Stephen F Sundlof, D.V.M., Ph.D. Director of the Center for Veterinary Medicine Food and Drug Administration 240-276-9000 phone 240-276-9001 fax [email protected] Dr. Marcia Larkins Ombudsman, Center for Veterinary Medicine 240-276-9015 phone 240-276-9060 fax [email protected] Virginia Behr FDA - Ombudsman Phone 301-796-0675 Fax 301-796-9883 [email protected] Andrew von Eschenbach FDA Commissioner phone 301-827-2410 Fax 301-443-3100 [email protected] To Whom It May Concern, We are aware that there has been a voluntary removal of pergolide mesylate from the human drug market in the United States. We are writing to let you know that there are many thousands of horses that rely on pergolide mesylate as treatment for Equine Pituitary Pars Intermedia Dysfunction (Equine Cushings Disease). Currently, it is the most effective treatment available for this condition, and contributes greatly to the health of thousands of affected horses annually. Many of the horses are receiving the pergolide in a compounded dosage form. There are an estimated 10+ million horses in this country, approximately 10% of which are age 20 or above. If only 1% of those are on treatment for Cushing\'s disease, an ultraconservative estimate, that\'s still 10,000 horses in need of access to pergolide mesylate; if 10%, that\'s 100,000 horses. Time is running out for these horses. We urge the FDA to immediately publish an exception to the prohibition on compounding from bulk drug with specific reference to horses with Cushing\'s Disease as at least an interim solution. To allow even one horse to suffer needlessly is an outrage. Sincerely,