Gary D. Osborn's Plea in Criminal Case

Today, a magistrate judge in the Northern District of Texas recommended that the district court accept Gary D. Osborn's guilty plea to a two-count information, charging violations of  21 U.S.C. Section 331(a), 352(a) and 333(a)(1)--all criminal, class A misdemeanors--for introducing in interstate commerce a misbranded drug in that its label was false and misleading. Click here to see Report and Recommendation of magistrate judge.  As noted in previous blogs three people died because of misbranded colchicine injectable solution compounded at ApothéCure, Inc., where Osborn was a pharmacist.  Osborn was released on conditions that are typical of this type of case.  The next step is that the district court will most likely accept the magistrate judge's report and recommendation, thus accepting Osborn's guilty plea and then impose sentence.

Readers feel free to comment on whether pharmacists and companies that compound medications should be held criminally responsible in these types of cases?  Should criminal charges be brought only in cases where death or serious bodily injury results?  Does it matter if the death or serious bodily injury is that of an animal instead of a human?  Should a company be shut down if a death or serious bodily injury results?

Plea Hearing in ApothéCure and Gary D. Osborn Criminal Case

A hearing in the criminal case of ApotheCure and Gary D. Osborn is scheduled for 10:30 a.m. today.  It is expected that ApothCure and Gary D. Osborn will plead guilty to the two-count information, charging violations of  21 U.S.C. Section 331(a), 352(a) and 333(a)(1)--all criminal, class A misdemeanors--for introducing in interstate commerce a misbranded drug in that its label was false and misleading. The defendants were responsible for introducing into interstate commerce two lots of misbranded colchicine injectable solution that led to the deaths of three people in the Pacific Northwest.  Updates on the hearing will be posted as soon as the information is available.

India No Longer Making Cisapride

Cisapride, while banned for use in humans, is a commonly used and valuable drug used for animals.  The country of India previously made Cisapride; however, their government has shut down production for human safety reasons.  Several organizations have petitioned the Indian government to reconsider.  Here is the letter that the Society of Veterinary Hospital Pharmacists wrote to the Indian government petitioning them to reconsider.  Click here.


Special thanks to Gigi S. Davidson for bringing this issue to the author's attention. 

FDA Video About Compounding

The United States Food and Drug Administration has prepared a video explaining compounding to consumers.  To view this video, click here.

FDA Statement on Compounding of Pergolide Products for Animal Use

March 16, 2012
On September 7, 2011, the U.S. Food and Drug Administration (FDA or Agency) approved a new animal drug application (NADA) for a product containing pergolide mesylate (NADA 141-331) marketed under the trade name PRASCEND Tablets for the control of the clinical signs associated with Cushing’s Disease in horses.
In the past, veterinarians prescribed human pergolide products to treat Cushing’s Disease in horses under the “extralabel” use provisions of the Federal Food, Drug, and Cosmetic Act. However, in May 2007, the human pergolide products were removed from the market due to concerns about cardiac side effects in humans. At that time FDA stated that it would work with the sponsors of approved human products and others to ensure that pergolide remained available to treat Cushing’s Syndrome in horses until a new animal drug application was approved for that use. FDA stated that this would include, among other things, exercising enforcement discretion as appropriate over the pharmacy compounding of pergolide for use in animals. However, because FDA has approved NADA 141-331, the conditions under which the Agency was exercising enforcement discretion no longer exist.


For additional information, click here.