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FDA Approves Temporary Drug Importation


In early 2023, cattle producers started reporting shortages of Folltropin, a follicle stimulating hormone (FSH) that induces superovulation in beef and dairy heifers and cows. According to reports from Vetoquinol USA, the drug’s manufacturer, the company had difficulties sourcing porcine pituitary glands and could not meet demand. By the end of the year, Folltropin was no longer available. 

Follitropin is the only FDA-approved drug for inducing superovulation in reproductively mature beef and dairy heifers and cows and is necessary for embryo transfer, so the industry had a significant problem.

After discussions with representatives from many animal groups, the Food and Drug Administration Center for Veterinary Medicine (FDA CVM) decided to temporarily allow the importation of Pluset, an unapproved animal drug used for inducing superovulation in cattle by veterinarians in other countries. Other groups involved included the American Veterinary Medical Association (AVMA), American Embryo Transfer Association (AETA), and the United States Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS),

Pluset

Pluset is an FSH and luteinizing hormone drug manufactured by Calier Spain and imported by Alberta Veterinary Laboratories/Solvet. While Pluset is used for the same purpose as Folltropin, the drug differs in composition and concentration of the active ingredients. Pluset hasn’t yet been evaluated or approved by the FDA, but the FDA is comfortable allowing temporary importation, because the drug is approved in Spain and several other countries and is subject to their regulatory standards, including adhering to acceptable manufacturing practices. 

Veterinarians and cattle producers who purchase the imported Pluset will receive a detailed information sheet that will include data on the drug, such as:

  • Pluset contains 500 IU of FSH and 500 IU of LH and is presented as a white to off-white lyophilized pellet and clear and colorless solution.
  • Potential adverse effects include slight reduction in milk yield, possible delayed return to heat, and ovarian cyst development.
  • Adverse drug effects should be reported to the prescribing veterinarian and Solvet or directly to the FDA through an online form.
  • Each vial should be reconstituted with 10.5 mls of solvent and administered intramuscularly.
  • The total recommended dose is 800 to 1000 IU in decreasing doses for four to five days. 
  • For heifers and beef cows, the total recommended dose is 800 IU. For dairy cows, the total dose can be increased to 1000 IU.
  • The withdrawal period is zero days for meat and offal and zero hours for milk.
  • Special storage instructions include:
    • The product should be stored unreconstituted below 77 degrees.
    • The reconstituted solution should be refrigerated, but not frozen.
    • Shelf life after reconstitution is six days.
  • Accidental self-injection may affect women hormonally and harm unborn children. 

Animal and Veterinary Innovation Agenda

The Folltropin shortage is one example of the FDA CVM’s reasons for initiating their Animal and Veterinary Innovation Agenda. Objectives include:

  • Supporting technologies and products that address high-priority needs — The FDA’s Veterinary Innovation Program assists sponsors and developers of FDA-regulated animal products originating from novel sources by encouraging development and research and guiding the regulatory process. They also assist product development innovation by providing advanced tools to address specific product development and regulatory needs, developing tests for detecting disease in animal cell or tissue based product (ACTP) donors, and using advanced computational tools to analyze complex genomic data.
  • Aligning regulatory pathways to the modern landscape — Actions include:
    • Creating a CVM Regulatory Modernization Task Force to review and recommend law and policy changes
    • Identifying potential process improvements, such as increasing review process efficiency
    • Implementing a questions-based review process to increase transparency regarding submission expectations
    • Providing customized templates to simplify applications for FDA approval for an animal product
  • Enhancing the One Health workforce — Actions include:
    • Convening a Genome Editing Regulatory Science Council to connect genome editing experts across the FDA’s human, animal, and plant regulatory programs
    • Creating a Scientific Recruitment Strike Team to recruit senior, high-impact technical and scientific leaders
    • Developing and implementing an FDA One Health Code of Practice
  • Identifying and addressing weaknesses — Identifying gaps in new technologies and emerging health threats and addressing weaknesses is critical. Actions include:
    • Monitoring emerging technologies across sectors, including biomedical products and novel food ingredients for humans and animals
    • Researching emerging technologies
    • Developing a clearly defined vision for CVM’s scientific and research goals
    • Ensuring experts across the agency can meet emerging human, animal, and environmental health threats

The FDA CVM is taking action to help prevent issues such as drug shortages and, hopefully, the steps will facilitate the ability to develop, produce, and distribute innovative, safe, and effective products.


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