique Requesters
Individuals, firms, and orgs that have filed at least once
13,403 Peak Year: 2024
2026 YTD on pace to match (~13,000 projected)
15.3% Withdrawal Rate
Of closed requests — most due to fees or data found elsewhere

The Month in Numbers

Metric May 2026 May 2025 YoY
Requests Closed 856 851 +0.6%
Median Processing Time 55 days 45 days +22%
Release Rate 66% 76% −13%
Avg Processing Time 185 days 123 days +50%
Withdrawals 124 142 −13%
Formal Denials 0 9
Editor's Note The number to watch is the drop in Release Rate to 66%. The 2024–2025 average was 74%. May 2026 had zero formal denials, which is unusual but doesn't explain the gap. Instead, request withdrawals and "no records found" outcomes account for more of the total. Watch for June!

Processing Times Are Rising. Fast.

Median close times climbed steadily since 2024. The 2026 YTD median across all doc types now sits at — or above — levels last seen in 2022. Practitioners with time-sensitive needs should pay special attention to two categories...

483
31 days
+72% vs '24
ANDA
28 days
+75% vs '24
FAERS
20 days
+25% vs '24
EIR
38 days
↓ from '25
NDA
38 days
+81% vs '24
510(k)
205 days
stable
Correspond.
142 days
+318% vs '24
FSVP
106 days
from 14 days
PMTA
620 days
+179% vs '24

Bar length proportional to 2026 YTD median. Green = fastest track. Red = significant delay.

Practitioner Takeaway If you have a time-sensitive 483 or ANDA request, file now. Those are still the fastest tracks at ~28–31 days. Avoid correspondence requests unless you can wait: processing time rose 318% from 34 days (2024) to 142 days (2026 YTD) in this dataset's steepest degradation. (With a processing time of 620 days, PMTA essentially establishes its own category.)

Who Files FDA FOIA — and How They Do It

Of the 68,274 requests in the dataset, commercial FOIA services dominate volume with 25% of all filings. But the most striking trend stems from News / Media requests, which grew 190% from 2020 to 2025, and surged 169% in 2024 alone.

Category Total % of All Median Days Release Rate
Commercial FOIA Services
FDACzilla · Redica · FOI Services
16,958 24.8% 28 83.8%
Regulated Industry 11,871 17.4% 34 73.5%
Individual / Citizen 7,472 10.9% 34 66.9%
Law Firms 4,714 6.9% 50 68.0%
News / Media
Capitol Forum · Bloomberg · STAT · Daily Signal
4,541 6.6% 32 69.3%
Academic / Research 2,235 3.3% 29 73.5%
Government 51 0.1% 83 91.7%
Key Finding Government requesters (GAO, federal defenders, congressional offices, etc.) have the highest release rate in the dataset at 91.7%. They wait the longest (avg. 810 days) and file least, but when they ask, FDA releases. Bloomberg and Capitol Forum drove much of the News / Media request growth, reflecting increasing coverage of FDA enforcement, drug pricing, and manufacturing failures.

With 703 GLP-1 Requests, 2026 Set to Break Record.

GLP-1 FOIA requests have grown from 4 in 2020 to a pace that will exceed 2024's record by year's end. FAERS reports (217 requests), agency correspondence (98), and NDA review files (76) are the most-requested doc types in this category.

2020
4
2021
15
2022
15
2023
76
2024
297
2025
149
2026 YTD
147

2025 figure reflects requests closed in calendar year 2025. Many 2025-filed GLP-1 requests remain pending.

Notable: Bloomberg's 2024 request for GLP-1 drug communications with food and beverage companies (closed after 705 days with "No Records") signals investigative appetite for the supply chain and commercial angle. The Hunterbrook Media request on BLP Labs compounding-enforcement was released after 695 days.

Top 20 Most-Referenced Products, Companies & Topics

We drew these counts from the Title field of all 68,274 requests — the most complete signal in the dataset. Names are normalized (e.g. Novo Nordisk Inc. = Novo Nordisk) and variant spellings are merged. GLP-1 drugs are grouped by INN to capture all branded references.

1
358
2
Syfovre (pegcetacoplan)
330
4
196
6
163
7
Izervay (avacincaptad pegol)
145
8
134
9
132
10
128
11
124
12
123
13
118
16
99
17
92
18
75
19
75
What the rankings reveal The two GA drugs — Syfovre (#2, 330) and Izervay (#7, 145) — together account for more Title references than Eli Lilly and Novo Nordisk combined, driven by a single competitive-approval wave in 2023. Semaglutide (#3, 298) and tirzepatide (#14, 113) show GLP-1 as a sustained multi-year phenomenon, not a spike. Pfizer at #1 reflects broad activity across vaccines, generics, oncology, and manufacturing, with no single driver.

Watch List — Products With Significant FOIA Activity

Product / Term Category First FOIA Yr All Time 2024 2026 YTD
semaglutide GLP-1 2021 262 160
Syfovre Ophthalmology 2023 295 117
Catalent CMO / Enforcement 2020 290 39
Izervay Ophthalmology 2023 167 108
JUUL Tobacco / E-Cig 2020 99 13
Capricor Cell Therapy / Rare 2025 13 0
ivermectin Policy / COVID-era 2020 60 11
naloxone Opioid / OTC 2020 44 9

Product Tracker counts pull from the Title column across all records. Subscriber access includes the live spreadsheet with formula-based tracking.

Request Volume by Year

2020
9,117
2021
8,698
2022
8,942
2023
10,469
2024
13,403
2025
11,434
2026 YTD (May): 6,211 closed · On pace ~13,000

Three Things Heading Into June

1 — Correspondence Requests: The Slow Lane Median days for correspondence requests jumped from 34 (2024) to 142 days (2026 YTD). That's an increase of 318%. If you have pending correspondence requests filed in 2024, they're probably still waiting. If you're filing new ones, expect a minimum of 4–5 months.
2 — The Release Rate Slide May 2026 release rate was 66%, 8 points below the 2024–2025 average. This metric is a leading indicator of staff capacity and processing backlogs. If it falls below 60% in the June log, that's a meaningful signal about FDA FOIA Office throughput.
3 — GLP-1 Requests: The Record Is Coming With 147 GLP-1 requests closed through May 2026 (rivalling all of 2025), the full-year total is on pace to exceed 2024's record of 297. Watch for compounding-enforcement records, Zepbound label requests, and tirzepatide FAERS filings to drive Q3 volume.
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