Legislative and regulatory tracking that reads every bill and rule overnight and shows which of your products it reaches
Every relevant bill and rule read overnight and briefed with sources.
See one case, screen by screen ↓Software that follows bills, rules, guidance, board actions and hearings across Congress, the states and the agencies, and tells a policy team what changed. Legislative & Regulatory Tracking adds six agents that read every source overnight, redline each new version, score it 0–100 against your issues and products, and write a cited brief for each lead — for a policy analyst to confirm.
How to choose AI solutions for life sciences →
Updated
A pharma policy team follows Congress, all 50 state legislatures, CMS, FDA, HRSA, FTC and Commerce, the state prescription drug affordability boards and the committee hearings — on the handful of issues that move net revenue: Medicare drug price negotiation, PBM reform, 340B, price caps, patents and biosimilars, tariffs and patient out-of-pocket costs. Analysts find items in feeds and alerts, read them, and write the morning brief for each lead by hand.
Then comes the question every lead asks first: which of our products does this reach, and through which channel? That goes by email to Market Access and takes days. A late-evening committee vote or a new version is found the next morning, so a lead walks into the morning staff meeting without the amendment text. Comment windows at the boards and on the CMS and FDA dockets are short, and a missed one cannot be recovered.
Estimated split for one analyst on a mid-size manufacturer's watch list, by hand and with the solution — about 11 hours a week back.
Six specialist agents watch, read, score, trace and brief; a policy analyst confirms every score before anything is sent.
Northwind Bio sells three medicines: Veltrimab, a self-injected biologic; Corventa, an oral oncology drug selected for the 2028 negotiation cycle; and Talmirex, a clinic-administered Part B product. At 21:40 on Tuesday, October 6, Senate Finance reports a PBM bill with a manager's amendment. Here is what happens next, screen by screen, in the working solution.
Tuesday's evening edition read 412 documents since 06:00, 96 of them on Northwind's issues. It leads with the Colorado Prescription Drug Affordability Review Board's hearing on Talmirex, impact 84: written comments are due Oct 16, and a finding could lead to an upper payment limit. The alert has already gone to Dana Okafor, copy Sam Patel. The overnight sweep starts at 23:00.
“The board will decide whether Talmirex is unaffordable for Colorado consumers.”
The Source Watcher finds that Senate Finance reported S. 2187 19–8 and that the Michigan House passed HB 5814 58–50 — 1,284 documents read. The Provision Extractor redlines S. 2187 as reported: 2 sections inserted, 2 changed, 1 struck. The Hearing Listener reads the Finance executive session: 9 speakers, 3 mentions of our issues. The Impact Scorer rescores S. 2187 from 54 to 86 and HB 5814 from 66 to 81, and the Brief Writer drafts the alert to Omar Haddad.
“Front page set · alert to Omar Haddad drafted, waits for Lena Ortiz.”
The Morning Policy Brief opens on S. 2187, the Pharmacy Benefit Manager Delinking and Transparency Act of 2026: delinking extended to employer plans from 2028, a quarterly report of every rebate and fee manufacturers pay to PBMs, penalties up to $100,000 a day. The impact meter shows the five factors — issue match 24, product exposure 21, effect on us 19, likelihood of moving 13, timing 9 — with the score before the amendment marked. The rail holds the 07:00 brief for each issue.
“1,284 documents read overnight · 318 on our issues · 7 scored 80 or more · 3 wait for your confirmation · 5 briefs go at 07:00.”
Under the lead story, four columns trace each provision to the products it reaches: In the text, What it changes, Where we feel it, Our products. Sec. 3 brings employer and commercial plans in from January 2028; Sec. 4 adds a quarterly filing by drug and by plan sponsor; Sec. 4(c) means a missed quarter costs up to $9M. Veltrimab (Part D 41%, commercial 52% of US net sales) and Corventa (Part D 63%) are reached. Talmirex is not: it is a Part B, clinic-administered product.
“Exposure set with Market Access (Sam Patel) · Q3 channel mix.”
The item page compares the introduced text of Mar 12 with the text as reported on Oct 6. Sec. 3 (group health plans) and Sec. 4 (manufacturer reporting) are new; Sec. 2 moves from 2027 to 2028 and Sec. 5 moves PBM reports to plan sponsors from semi-annual to quarterly; Sec. 6, the rebate pass-through study, is struck. Beside it, every factor in the score carries its reason and the passage behind it.
