NIH PRGLAC Recommendations and Women's Health Policy Changes

Nearly every pregnant or lactating person in the country takes at least one medication during that period, and clinical trials have historically excluded exactly this population from the research that would tell doctors whether those drugs are safe or at what dose they actually work⟦c2⟧⟦c3⟧. That's the gap the NIH's PRGLAC task force set out to name, and its 15 recommendations have since become the closest thing federal policy has to a repair plan⟦c2⟧.

PRGLAC's own framing of the problem cuts against decades of research custom. The old logic in obstetric research was protective in a narrow sense: keep pregnant and lactating women out of trials so they can't be harmed by the research itself⟦c4⟧. PRGLAC flipped that logic. Protection, in its view, has to come through research, not from avoiding it, because avoiding it just means doctors keep prescribing blind⟦c4⟧.

What does "prescribing blind" look like in an exam room? A clinician sees a pregnant patient with depression, an autoimmune flare, or a bacterial infection, and has to pick a dose without pharmacokinetic data specific to pregnancy, a state that changes blood volume, kidney clearance, and liver metabolism enough to shift how nearly any drug behaves⟦c5⟧. The patient, meanwhile, is left weighing a known, visible fear (will this medication harm her fetus or infant) against a risk that gets far less airtime: what untreated disease does to her and to the pregnancy. NICHD Deputy Director Catherine Y ⟦c5⟧. Spong, M.D., has pointed to exactly this asymmetry, noting that harm from the disease itself tends to get discussed far less than harm from the drug, even though both are real⟦c5⟧⟦c6⟧.

These numbers come from the article's data and carry direct real-world weight. A 2025 landscape analysis built on the MPRINT Knowledge Portal dataset found that only 36% of current drug labels carry any information for nursing mothers⟦c8⟧. Only 27% include anything for pregnant or pediatric patients⟦c9⟧. Just 6.5% address teratogenicity, a drug's potential to cause birth defects⟦c10⟧, and only 7% say anything about use during labor and delivery⟦c11⟧. Those aren't academic gaps. That label is the exact document a clinician reaches for at the point of care, and for most drugs, on most of the questions a pregnant or breastfeeding patient will ask, it says nothing.

PRGLAC's creation and the people it brought to the table

NICHD, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, took the lead agency role⟦c13⟧.

The membership list reads like a cross-section of every federal body with a stake in the problem. Directors or their designees came from NIH, NICHD, the CDC, the Office on Women's Health, the National Vaccine Program Office, AHRQ, and HRSA⟦c15⟧, alongside the FDA Commissioner⟦c16⟧ and the Secretaries of the Department of Veterans Affairs and the Department of Defense⟦c17⟧. Non-federal seats went to medical societies, nonprofits, and companies working on pregnant women's, nursing mothers', or children's health. That breadth wasn't decorative. The evidence gap spans regulatory approval, clinical practice, and drug commercialization all at once, so any credible fix needed people from all three worlds in the room at the same time ⟦c26⟧.

The chronology matters for tracking what came next. PRGLAC delivered its 15-recommendation report in 2018, formally submitted those recommendations to the HHS Secretary in 2019, issued an Implementation Plan in 2020, and saw its charter expire in 2021⟦c18⟧. What survived that expiration is the subject of everything that follows.

What the 15 PRGLAC recommendations call for

The 2018 report's 15 recommendations were organized into clusters for implementation review, a structure that appears in the PRGLAC Implementation Working Group's June 2024 slides and its July 2024 Progress Report⟦c19⟧.

Cluster A covers the actual conduct of clinical research and trials⟦c20⟧. Recommendation 1 calls for integrating pregnant and lactating women into the clinical research agenda outright, rather than treating them as a special add-on population⟦c21⟧. Recommendation 2 asks for more research, better research, and faster research on the safety and efficacy of therapeutic products this population actually uses⟦c22⟧. Recommendation 10 pushes for a proactive approach to protocol design, meaning trials should be built from the start to include these patients rather than exclude them by default⟦c23⟧. Recommendation 11 calls for using existing infrastructure and building new collaborations to make that research possible⟦c24⟧.

Cluster B is about people: the workforce and the public conversation around this research⟦c25⟧. Recommendation 3 calls for expanding the pool of clinicians and investigators trained in obstetric and lactation pharmacology, a subspecialty that's thin on the ground⟦c26⟧. Recommendation 5 asks for a public awareness campaign aimed at both patients and providers⟦c27⟧, and Recommendation 6 calls for evidence-based communication strategies so that whatever gets learned actually reaches the clinicians who need it⟦c28⟧.

Cluster C covers policy, regulatory, and liability issues⟦c29⟧. Recommendation 4 calls for removing regulatory barriers to research in pregnant women⟦c30⟧, while Recommendation 7 addresses liability directly, aiming to reduce the legal exposure that discourages companies from building an evidence base for products used by women who are pregnant, might become pregnant, or are lactating⟦c31⟧.

