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.