The Provision Extractor quotes legal text in a provision record — it never paraphrases it.
From the 2 h 41 min transcript, the Hearing Listener pulls the three mentions that matter. The chair, Sen. Alder Whitfield, says the amendment requires manufacturers to report every rebate and fee they pay to PBMs, every quarter. The ranking member, Sen. Rosa Calder, hopes to take the bill to the floor before the end of the year. The clerk records the vote: yeas 19, nays 8.
The Hearing Listener quotes speakers exactly and never infers a vote that was not recorded.
Lena reads the factors and the passages and chooses “Confirm 86 and send to Omar”. The alert goes to Omar Haddad, VP Federal Government Affairs, copy Sam Patel, at 06:41: three changes that matter to Northwind, why they matter for the Veltrimab and Corventa rebate contracts, and a citation on every sentence. Contacts with officials that follow are logged under issue codes PHA and MMM.
“Confirmed and sent. Alert went to Omar Haddad, copy Sam Patel · Oct 7 · 06:41, confirmed by Lena Ortiz.”
Michigan HB 5814 would bar manufacturers from restricting 340B drugs shipped to contract pharmacies and from requiring claims data, with each package a separate violation. The scorer proposes 81, up from 66; it routes to Dana Okafor ahead of the Senate Health Policy hearing on Oct 21. Lena can confirm it, set it to watch only, or adjust the score — and an adjustment is not saved without a reason.
“Reason (required — it teaches the scorer and goes on the audit trail).”
Omar's daily brief is ready for approval: 6 items, 15 citations, ordered act now and this week — S. 2187, the Corventa negotiation period ending Nov 1, CMS's draft renegotiation guidance with comments due Nov 14, the HELP hearing where a senator described Veltrimab patients whose copay assistance did not count toward their deductible. The FTC staff report scored 52 and goes to the weekly digest. Lena can untick any item, have it written again, preview the email, then approve and send.
The Brief Writer never includes an item the analyst has not confirmed.
Over the last 7 days the dashboard shows 8,940 documents read, 2,106 matched to Northwind's issues and 23 high-impact alerts, each confirmed by an analyst before sending. The median time from a change to the lead's alert has come down week by week, from 71 minutes on Sep 9 to 38 on Oct 7, against a target of 60.
The same overnight vote, seen by the five people who carry it — what their morning looked like, and what it looks like now.
Six specialist agents watch, read, score, trace and brief; a policy analyst confirms every score before anything is sent.
Reads Congress, all 50 state legislatures, the Federal Register, the CMS, FDA, HRSA and FTC dockets, the affordability boards and committee transcripts every sweep, and spots new items and new versions of tracked ones.
Splits each text into sections and records who must do what, from when and with what penalty, with the exact passage — and redlines every new version: inserted, changed and struck.
Reads committee and board transcripts the same day, identifies each speaker and role, and pulls every mention of our issues and products, linked to the item it concerns.
Scores each item 0–100 on five factors — issue match, product exposure, effect on us, likelihood of moving and timing — each with its reason and passage, and traces the path from each provision to the products it reaches.
Writes the alert and the daily and weekly briefs for each lead — only their issues, a headline and one or two plain sentences per item, the clock and a suggested next step.
When a lead records a contact with a covered official about an item, logs the date, the office, the item and its issue code for the quarterly lobbying report, and flags entries without a code before the quarter closes.
Confirms or adjusts every score. The agents propose; a named person decides.
Ask in plain words about a bill, a rule, a hearing, a product or a deadline — or say what to change. Answers about bills and rules cite the passage behind them.
What changed overnight that matters most?
Two tracked items changed status and moved into high impact: S. 2187, reported 19–8 with a manager's amendment, 54 → 86; and Michigan HB 5814, passed the House 58–50, 66 → 81. The big one is S. 2187: a new quarterly report of every rebate and fee we pay to PBMs, with penalties up to $100,000 a day. Its alert to Omar Haddad waits for your confirmation.
What is happening on 340B in the states?
Michigan HB 5814 passed the House 58–50, with a Senate hearing on Oct 21; Illinois SB 1987 is on the veto-session calendar for Oct 27. Michigan's bill would make each package a separate violation. Talmirex is most exposed: 31% of its units go through 340B sites.
