Nineteen Grants and Two Contracts Grab $38 Million In Support From the FDA

The United States Food and Drug Administration (FDA) announced on October 17 their awarding of over $38 million split between nineteen new grants and two contracts. These funds will support clinical trials, natural history studies, and regulatory science tools centered on rare diseases like Amyotrophic Lateral Sclerosis (ALS).

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$38 Million More Fighting Against Rare Diseases

Since 1983, the FDA’s Orphan Products Grants Program has funded numerous clinical programs investigating the development of safe and effective medical products for rare diseases. These clinical trials have resulted in over eighty products. 

Starting in 2016, the FDA began funding natural history studies as well in order to better understand rare diseases. Because of their infrequency, there is a lack of understanding of rare diseases’ presentation, significant limitations on day-to-day function, core unmet needs, and course. As a result, drug development for these maladies is made all the more difficult. 

Of the thirty-three clinical trial grant applications, eleven received more than $25 million in support spread out over the next four years. Studies centered around rare forms of cancer dominated a majority of these chosen studies, totaling seven. 

Though the FDA received more than forty-three natural studies grant applications, only eight received approval. Similarly to the approved clinical trial grants, the FDA doled out more than $11 million spread over the next four years. 

On the FDA grants, Sandra Retzky, D.O., J.D., MPH, director of the FDA’s Office of Orphan Products Development (OOPD), said, “These grants provide important funding to researchers who are working to develop better treatments for rare disease patients.”

The FDA also granted funding to two contracts centered on rare neurodegenerative diseases. The first studies whether a physical assessment of ALS patients can be conducted remotely as opposed to the traditional setting of a doctor’s office. Co-funded by the National Institutes of Health (NIH), the study has the potential to result in the decentralization of clinical trials, opening access to patients in remote locations. 

The second contract analyses patient preference information (PPI) studies focused on brain-computer interface (BCI) devices, specifically on their use on patients unable to speak or move. This study alone garnered almost $6 million in support from the FDA and its partners. 

Retzky went on to say about the contracts, “The contracts aim to advance treatment options for patients, help inform regulatory decision making, and promote diversity, equity and inclusion in clinical research. OOPD will continue to make investments in progressive studies to advance medical product development.”

Author

Max Heirich