EMD Serono Partners with U.S. Government to Expand Access to IVF Therapies for Millions of Americans
EMD Serono, the healthcare division of Merck KGaA, Darmstadt, Germany, operating in the United States and Canada, has announced a groundbreaking agreement with the U.S. government, under the administration of President Donald J. Trump, to significantly expand access to its portfolio of in vitro fertilization (IVF) therapies. This initiative is aimed at supporting the more than 10 million American women struggling with infertility and seeking effective reproductive solutions.
The agreement highlights a unique public-private partnership designed to increase affordability, accessibility, and awareness of assisted reproductive technologies (ART), including therapies that have already helped millions of families worldwide. By leveraging both government initiatives and EMD Serono’s expertise, this collaboration represents a transformative step in addressing the financial and logistical barriers to fertility care.
Direct-to-Consumer Access at Reduced Prices
As part of the agreement, EMD Serono will offer Direct-to-Consumer (DTC) sales of its full portfolio of IVF therapies to eligible patients holding prescriptions, providing treatments at substantially reduced prices. The company’s IVF portfolio includes:
- Gonal-f® (follitropin alfa injection)
- Ovidrel® (choriogonadotropin alfa injection)
- Cetrotide® (cetrorelix acetate for injection)
When used together in a standard IVF protocol, patients will receive an 84% discount off list prices, significantly lowering the cost of treatment and reducing financial burdens for those seeking fertility care.
These therapies will be available through TrumpRx.gov, a direct purchasing platform scheduled to launch in January 2026, and will complement existing pharmacy networks. The expanded network ensures continued patient access while offering additional channels for affordable therapy distribution.
This initiative aligns with the White House Executive Order on expanding affordable access to IVF treatments, marking the first coordinated effort of its kind to make fertility therapies widely accessible in the United States. President Trump and members of his administration held a special Fertility event at the White House to recognize the agreement and confirm that EMD Serono voluntarily fulfilled all requirements outlined in the Executive Order.
Support for Domestic Biopharmaceutical Manufacturing
In addition to expanding access to IVF therapies, EMD Serono has entered a separate agreement with the U.S. Secretary of Commerce to exclude its pharmaceutical products and ingredients from Section 232 tariffs, contingent upon investment in future biopharmaceutical manufacturing and research within the United States.
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,” said Belén Garijo, Chair of the Executive Board and CEO of Merck KGaA, Darmstadt, Germany. “We look forward to growing our footprint here even further with future fertility manufacturing. We are committed to adding long-term value for patients and customers while continuing to innovate in reproductive health.
This agreement underscores EMD Serono’s dual commitment to enhancing patient access and supporting domestic innovation, reinforcing the company’s role as a leader in fertility therapeutics.
Expanding Therapeutic Options with Pergoveris®
To further strengthen treatment options for women with complex fertility challenges, EMD Serono plans to submit Pergoveris® for review under the FDA Commissioner’s National Priority Voucher (CNPV) program. This FDA initiative is designed to expedite the review of therapies aligned with national health priorities, reducing typical review times from 10–12 months to just 1–2 months.
Pergoveris combines recombinant human follicle stimulating hormone (r-hFSH) and recombinant human luteinizing hormone (r-hLH) in a single pre-filled injection using the Redi-ject® pen technology, already proven with Gonal-f. The combination therapy is designed to:
- Mimic natural reproductive physiology
- Support follicular development up to ovulation and maturation
- Reduce the number of injections required during treatment
- Improve patient convenience and potentially reduce overall costs
Currently available in 74 countries worldwide, Pergoveris could become the first and only combination therapy of r-hFSH and r-hLH approved in the United States, offering a new, physiologically optimized approach to ovarian stimulation for medically assisted reproductive cycles.
As a result of our collaboration with President Trump and his administration, more families across the United States can now access IVF innovations and pursue their dream of parenthood,” said Danny Bar-Zohar, CEO Healthcare and Member of the Executive Board of Merck KGaA, Darmstadt, Germany. “Gonal-f is the most prescribed follicle stimulating hormone in the U.S., and our IVF portfolio has already contributed to over 6 million successful births worldwide. We are excited to expand options further through the FDA review of Pergoveris under the CNPV program.
Impact on Infertility Care in the United States
Infertility affects approximately 1 in 8 couples in the U.S., making IVF a critical treatment option for many men and women. Despite its effectiveness, access to fertility therapies has often been limited by high costs, geographic disparities, and insurance coverage gaps.
By reducing costs and increasing availability, EMD Serono and the U.S. government aim to democratize access to IVF and ensure patients in both urban and rural areas can benefit from state-of-the-art fertility treatments. In addition, expanded provider training and public awareness campaigns are expected to improve patient experiences and treatment outcomes.
Through this collaboration, EMD Serono demonstrates its commitment to patient-centered care, integrating cutting-edge science, innovative delivery technologies, and supportive programs to enhance the IVF journey for patients nationwide.
The agreement between EMD Serono and the U.S. government represents a major step forward in reproductive health, offering millions of Americans more affordable and accessible IVF treatment options. By combining financial support, technological innovation, and regulatory collaboration, this initiative sets a new standard for public-private partnerships in fertility care.
As EMD Serono continues to expand its portfolio, invest in domestic manufacturing, and advance therapies like Pergoveris, the company reaffirms its position as a global leader in fertility therapeutics, committed to helping families achieve their dreams of parenthood while driving innovation in reproductive medicine.
