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FDA FOIA Monitor

Volume 1, Issue 4 · August 2026

Why is the August issue published in September? FDA releases its monthly FOIA log several weeks after month-end. Each issue of FDA FOIA Monitor analyzes the most recent data available; this issue covers August 1 through August 31. New here? Start with the 2020–2026 Baseline Report for full historical context.

Five Things That Changed in August

  1. FDA closed 1,026 requests in August, up from July's 935, the second straight monthly increase and the most closings since March.
  2. Median processing time ticked up to 27.5 days, from July's 23. Still nowhere near the 44–58 day range that opened the year, but proof the recent run of teens-and-twenties readings wasn't fully locked in.
  3. Release rate recovered to 67.3%, up from July's 64.3%, the low point for the year, though still short of the 70%+ readings that were typical through most of 2025.
  4. Commercial FOIA Service closed 31.6% of the month's requests, edging past Individual/Citizen filers (30.0%) and ending their two-month run atop the requester rankings.
  5. FSVP requests logged their biggest month of the year by far: 53 closings at a 260-day median, more than double January's previous high. One food-import compliance firm clearing its own backlog accounts for most of it, but the underlying trend is real even without that batch. Full story below.

The Month in Numbers

Metric August 2026 July 2026 MoM
Requests Closed 1,026 935 +9.7%
Median Processing Time 27.5 days 23 days +19.6%
Release Rate 67.3% 64.3% +3.0 pts
Avg Processing Time 136 days 150 days −9.3%
Withdrawals 95 205 −53.7%
Formal Denials 0 0

Year-over-year: August 2026 closed 1,026 requests vs. August 2025's 734 (+39.8%), with a faster median (27.5 days vs. 41) but a lower release rate (67.3% vs. 77.2%) and a higher average (136 days vs. 108) — the same median/average split described below shows up YoY too.

Median Processing Time, Month by Month

Jan
██████████████████████████████
44d
Feb
████████████████████████████████████████
58.5d
Mar
█████████████████████████████████
48d
Apr
██████████████████
26d
May
████████████
17d
Jun
█████████████████████
31d
Jul
████████████████
23d
Aug
███████████████████
27.5d

Bar length (in block characters) proportional to median days, scaled to February's 58.5-day high. A handful of prior months shift slightly from issue to issue as late closings post to the FDA log; June's figure above reflects the log as of this issue, not the value reported last month.

One takeaway: after bottoming out at 17 days in May, the median has bounced between the low-twenties and low-thirties for four straight months now — nowhere near the mid-40s-to-high-50s that opened the year, but not the flat line we were watching for either. August's 27.5 keeps the recent run intact without confirming a new floor.

Withdrawals Cool Off. 

\White Mountain Films, closed 16 requests (a mix of Released and Withdrawn) concerning Novo Nordisk's GLP-1 drug safety signals and labeling reviews — filed in March and April, closing out over the summer. The name and subject matter suggest a documentary or media production researching GLP-1 side effects rather than a law firm or advocacy group, though the requester category field classifies it as Individual/Citizen.

The average-vs-median gap persists for the same reason it did in July: 64 of August's 1,026 closings had been open more than a year, and 29 had been open more than 1,000 days. FDA is still working genuinely old backlog alongside its current queue, and that backlog — not a slowdown in handling new requests — is what keeps pulling the average well above the median.

If you're filing across multiple doc types Two different filers used the same same-day open-and-withdraw pattern this month on drug-specific dossiers. If you're casting a wide net across FAERS, IND, Correspondence, and similar doc types for one product, expect to do some housekeeping once you see which requests actually come back with something useful.
Our take Withdrawals normalizing to 95 is the headline, but don't read it as "back to calm" — it's really "back to a different kind of busy." Two filers ran the same same-day batch-and-prune playbook on unrelated drugs in the same week. Worth watching whether that becomes a recurring pattern among commercial/legal filers or was a coincidence of timing.

Commercial Filers Retake the Lead

Individual/citizen requesters led monthly closings in both June (33.0%) and July (37.1%), but Commercial FOIA Service reclaimed the top spot in August, closing 31.6% of the month's requests against 30.0% for individuals. Unlike some of the swings we've flagged in prior issues, this one looks broad-based rather than driven by a single filer: the category's three biggest names — Registrar Corp (72 closings), Redica Systems (68), and Clarivate Analytics (63) — together account for a bit under two-thirds of the category's volume, with no one firm dominating the total.

Regulated Industry also grew its share, from 24.8% in July to 26.0% in August. Law Firm's share fell back to 5.8% from July's 8.6%, essentially the mirror image of the Zimmerman Reed batch unwinding — that spike doesn't recur without a comparable one-off filing.

