Facing shortage, FDA CVM allows temporary imports of non-FDA approved drug for cattle

Updated February 06, 2024

A national shortage of the only Food and Drug Administration (FDA)–approved drug for inducing superovulation in cattle has prompted the FDA’s Center for Veterinary Medicine (FDA CVM) to take action. The agency announced January 31 that it would temporarily allow the importation of an unapproved animal drug used for the same bovine reproductive purposes in other countries.

Due to a shortage of Folltropin, an FDA-approved pig pituitary–derived follicle stimulating hormone (FSH), the agency will not object to the temporary importation of Pluset, which is manufactured by Calier Spain and imported by Alberta Veterinary Laboratories/Solvet. Pluset is an FSH and lutenizing hormone drug approved for use in Spain and other countries.

Folltropin is the only animal product approved by the FDA CVM for inducing superovulation in reproductively mature beef and dairy heifers and cows.

Pregnant cow
Cattle producers began reporting shortages of Folltropin, an animal drug used for bovine reproductive purposes, in early 2023. Supplies of the drug have since run out, prompting action by the Food and Drug Administration to help find an alternative.

“This drug is critical for the embryo transfer industry,” said Dr. Fred Gingrich, executive director of the American Association of Bovine Practitioners (AABP).

Since no approved alternatives to Folltropin are commercially available in the United States, supply chain disruptions limiting the drug’s availability have significant negative impacts on cattle producers and veterinarians, he added.

“For some cattle veterinarians, embryo transfer and advanced reproductive technologies are a significant part of their practice—and sometimes the only part of their practice,” Dr. Gingrich said.

“Folltropin and Pluset are used for the same purpose, however, the composition and concentration of the active ingredients are different, as are the doses and dosage regimens,” the FDA CVM said in its announcement. “When imported Pluset is distributed in the U.S., it will be accompanied by a client information sheet for veterinarians and cattle producers with detailed information explaining how to use Pluset.”

The agency continued: “Although the imported Pluset product has not been evaluated or approved by the FDA, it is approved in Spain, the country of origin, and several other countries, and is subject to those countries’ regulatory standards, including adherence to good manufacturing practices.”

Cattle producers began reporting shortages of Folltropin in early 2023. By year’s end, supplies of the drug had run out. Manufacturer Vetoquinol USA reportedly had been experiencing difficulties sourcing porcine pituitary glands.

As the shortage dragged on, the AVMA, AABP, and American Embryo Transfer Association discussed possible solutions with FDA CVM officials, as well as representatives of the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS), which regulates importation of animal-derived products, among other things.

Following the FDA CVM announcement, Dr. Lindsey Hornickel, an assistant director in the AVMA’s Washington, D.C., office, thanked the FDA and USDA for working with stakeholders and their flexibility in meeting this important market need.

“This animal drug shortage is an example of some of the challenges the FDA CVM wants to address with its Innovation Agenda,” Dr. Hornickel said. “We’re hopeful that as FDA CVM moves forward with its agenda, these types of shortage situations become less and less common.”