Add a rule: alert Dana on any 340B hearing in Tennessee
Done. Any Tennessee committee hearing, interim study or pre-filed bill on 340B now alerts Dana Okafor at once, whatever its score. Tennessee has no active 340B item today; pre-filing for 2027 opens in November. The rule is on in Settings and on the audit trail.
When are the Colorado comments on Talmirex due?
The Colorado board will decide whether Talmirex is unaffordable. Written comments are due Oct 16, and a finding could lead to an upper payment limit. Oregon's board is asking for the same power. Dana Okafor has the alert; Sam Patel is copied.
13 screens from the working solution, on its sample data. Pick one to see it large.
Thresholds, routing, sources and rules are settings — every change is versioned and on the audit trail.
| Setting | Default | Choose from |
|---|---|---|
| Alert the lead at once when impact reaches | 80 | 75 · 80 · 85 |
| Put an item in the daily brief from | 55 — below goes to the weekly digest | 50 · 55 · 60 |
| Rescore when a tracked item changes | On — new version, new action, hearing or vote | On · Off |
| Who gets what (federal items, by issue) | PBM reform & rebates → Omar Haddad | Omar Haddad · Dana Okafor · Sam Patel · Priya Raman · Dr. Maya Chen |
| Daily brief, sent after you approve | 07:00 ET, weekdays | 06:30 · 07:00 · 07:30 ET |
| Weekly leadership brief | Friday 15:00 ET | Friday 15:00 ET · Monday 08:00 ET |
| Where briefs and alerts arrive | Email and team chat | Email and team chat · Email only |
| Log contacts with officials that follow from an alert | On — each with its issue code (MMM, PHA, HCR, CPT, TRD) | On · Off |
Every figure is labelled: a target the solution is built to, an estimate, a typical published result, or a proven one.
“demo” = seen in the working solution, on its sample data · “target” = the design goal, measured in the live solution · “estimated” = our estimate before deployment · “typical” = published public-affairs benchmarks (130,000+ US state bills in 2025). People, the company Northwind Bio and the products Veltrimab, Corventa and Talmirex named on this page are fictional — characters and sample data in the working solution; bill numbers, votes and hearing quotes are its sample data.
Software that follows bills, rules, guidance, board actions and hearings across Congress, the states and the agencies, and tells a policy team what changed. Legislative & Regulatory Tracking adds six agents that read every source overnight, redline each new version, score it 0–100 against your issues and products, and write a cited brief for each lead — for a policy analyst to confirm.
Congress, all 50 state legislatures and DC, the Federal Register, the CMS, FDA, HRSA and FTC comment dockets, the state prescription drug affordability boards and federal and state committee hearing transcripts. All are public sources, read only; a commercial bill-tracking feed can be added alongside.
The Impact Scorer scores five factors — issue match by your issue weights, product exposure, the new obligation on the company, the likelihood of moving and timing — each with a short reason and the passage or transcript line behind it. When an item changes, it rescores and shows the old and new values, as S. 2187 went from 54 to 86 in the working solution.
From the exposure your policy team sets with Market Access: each product's channel mix, such as Part D, commercial or Part B share of US net sales, and 340B share of units. The path on each item shows the provision, what it changes, where it is felt and the products reached — and the products not reached, with the reason.
Yes. The Hearing Listener reads transcripts the same day, names each speaker and pulls every mention of your issues and products. Board agendas, hearing notices and comment deadlines are tracked items with their own clocks, such as the Colorado review of Talmirex with comments due Oct 16.
It logs contacts with officials that follow an alert, each with its issue code — MMM, PHA, HCR, CPT or TRD in the working solution — and flags entries without a code before the quarter closes. Government affairs operations reviews and approves the log; the agent never files the report.
Yes. Every score is a proposal until a policy analyst confirms it, adjusts it with a reason or sets it to watch only. No alert or brief leaves before the analyst approves it, every sentence is cited, and every decision is on the audit trail.
The Agentic Solution Engine builds and deploys it from your requirements and documents — your issue list and weights, your products and their channel mix, your leads and routing — and it goes live once every quality gate has passed. We will walk you through it on the bills and rules you are following now.
Every answer drawn from one evidence library, cited and owner-approved.
1-min demoEarnings Call PreparationLikely analyst questions answered from approved disclosures, cited.
1-min demoPartnering Opportunity TriageEvery inbound pitch scored and answered within days, earlier decisions brought back.
1-min demoWe'll run Legislative & Regulatory Tracking on your own issue list, products and the bills you are following now.