Requester Type August 2026 % of Month July 2026 %
Commercial FOIA Service 324 31.6% 22.7%
Individual / Citizen 308 30.0% 37.1%
Regulated Industry 267 26.0% 24.8%
Law Firm 60 5.8% 8.6%
News / Media 49 4.8% 5.6%
Academic / Research 12 1.2% 0.9%
Advocacy / NGO 5 0.5% 0.4%
Government 1 0.1%

Nine Years On, an Essure Records Request Finally Closes

Control #2017-2830 · PMA · Essure (P020014) · 3,429 days waited

Requested: A records request tied to PMA supplement P020014 S12, the premarket approval file for Bayer's Essure permanent-birth-control device, filed in March 2017 by Amanda Dykeman, an administrator with the patient advocacy group Essure Problems and vice president of ASHES Nonprofit — the organization that spent years pushing FDA and Congress to restrict, then pull, the device.

Released: August 2026, roughly nine years and five months after it was filed.

Why it matters: The request was filed in the thick of the fight over Essure, well before Bayer discontinued U.S. sales at the end of 2018 and before the device came off shelves entirely in 2019. By the time FDA released these records, Essure had been off the market for close to seven years and the bulk of the related injury litigation had already been resolved. It's the same pattern we flagged with the Theranos request last issue: a record that answers a question the news cycle, and in this case a public health campaign, had already moved past.

Request this now: Search this record in the database.

More Notable Long-Waited Records

A running list of other interesting long-delayed releases surfacing in the log recently, not limited to August closings, but all recent enough to be fresh:

FDA-Peter Marks Correspondence on COVID-Era TestingControl #2020-3580 · 2,308 days · Kaiser Health News

Filed in May 2020 by a Kaiser Health News correspondent, this request sought emails from then-CBER Director Peter Marks concerning antibody, serology, and diagnostic testing dating back to February 2020 — the earliest and most chaotic weeks of the U.S. COVID-19 response. Released this August, over 6.3 years later, well after Marks's own high-profile departure from FDA became public.

NDMA in Ranitidine (Zantac)Control #2020-3504 · 2,290 days · Barr & Gulyas

A law firm's request for FDA records on NDMA contamination in ranitidine (Zantac), filed within weeks of the drug's April 2020 market withdrawal. Released in August, 6.3 years later, after the bulk of the multidistrict litigation over the same contamination issue had already reached settlement.

CBER Directors' Correspondence With a Shanghai CROControl #2022-5460 · 1,492 days · Judicial Watch

Judicial Watch's request for correspondence between two CBER directors — Gruber and Marks — and Shanghai Medicilon Inc., a China-based contract research organization. Filed in July 2022 and released this August, over four years later, amid continuing scrutiny of foreign CROs' role in FDA-regulated clinical research.

FSVP Wait Times Have Climbed 12x Since 2024. August Made It Worse.

FSVP (Foreign Supplier Verification Program) requests closed at a 13-day median in 2024 across 568 requests. In 2025 that slipped to 22 days across 836 requests. Through August 2026, the median across the 108 FSVP requests closed so far this year is 166.5 days — more than 12 times 2024's figure and roughly 7.5 times 2025's. This is the watch item we flagged as "still climbing" last issue, and the climb has accelerated.

August alone drove a big share of that: 53 FSVP closings, easily the year's largest single month (the next-highest was January's 39), at a 260-day median. Most of the volume — 41 of the 53 — came from Registrar Corp, a food-import compliance firm, closing out a batch of FSVP history requests it originally filed in November 2023. Batch requests filed together tend to clear together, which is exactly what happened here roughly nine months after filing.

Strip Registrar Corp's batch out entirely and the picture doesn't improve much: the remaining 12 August FSVP closings still carried a 165.5-day median, and the year-to-date median excluding Registrar Corp altogether is 131 days across 22 closings. The slowdown isn't a batch artifact — it's a real, broad-based degradation in how long FSVP requests are taking to close, batch or no batch.

If you track food-import compliance A 13-to-22-to-166-day median over three years is a big enough move that a request filed today should be planned around months, not weeks. If you're requesting FSVP records to verify a supplier's compliance history, build the current wait time into your timeline rather than last year's.
Our take FSVP is now one of the clearest multi-year degradation stories in the dataset, worse than the widely-discussed PMTA and Correspondence wait-time increases. Volume is still modest enough (108 closings in 2026 vs. 483's several hundred a month) that a single large batch can swing the monthly number sharply, as it did in August — but the underlying, batch-excluded trend has been consistently bad for two years running.

What We're Watching Going Into September

1. Does the requester-mix flip stick? Commercial FOIA Service edged out Individual/Citizen filers for the first time in three months. If September confirms it, that's a genuine shift in who's driving FOIA volume. If individual filers bounce back to the high-30s, August was the outlier.
2. FSVP — how much of September is Registrar Corp? August's FSVP spike leaned heavily on one filer's batch clearing. Watch whether September brings another large batch (from Registrar Corp or elsewhere) or a return to the single-digit monthly volumes seen from February through July, and whether the underlying (non-batch) wait time keeps climbing either way.
3. Median processing time — range or drift? Four months running (17, 31, 23, 27.5), the median has stayed in a band well below Q1's 44–58 day range without settling on a single number. A fifth month in that same band would start to look like a genuine new normal rather than noise.
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