REGULATORY UPDATE: FDA Announces Shortages of Rho(D) Immune Globulin

The Food and Drug Administration recently issued information about current shortages of several products that are regulated by its Center for Biologics Evaluation and Research (CBER), some of which have relevance to the blood and biotherapies community.

Of particular note, FDA reported that there is currently a shortage of Rho(D) Immune Globulin. According to FDA, this shortage is caused by “a reduction of supply due to increase in demand.” 

AABB contacted Kedrion Biopharma Inc., a manufacturer of Rho(D) Immune Globulin. The company shared a letter it has sent to medical professionals and relevant organizations. “Due to various external factors beyond our control affecting the entire US anti-D plasma market, coupled with manufacturing deviations, we regret to inform you that we anticipate not having the usual supply to meet demand in 2024,” the letter stated. The company added that its “commitment to transparent communication and proactive resolution remains steadfast.”

Kedrion Biopharma’s response also noted that its supply of Rho(D) Immune Globulin is likely to “remain on allocation” for “the majority of 2024.” It added that the company is “diligently taking the necessary actions to expedite [its] return to full production capacity” and that although it will continue to send inventory to distributors, “quantities will be significantly reduced" and it “cannot guarantee product availability with the distributors.”