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NewsNewsEMD Serono will offer steep IVF drug discounts via TrumpRx.gov in 2026 and seek expedited FDA review for Pergoveris, aligning with a White House order.
Merck announces an agreement with the U.S. government to expand access to IVF therapies through deep price reductions, a new federal purchasing platform, and a planned expedited FDA filing for Pergoveris to broaden treatment options for complex fertility cases.
EMD Serono, the healthcare business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, announced a public‑private agreement with the U.S. administration to expand access to its in vitro fertilization (IVF) therapies for more than 10 million American women struggling to conceive, aligning with a White House Executive Order on affordable IVF access and unveiled at a White House fertility event. Under the agreement, EMD Serono will offer direct‑to‑consumer sales of its IVF portfolio, Gonal‑f, Ovidrel, and Cetrotide, at significantly reduced prices for eligible patients with prescriptions, with discounts reaching 84% off list prices when the three medicines are used together in a typical IVF protocol.
Access will be facilitated via TrumpRx.gov, a direct purchasing platform scheduled to go live in January 2026, alongside continued availability through EMD Serono’s existing pharmacy network and an expanded network from early 2026, positioning the arrangement as both a pricing measure and a distribution expansion for fertility medications in the U.S. market. EMD Serono also reached a separate agreement with the U.S. Secretary of Commerce providing exclusions from Section 232 tariffs for its pharmaceutical products and ingredients, contingent on future investment in biopharmaceutical manufacturing and research in the United States.
Merck KGaA leadership framed the move as a long‑term U.S. commitment. “We have a strong presence in the U.S. across all three of our business sectors, with a significant number of our employees based in this key market and look forward to growing our footprint here even further with future fertility manufacturing,” said Belén Garijo, Chair of the Executive Board and CEO of Merck KGaA, Darmstadt, Germany, adding that the company is committed to ensuring patients and customers benefit from portfolio innovation over the long term. Danny Bar‑Zohar, CEO of Healthcare and Member of the Executive Board, added, “As a result of our collaboration with President Trump and his Administration, more families across the United States can now access and benefit from IVF innovation and hopefully fulfill their dream of starting or expanding their family,” noting Gonal‑f’s usage leadership and over 6 million successful births worldwide supported by the portfolio.
Beyond price and access, EMD Serono plans to file Pergoveris for review under the FDA Commissioner’s National Priority Voucher (CNPV) program, which is designed to reduce review timelines from 10–12 months to 1–2 months for products aligned with national health priorities. If approved, Pergoveris would be the first and only U.S. combination of recombinant human FSH and LH, designed to mimic reproductive physiology and delivered via a prefilled Redi‑ject pen, potentially reducing injections, co‑pays, and self‑pay costs for combination therapy; the product is already available in 74 countries.
Contextually, EMD Serono positions itself as a leader in fertility therapeutics with science integral to the first IVF birth in the U.S., and it continues to offer therapeutic innovations, devices, technologies, and access services for families seeking to build or expand their families. With one in eight couples in the U.S. struggling to get pregnant and IVF being an important way to become parents, the mix of big discounts, a federal direct-to-consumer buying option, and a faster review process for a new combination therapy highlights a strategy to make treatment more affordable and provide more choices for patients.
The agreement’s implications include a potential reshaping of IVF drug pricing dynamics, expanded patient pathways through DTC channels, and accelerated regulatory timelines for combination stimulation protocols, contingent on FDA review outcomes; concurrent commitments on U.S. manufacturing investment tied to tariff exclusions may further anchor Merck’s fertility footprint domestically.
A new Ipsos survey commissioned by Fertility Matters Canada finds 49% of Canadians with an opinion support a national baseline for IVF funding support, with backing rising to 59% among those aged 18–34. One in eight Canadians say cost has already forced them or someone close to delay or abandon fertility treatment.
Alpha Controls & Instrumentation Inc. has been selected by FertiTech Canada Inc. as its third-party calibration partner for Nilotech temperature probes. The partnership channels Canadian IVF laboratories and fertility clinics using Nilotech equipment to Alpha Controls for professional, accredited calibration services, while FertiTech continues to handle equipment supply and gas sensor calibration.
In the UK, a Ten Minute Rule Bill has been introduced in the Commons to create a legal right to paid time off for fertility treatment, aiming to standardize access to time‑sensitive appointments and reduce reliance on employer discretion. The proposal seeks House permission to proceed and spotlights workplace rights during Fertility Awareness Week.
Columbia University Fertility Center has achieved the first confirmed pregnancy using an AI-guided sperm recovery method in a man with azoospermia, as detailed in The Lancet. The STAR system combined advanced imaging, microfluidics, and robotics to retrieve two viable sperm, enabling embryo creation after prior failed surgical and manual attempts.
British Columbia's free IVF program exhausts 2025 funding within months of launch. At least one approved clinic stops accepting new applications. Applicants face aging-out risks and must wait until spring 2026 for next funding allocation.
Singapore’s MOH approves 13 additional genetic conditions for testing before embryos are implanted during IVF, enhancing reproductive genetic screening options.
National Health Service-funded IVF in England varies across regions in terms of access, cycle definitions, and eligibility. While Integrated Care Boards follow NICE guidelines, local implementation differs to meet specific population needs. Current policy reviews aim to enhance consistency and ensure continued access to fertility services across England.