Cluster D is about data infrastructure ⟦c1⟧. Recommendation 12 calls for using and improving existing data resources to build a foundation for future research⟦c33⟧, and Recommendation 13 specifically targets pregnancy and lactation registries, asking that they be optimized rather than left as scattered, underused databases⟦c34⟧.

Cluster E looks toward drug discovery itself ⟦c1⟧. Recommendation 9 goes further, calling for programs that drive discovery of new therapeutics aimed specifically at conditions unique to pregnancy and lactation⟦c37⟧.

Two recommendations sit outside the five clusters because they're structural rather than substantive ⟦c22⟧⟦c27⟧. Recommendation 14 asked the HHS Secretary to consider extending PRGLAC's charter past its original March 2019 expiration, and that's what happened when it got pushed to March 13, 2021⟦c38⟧. Recommendation 15 called for an Advisory Committee to monitor and report on implementation of recommendations, updating regulations and guidance as applicable regarding the inclusion of pregnant and lactating women in clinical research⟦c39⟧.

That's the full scope, and the specificity itself demands attention. This isn't a report that says "do more research." It names workforce shortages, liability law, registry design, and off-patent drug economics as separate, distinct failure points, each requiring its own fix. Recommendation 8 calls for developing separate programs to study therapeutic products used off-patent in pregnant women and lactating women using the NIH BPCA as a model ⟦c36⟧.

Gaps for pregnant women in the existing NIH inclusion policy

NIH already has a baseline inclusion policy on the books, and it's a useful reference point for understanding why PRGLAC needed to exist at all ⟦c1⟧. Under current policy, all NIH-funded clinical research must include women and members of racial and ethnic minority groups, and cost isn't an acceptable reason to exclude them⟦c40⟧. Women of childbearing potential aren't supposed to be routinely excluded either, language that's already baked into policy⟦c40⟧.

For pregnant women specifically, the language softens. NIH "strongly encourages" including pregnant women wherever that inclusion is scientifically valid and ethically permissible⟦c41⟧. Encouragement isn't a mandate, and that distinction is the entire ballgame. The legal backbone here is 45 CFR 46, Subpart B, titled "Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research," and true to its name, it sets conditions under which pregnant women can be included rather than requiring that they be⟦c42⟧.

There's a separate wrinkle for Phase III trials ⟦c43⟧. Investigators there have to review whether an intervention produces clinically relevant differences by sex and design the trial accordingly⟦c43⟧. That sounds like it should cover pregnancy, but it doesn't, because pregnancy is a physiological state, not a sex category, and a policy built around sex differences doesn't automatically capture what changes in a pregnant body⟦c43⟧.

Recommendation 1B, which calls for harmonizing FDA regulations with the Common Rule found in 45 CFR 46, Subpart A, is directly responsive to this gap, and as of the July 2024 Progress Report, it was still in progress⟦c45⟧. A general inclusion mandate does not address how pregnancy changes drug metabolism, liability, or the regulatory pathway, which is exactly where PRGLAC's recommendations concentrate ⟦c44⟧.

Implementation status of all 15 recommendations in the 2024 Progress Report

Christina Bucci-Rechtweg, M.D., Global Head of Pediatric and Maternal Health Policy at Novartis Pharmaceuticals, and Susan Abdel-Rahman, Pharm.D., Chief Scientific Officer of the Health Data Synthesis Institute, co-chaired the effort⟦c47⟧⟦c48⟧.

None of this happened on goodwill alone. The Consolidated Appropriations Act of 2023 (P.L ⟦c50⟧. 117-328) put $200,000 behind the Advisory Committee and legally required the Secretary to submit a progress report to Congress within 180 days⟦c50⟧⟦c51⟧. Congress, in other words, attached a deadline and a modest budget line to Recommendation 15, and that's a large part of why the report exists on the timeline it does ⟦c2⟧.

The regulatory cluster is the clearest place to measure real structural change, and the results are mixed. Recommendation 1B, on FDA harmonization with the Common Rule, remained in progress as of the report⟦c53⟧. Recommendation 1C, which called for HHS guidance to facilitate research in this population, had not been implemented at all as of the report⟦c54⟧. One step in the regulatory framework remained unimplemented: SACHRP was charged with reviewing ongoing OHRP efforts directed toward protections for human subjects, with particular emphasis on pregnant women⟦c55⟧.

Progress elsewhere was uneven across the other clusters, but the regulatory cluster's stall is the most telling, because it's the one PRGLAC itself flagged as foundational to everything else ⟦c1⟧. Recommendation 4 called for removing regulatory barriers to research in pregnant women, and Recommendation 7 called for reducing liability to facilitate an evidence base for new therapeutic products that may be used by women who are, or may become, pregnant and by lactating women⟦c30⟧⟦c31⟧⟦c73⟧. The report's own language on this is blunt: it states that research has proven resistant to change, and that progress demands not just individual policy actions but a cultural shift in how the field treats this population⟦c56⟧.

