FDA FOIA Monitor
Why is the September issue published in October? 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 September 1 through September 30. New here? Start with the 2020–2026 Baseline Report for full historical context.
Five Things That Changed in September
- FDA closed 1,449 requests in September, up 41% from August's 1,026 and the most closings of any month in the log since 2020.
- Median processing time jumped to 48 days, from August's 27.5. That ends a four-month run in the 17–31 day range and puts the median back at March's level.
- Release rate slipped to 64.3%, from 67.3% in August, matching July's low for the year.
- FDA issued 186 "no records" responses, the most of any month since 2020. One filer, Registrar Corp, accounts for 78 of them.
- Law firms nearly doubled their share of closings, to 9.4% from 5.8%. One firm filed 35 requests on a single supplement marketer's products and withdrew 29 of them three weeks later. Full story below.
The Month in Numbers
| Metric | September 2026 | August 2026 | MoM |
|---|---|---|---|
| Requests Closed | 1,449 | 1,026 | +41.2% |
| Median Processing Time | 48 days | 27.5 days | +74.5% |
| Release Rate | 64.3% | 67.3% | −3.0 pts |
| Avg Processing Time | 177 days | 136 days | +30.1% |
| Withdrawals | 100 | 95 | +5.3% |
| Formal Denials | 0 | 0 | Flat |
Year-over-year: September 2026 closed 1,449 requests vs. September 2025's 1,107 (+30.9%), but with a slower median (48 days vs. 34.5), a lower release rate (64.3% vs. 80.8%) and a much higher average (177 days vs. 98).
Median Processing Time, Month by Month
Bar length (in block characters) proportional to median days, scaled to February's 58.5-day high. Prior months match the figures in last issue.
One takeaway: we asked last month whether a fifth month in the 17–31 day band would make it the new normal. September answered no. Part of the jump comes from one large batch of old requests clearing at once (see the Deep Dive), but even without that batch the median sits at 36 days, still above the summer range.
Batch-and-Prune Becomes a Pattern
Last issue we flagged two filers who opened batches of drug-specific requests and quickly withdrew most of them, and asked whether that would recur. It did. Farra & Wang PLLC filed 35 CAERS requests in late August, each seeking adverse event reports for a dietary supplement sold by New Market Health Products under one of eight brand names. FDA released records on 3, found none on 3, and the firm withdrew the other 29, all at the 21-day mark.
The month also cleared a lot of old backlog. 135 of September's closings had been open more than a year, and 47 more than 1,000 days, up from 64 and 29 in August. That backlog explains most of the jump in the average, from 136 days to 177.
Commercial Filers Hold the Lead, With an Asterisk
Commercial FOIA Service stayed on top in September at 32.2% of closings, against 30.7% for Individual/Citizen filers. Unlike August, though, one firm drove most of it. Registrar Corp closed 194 requests on its own, about 42% of the category. Redica Systems (118) and Clarivate Analytics (43) followed. Without Registrar Corp, commercial filers would trail individuals by a wide margin.
Law Firm share jumped to 9.4% from 5.8%, mostly on the Farra & Wang batch and a run of follow-on requests from Ashurst Perkins Coie. Regulated Industry fell to 20.0% from 26.0%, its lowest share since March.
| Requester Type | September 2026 | % of Month | August 2026 % |
|---|---|---|---|
| Commercial FOIA Service | 467 | 32.2% | 31.6% |
| Individual / Citizen | 445 | 30.7% | 30.0% |
| Regulated Industry | 290 | 20.0% | 26.0% |
| Law Firm | 136 | 9.4% | 5.8% |
| News / Media | 67 | 4.6% | 4.8% |
| Academic / Research | 34 | 2.3% | 1.2% |
| Advocacy / NGO | 10 | 0.7% | 0.5% |
| Government | 0 | 0.0% | 0.1% |
Two Generic-Drug Sample Requests Close on the Same Day, Years Late
ProPublica · REMS · Filed Aug 2017 · 3,326 days waited
STAT · ANDA · Filed Mar 2018 · 3,109 days waited
Requested: In August 2017, ProPublica asked for complaints FDA received about brand companies using REMS safety programs to block generic makers from buying drug samples for testing, plus any related correspondence with the FTC or DOJ. Seven months later, STAT asked for CDER correspondence about generic applications that ran into the same problem.
Released: Both on September 30, 2026, about 9.1 and 8.5 years after filing.
Why it matters: Generic developers need brand samples to run bioequivalence studies, and sample access was one of the hottest fights in drug pricing when these requests went in. FDA began publicly naming companies flagged in sample-access inquiries in 2018, and Congress passed the CREATES Act in December 2019, giving generic makers a way to sue over withheld samples. These records describe a problem that Congress addressed almost seven years ago, the same pattern we've seen with the Essure and Theranos releases in earlier issues.
Request this now: Search these records in the database.
More Notable Long-Waited Records
Other long-delayed releases that surfaced in September's log:
The Wall Street Journal filed both in 2016, at the height of its reporting on Theranos. The first sought emails between a U.S. Army employee and FDA officials about the company; the second asked for records on Theranos's technology and regulatory strategy. FDA released both on September 4, more than ten years after the first went in and long after Theranos shut down.
A law firm's request for the complaint Eli Lilly filed with FDA challenging Novartis's marketing claims for Kisqali (ribociclib), including the claim that it "improves or preserves quality of life." Kisqali competes directly with Lilly's Verzenio in breast cancer. A rare look at one drugmaker policing a rival's promotional claims through FDA.
Memorial Sloan Kettering requested full FAERS case data on 12 reports of T-cell lymphoma in patients treated with four CAR-T therapies. The request went in December 2023, weeks before FDA required boxed warnings on CAR-T products for T-cell cancers. FDA released the case files in September, more than two years after that label change.
One Filer, Three Headlines
Registrar Corp, the food-import compliance firm behind August's FSVP spike, shaped September's numbers even more. It closed 194 requests, 13% of the month. Most ask for the same thing: a spreadsheet of the "23 publicly available data points" behind a named company's appearance on an FDA list, such as the FSVP importer list or an import alert. Half of its September closings (95) came from a single batch filed in December 2025.
That one filer touches three of this month's headlines:
- Median. Registrar Corp's closings carried a 255.5-day median. Take them out and the month's median drops from 48 days to 36.
- No records. FDA found nothing for 78 of its requests, 42% of the month's 186 "no records" responses. Without Registrar Corp, the no-records rate is 8.6%, close to the 8.0% monthly average for 2026.
- FSVP. FSVP logged another record month with 129 closings, 70 from Registrar Corp. The other 59 closed at a 163-day median, so the slowdown we described last issue holds without the batch.
The volume story survives the adjustment, though. Without Registrar Corp, FDA still closed 1,255 requests, more than any other month this year.