Additional Amicus Curiae Briefs filed in the Franck's case

Additional Amicus Curiae Briefs have been filed in the Franck's case.  Both briefs support the affirmance of the district court decision:

1.  Society of Veterinary Hospital Pharmacists

2.  Former FDA Officials

See Previous Blog Entry

ApothéCure and Gary D. Osborn Criminal Case: Hearing Set

A Rearraignment/Guilty Plea hearing has been set in the ApothéCure and Gary D. Osborn criminal case for April 24, 2012, at 10:30 in the Northern District of Texas.  See Notice filed by district court.  Most likely with the filing of a criminal information, instead of the grand jury issuing an indictment,  and this notice of rearraignment, a plea agreement has been reached between the parties and at the rearraignment the defendants will enter a plea of guilty.


Prior State Proceedings:


  In November 2010, the Texas state board reprimanded Osborn's pharmacist license of Osborn because he had failed to ensure that an error did not occur during the making of that compounded sterile preparation of colchicine.  The Texas state board fined ApothéCure $125,000 and its license was placed on probation for one year with the condition that the pharmacy develop and implement a continuous quality improvement program for preventing and handling dispensing errors.

Declarations Filed in Franck's district court proceeding

In the appeal to the 11th Circuit in the Franck's case, the court, pursuant to the federal appellate rules, is normally only allowed to consider what was part of the record in the district court. In other words, the appellate court cannot consider evidence or information that was not presented in the district court.  In the district court, the parties filed a number of declarations or sworn statements by various individuals, including the following:

Declaration of Loyd V. Allen, Jr.

Declaration of Shelton T. Bradshaw

Declaration of  Gigi S. Davidson

Declaration of William T. Flynn

Declaration of Paul W. Franck

    Supplemental Declaration of Paul W. Franck

Declaration of Rick Pelphrey

Declaration of Kenneth Pettengill

Declaration of James B. Powers

Declaration of Dr. Robert C. Saunders

Declaration of Emma Singleton

Declaration of Kevin Stoothoff

Because these declarations were all apart of the record in the district court, they are part of the record on appeal and can be considered by the appellate court.

Criminal Charges in a Compounding Case: Exercise of Federal Authority

The Criminal Information filed against ApothéCure, a major compounder in the United States, and Gary D. Osborn charges violations of 21 U.S.C. Section 331(a), 352(a) and 333(a)(1)--all criminal, class A misdemeanors.  Basically, the information charges that  ApothéCure and Gary D. Osborn introduced in interstate commerce a misbranded drug in that its label was false and misleading.  Criminal misdemeanors under the federal system are criminal offenses eligible for terms of imprisonment that do not exceed one year but are more than six months in length by federal statute. See 18 U.S.C. 3559(a)(6)  Under the federal system, the district court also uses the advisory United States Sentencing Guidelines to determine the range and actual punishment.  Both the criminal charges in ApothéCure and the attempt to obtain an injunction in Franck's show the FDA and DOJ attempting to exercise its federal jurisdiction to regulate and punish compounders who step out of bounds.  It will be interesting to see how far the federal courts allow the FDA and DOJ  to exercise this power against other compounders who violate the law.   The appeal  in Franck's while only binding on those states in the 11th Circuit Court of Appeals--Alabama, Florida, and Georgia--will be precedent setting with the possibility, no matter the outcome, of making its way to the United States Supreme Court.  The other possibility if DOJ/FDA loses the appeal is for there to be a legislative fix attempting to define the parameters of federal jurisdiction to regulate this area of the law.