The 2025 PMC landscape analysis shows the scale of what's left to do ⟦c7⟧. Pharmacotherapy knowledge gaps are highest in postpartum women (51.37%), followed by pregnant women (32.47%), and pediatric patients ages 0–12 (25.82%) and 12–18 (32.11%)⟦c57⟧. The PRGLAC Implementation Working Group of Council was formed in 2023 as a subgroup of NICHD's NACHHD Council (itself the fulfillment of Recommendation 15) ⟦c46⟧. Meetings began November 2023; findings were presented to NACHHD Council on June 3, 2024; and the Progress Report was released in July 2024 ⟦c49⟧.

The MPRINT Hub and the research infrastructure built to generate the missing evidence

If the regulatory cluster shows where PRGLAC has stalled, the MPRINT Hub shows where it has actually built something durable ⟦c1⟧⟦c58⟧. NICHD set up MPRINT as a national resource meant to gather, present, and grow the field's knowledge, tools, and expertise in maternal and pediatric therapeutics, and it serves researchers, regulatory scientists, and drug developers alike, while also running its own therapeutics research in obstetrics, lactation, and pediatrics⟦c58⟧.

The centerpiece of that resource is the MPRINT Knowledge Portal, or MPRINT-KP, designed through a partnership between The Ohio State University and Indiana University starting in 2021⟦c59⟧. As of April 1, 2025, it holds 758,560 clinical pharmacology research papers covering maternal and pediatric populations⟦c59⟧. It functions as both the research tool meant to close the gap and the instrument that measures how wide the gap still is, which is a fairly unusual dual role for a single database to play.

Other projects sit under the same umbrella. The CUDDLE Study (Commonly Used Drugs During Lactation and Infant Exposure) generates dosing guidance for mother and infant during breastfeeding, and in 2023 it added three new drugs to its scope: amoxicillin, buprenorphine, and hydrocodone, all three chosen because of how heavily they're actually used in lactating populations⟦c61⟧.

NICHD's RADx Tech for Maternal Health Challenge takes a different angle entirely, prioritizing home-based or point-of-care diagnostic devices, wearables, and remote sensing technology meant to extend postpartum care into regions where maternity care access is thin⟦c62⟧. Phase 2 winners included 3CPM Company, Inc., Endometrics LTD, the Feinstein Institutes for Medical Research at Northwell Health, and Washington University in St. Louis⟦c63⟧, with grand prize winners announced in October 2024⟦c64⟧.

Perhaps the clearest example of the granular data PRGLAC's agenda was built to produce came out of NICHD: a study examining 3,974 human milk samples from participants on long-term medications, including SSRIs, corticosteroids, and anti-inflammatory drugs, compared against untreated healthy matched controls⟦c65⟧. Certain SSRIs and corticosteroids were tied to lower protein and fat levels in human milk, while carbohydrate content remained stable⟦c65⟧. That's the exact texture of evidence a drug label needs and currently, in most cases, doesn't have. The 2025 NICHD Strategic Plan reflects this directly, naming the ongoing need for more data on how pregnant and lactating women metabolize therapeutics and pointing to collaboration with established, successful organizations as the path forward⟦c66⟧. The Portal is also the dataset behind the 2025 landscape analysis quantifying label gaps, serving as both a research tool and a measure of how much evidence currently exists ⟦c60⟧.

NASEM's December 2024 report on a persistent structural gap in NIH's women's health coverage

A NASEM report released in December 2024 stated that female-specific conditions such as fibroids, endometriosis, PCOS, and aspects of the menopause transition are not within the purview of any specific Institute or Center, though the same report separately notes the menopause transition falls under the National Institute on Aging⟦c67⟧.

NICHD Director Diana W ⟦c68⟧. Bianchi, M.D., pushed back publicly, arguing the report doesn't reflect the full scope of NIH's existing women's health research and leaves out the congressional language that specifically assigns gynecological and pregnancy-related conditions to NICHD⟦c68⟧⟦c69⟧.

PRGLAC's 15 recommendations address the therapeutic evidence gap for pregnant and lactating women specifically⟦c70⟧. NASEM's critique is about something else: a coverage gap for non-reproductive, female-specific conditions that don't have a clean institutional home⟦c70⟧. Different problems, same root cause. Both point to a structural reality where women's health as a category gets split across NIH institutes in ways that leave ownership genuinely ambiguous in places, and that ambiguity produces gaps regardless of how well any single program performs⟦c71⟧. Nothing in the record resolves this dispute. It's an open institutional argument, not a settled one, and how NIH answers it going forward will matter ⟦c14⟧.

The impact of federal budget disruptions since 2025 on PRGLAC's unfinished agenda

Set against all of this is the Women's Health Initiative, NIH's longest-running and largest effort focused specifically on women's health, now in its fourth decade and still enrolling participants, with roughly 42,000 currently in the study⟦c72⟧. It stands as proof that sustained, decades-long federal commitment to women's health research is possible and can produce results at scale.

Regulatory harmonization efforts, registry optimization, and workforce development programs are the sort of initiatives that stall easily when funding gets disrupted or reprioritized, precisely because their payoff arrives years after the appropriation does.