Teresa Barnes knows on a deeply personal level the impact that a devastating rare disease can have on a family. Over the course of 10 years, she watched her father, aunt and three uncles die from an incurable lung disease called idiopathic pulmonary fibrosis.

IPF causes irreversible loss of lung function and impacts approximately 150,000 people in the United States. For patients, the lack of effective treatment options makes the need for new therapies especially urgent.

With family history being a risk factor for IPF, Teresa is concerned that her generation, as well as her teenaged daughter, may also face this disease.

Urgent need for rare disease innovation

Motivated by the need for faster progress in rare disease innovation and treatment options, Teresa is raising awareness about the FAIR Act (H.R. 7953), bipartisan legislation that was introduced in Congress in March. The FAIR Act would modernize how the U.S. Food and Drug Administration evaluates therapies for rare and life-threatening diseases.

More than 30 million Americans are living with a rare disease, yet the vast majority of them do not have an FDA-approved treatment. In some cases, Americans with rare diseases are waiting for access to clinical trials and treatments that are already available abroad.

A recent analysis of the FDA's "Novel Drug Approvals" annual reports showed that between 2018 and 2025, 119 novel drugs were first approved outside the U.S. before they received FDA approval. Of these drugs, approximately half were for rare diseases, known as orphan drugs. Additionally, significant delays can exist in bringing new treatments to the U.S., with U.S. drug approvals lagging ex-U.S. approvals by months and sometimes even years.

Giving rare disease patients a voice

"For people with a rare disease like IPF, these types of delays are unacceptable because many of our patients are dying three to five years after diagnosis," says Teresa, chief executive warrior at PF Warriors. "As a community, our greatest challenge is not just living with a rare disease. It's knowing that promising clinical trials and therapies may exist but remain out of reach."

If passed by Congress, the FAIR Act would create a streamlined pathway for the FDA to review and approve early-stage clinical trials and treatments that are already approved by trusted international regulators including the United Kingdom, European Union and Canada. At the same time, the FAIR Act would preserve the FDA's autonomy and safety standards.

"In IPF, 30% of Phase 2 clinical trials are being conducted outside the U.S. The FAIR Act echoes what our community has long known — we need faster access here in the U.S. to clinical trials and therapies that are available in other countries," says Teresa.

Supporting the FAIR Act

At the time of their passing, Teresa's family members did not have access to many of the scientific advances that researchers are pursuing today. The FAIR Act is designed to help ensure that medical advances abroad are made available to American patients more quickly while also encouraging biotechnology companies to increase their investment in U.S.-based clinical trials.

The legislation is gaining support from leading life sciences organizations and patient advocacy groups, which view it as a practical solution to ensure patients do not wait unnecessarily for potentially lifesaving therapies.

For patients and families affected by rare and life-threatening diseases, the FAIR Act represents an opportunity to close access gaps and provide hope.

For more information and to learn how to take action, visit FAIRActNow.com.