EMD Serono, the healthcare business of Merck KGaA, Darmstadt, Germany, operating in the U.S. and Canada, has announced a landmark agreement with the administration of President Donald J. Trump to broaden access to in vitro fertilization (IVF) therapies for the more than 10 million American women and couples struggling with infertility. The initiative marks a first-of-its-kind public-private collaboration aimed at making fertility care more affordable and accessible across the United States.
As part of this agreement, EMD Serono will offer Direct-to-Consumer (DTC) sales of its comprehensive IVF portfolio, including Gonal-f® (follitropin alfa injection), Ovidrel® (choriogonadotropin alfa injection), and Cetrotide® (cetrorelix acetate for injection), to eligible patients with prescriptions at significantly reduced prices. When all three therapies are used in a typical IVF protocol, patients will benefit from an 84% discount off list prices, substantially lowering the financial burden associated with fertility treatment.
The therapies will also be made available through TrumpRx.gov, a direct purchasing platform scheduled to go live in January 2026. Patients will retain access to EMD Serono’s full portfolio of fertility medicines via the company’s existing pharmacy network, as well as an expanded network coinciding with the launch of the new platform. This collaboration aligns fully with the White House Executive Order aimed at increasing affordable access to IVF treatments. President Trump and key members of his administration hosted a special Fertility event at the White House to highlight that EMD Serono voluntarily met all the directives outlined in the Executive Order.
In addition to expanding patient access, EMD Serono entered an agreement with the U.S. Secretary of Commerce to exclude its pharmaceutical products and active ingredients from Section 232 tariffs, contingent upon the company investing in future biopharmaceutical manufacturing and research within the United States. This arrangement underscores a commitment to supporting domestic production, innovation, and job creation in the biopharmaceutical sector.
Reflecting on the announcement, Belén Garijo, Chair of the Executive Board and CEO of Merck KGaA, Darmstadt, Germany, stated:
“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. We are committed to working with the U.S. administration to add long-term value, ensuring that our patients and customers continue to have access to and benefit from the innovations within our portfolio.”
To further enhance therapeutic options for patients with complex fertility needs, EMD Serono plans to submit Pergoveris® for review under the FDA Commissioner’s National Priority Voucher (CNPV) program. The CNPV program is an FDA initiative designed to expedite the review of drugs that meet critical U.S. national health priorities, reducing the typical review period from 10-12 months to just 1-2 months. Pergoveris has been identified as meeting all criteria under this program, paving the way for potentially rapid FDA approval.
Pergoveris represents a novel therapeutic approach for women undergoing ovarian stimulation for Medically Assisted Reproductive (MAR) cycles. If approved in the U.S., it would become the first and only combination of recombinant human follicle stimulating hormone (r-hFSH) and recombinant human luteinizing hormone (r-hLH) available. The therapy is specifically designed to mimic natural reproductive physiology, with r-hFSH and r-hLH acting synergistically to support follicular development, ovulation, and maturation.
In addition, Pergoveris offers a combination protocol in a single pre-filled Redi-ject® pen, a delivery system previously validated with Gonal-f. This technology allows for fewer injections, a potentially improved patient experience, lower out-of-pocket costs, and a reduced financial burden for combination therapy, making it a practical solution for patients navigating complex fertility regimens. Pergoveris is already available in 74 countries worldwide, underscoring its global acceptance and safety profile.
Commenting on the broader impact of the initiative, Danny Bar-Zohar, CEO Healthcare and Member of the Executive Board of Merck KGaA, Darmstadt, Germany, said:
“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. Gonal-f is the most prescribed follicle stimulating hormone in the U.S., and our full portfolio of IVF therapies has supported over six million successful births worldwide. Looking forward, we will continue to address complex fertility issues for patients in the U.S. with the FDA filing of Pergoveris through the Commissioner’s National Priority Voucher program.”
Infertility affects approximately one in eight couples in the United States, making IVF a critical treatment option for many men and women. As the leader in fertility therapeutics, EMD Serono has played a pivotal role in advancing reproductive science, including contributing to the birth of the first IVF baby in the U.S. today. Beyond therapeutic innovation, the company provides devices, technologies, and access services designed to help families navigate the challenges of assisted reproduction and realize their goal of having a child.
Through this public-private partnership, EMD Serono demonstrates a strong commitment to reducing financial barriers, enhancing patient access to life-changing fertility therapies, and supporting domestic biopharmaceutical innovation. By combining affordability initiatives, expanded distribution, and accelerated regulatory pathways for innovative therapies like Pergoveris, the company positions itself at the forefront of the fertility landscape in the U.S.
Looking ahead, EMD Serono aims to continue expanding therapeutic options, invest in U.S.-based research and manufacturing, and collaborate closely with healthcare policymakers to ensure that patients receive timely, effective, and affordable IVF treatments. This landmark agreement not only addresses an urgent healthcare need but also reflects the potential of strategic partnerships between private industry and government to deliver meaningful benefits to patients nationwide.
