Years of Advocacy Pay Off With Policy Change That Improves Science and Protects Horseshoe Crabs

WASHINGTON, D.C.— The Physicians Committee for Responsible Medicine, a nonprofit working for effective, efficient, and ethical medical research, testing, and training, is thrilled to acknowledge a significant policy change by the U.S. Pharmacopeia, the organization responsible for setting national safety standards used in medical product manufacturing. This exciting development promises to greatly benefit horseshoe crabs, whose blood has been used in testing for the safety of injectables, including medications and vaccines, due to its ability to detect dangerous contaminants.

For nearly half a billion years, horseshoe crabs have survived multiple mass extinctions and numerous threats to their existence. In recent years, however, they have faced a new challenge: a needle to the heart to obtain their blood, which contains a component used in endotoxin testing.

Today’s policy change marks a pivotal shift toward using lab-produced, nonanimal approaches instead. These methods, known collectively as recombinant Bacterial Endotoxins Tests (rBET), are not only more humane but also offer greater reliability and consistency compared to traditional blood-based tests. Synthetic versions allow scientists to avoid the false positives associated with blood-based endotoxin tests and help to ensure a stable supply chain by avoiding reliance on the blood of wild animals that are subject to environmental pressures.

For years, the Physicians Committee has advocated for this policy change, conducting roundtables, workshops, and training sessions, contributing to the scientific literature, and engaging with leaders in Congress like U.S. Rep. Frank Pallone (D-NJ) and Sen. Cory Booker (D-NJ), for the adoption of nonanimal testing methods. The new policy allows for the use of nonanimal approaches, a development that many companies have been eagerly anticipating.

“Regulatory uncertainty and familiarity often drive decision-making in favor of more traditional test methods, despite the availability of modern approaches that offer advantages,” said Elizabeth Baker, director of regulatory policy at the Physicians Committee. “The USP's action today recognizes nonanimal approaches as safe, equivalent options. With this change, companies can confidently choose nonanimal options for endotoxin testing.”

"I fully support U.S. Pharmacopeia's new guidelines for synthetic alternatives to horseshoe crab blood for biomedical testing,” said U.S. Congressman Frank Pallone, Jr. (D-NJ). “For years, I’ve been leading the charge in Congress to track horseshoe crabs, study coastal ecosystems, and modernize our biomedical testing guidelines. Synthetic alternatives offer a viable solution to get these ancient creatures out of the biomedical supply chain and keep them in their natural habitats.”

This policy change better aligns with changes already made in Europe, and the FDA has already accepted rBET methods for several marketed products, after Eli Lilly, a leader in advancing the science and acceptance of rBET, worked with the agency on a case-by-case basis.

Momentum for this change has been building for some time, and many at the USP, in private industry, government, and even a coalition dedicated to saving horseshoe crabs, have played an important role in this achievement. Notably, last week, several companies that sell both blood-based and rBET methods joined together in recognizing the benefits of an industry transition from animal-based tests to the nonanimal alternatives.

While this achievement is a major step forward, the Physicians Committee remains dedicated to ongoing efforts to eliminate all uses of horseshoe crabs in testing.

To speak with Elizabeth Baker, please contact Reina Pohl at 202-527-7326 or rpohl [at] pcrm.org (rpohl[at]pcrm[dot]org).