FDA to expand drug research on pregnant women, filling decades-old safety gap
H.R. 8651 — Advancing Safe Medications for Moms and Babies Act of 2026 · Filed by Kathy Castor (D-FL) · 2 cosponsors · Introduced May 4, 2026 · Referred to committee
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What it does
This bill directs the FDA to update its regulations to make it easier for pregnant and lactating women to participate in clinical drug trials, establishes a $5 million/year public education campaign to inform patients and doctors about these trials, and funds the National Institutes of Health to prioritize research on drugs used by pregnant and lactating women. The goal is to fill a gap in medical knowledge about drug safety during pregnancy and breastfeeding.
Why we flagged it
The bill's operative mechanism is regulatory harmonization, public education funding, and research prioritization—all aimed at expanding the evidence base for drug safety in pregnancy and lactation. No private carve-outs, no liability shields, no narrow beneficiaries.
What the text implies
- Regulatory harmonization may create new compliance burdens for pharmaceutical companies conducting trials, potentially increasing trial costs and timelines—though the bill does not shield companies from these costs.
- The education campaign and research prioritization process may increase demand for enrollment in pregnancy-related clinical trials, which could accelerate drug development timelines for maternal health indications.
- By expanding the evidence base for drugs in pregnancy, the bill may reduce off-label prescribing and associated liability exposure for manufacturers—a secondary market benefit, not the bill's primary purpose.
Section numbers refer to the bill text the analysis read — linked under Primary records below.
Who it affects
Pregnant and lactating women currently lack adequate safety data for most medications because they have historically been excluded from clinical trials. This bill directly addresses that exclusion by requiring regulatory harmonization, funding research, and educating patients and providers—expanding access to evidence-based treatment options and improving maternal and infant health outcomes.
Who stands to gain
- pharmaceutical companies conducting maternal health research
- clinical research organizations specializing in obstetrics and pediatrics
- medical device manufacturers with pregnancy-related products
Named in the bill
FDA, HHS, NIH, NICHD (Eunice Kennedy Shriver National Institute of Child Health and Human Development), CDC, House Committee on Energy and Commerce
Where it stands
2 cosponsors: 1 Democrats, 1 Republicans.
- May 4, 2026 — Introduced · Congress.gov: “Introduced in House”
- May 4, 2026 — Referred to House Committee on Energy and Commerce · Congress.gov: “Referred to the House Committee on Energy and Commerce”
Dates and quoted wording are Congress.gov's action record; the timeline shows status changes, not every procedural step.
Money around this bill
1 lobbying clients named this bill on 1 disclosure filings across 1 quarter, Jun 2026 to Jun 2026. Those filings disclosed $96,000 in lobbying spend. A filing names 31 bills on average, so that figure is what each filing reported, not a share belonging to this bill.
More lobbying clients named this bill than 0% of bills with at least one filing.
Kathy Castor, the sponsor, reported $1,028,281 in PAC receipts in the 2026 cycle.
- American College of Obstetricians and Gynecologists — $96,000 on 1 filing
Lobbying Disclosure Act filings through Jul 20, 2026. A filing shows who paid to lobby on a bill it names, not what changed.
How this was measured
Analysis — Quorum's AI read the bill text published by Congress.gov (7,865 characters) on Aug 12, 2026. Section numbers in the findings refer to that text, linked below; transparency and hidden-provision scores are compared against the median of 16,222 analysed bills.
Status and sponsors — Congress.gov's bill record — actions, committee referrals and cosponsors — loaded nightly. The timeline shows status changes, not every procedural action.
Money — Senate Lobbying Disclosure Act filings whose specific-issue field names this bill for quarters ending Jun 2026 to Jun 2026. A filing's amount is reported whole beside the median number of bills a filing names; it is never divided across them. PAC receipts are FEC-reported contributions to the sponsor's candidate committee in the 2026 cycle.
As of — lobbying records through Jul 20, 2026 · page rendered 2026-10-20.
“FDA to expand drug research on pregnant women, filling decades-old safety gap” QuorumCivic. https://share.quorumcivic.app/bill/119/hr8651 Report an error
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