The following organizations have filed amicus curiae briefs or "friend of the court briefs" (parties who can show they have an interest in the outcome of the appeal) in the Franck's case at the 11th Circuit Court of Appeals.
1. Animal Health Institute filed a brief of amicus curiae supporting the United States position and reversal of the district court's decision.
2. The Generic Animal Drug Alliance filed a brief of amicus curiae supporting the United States' position and reversal of the district court's decision.
3. The Washington Legal Foundation filed a brief of amicus curiae supporting Franck's and the affirmance of the district court’s decision.
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Sunday, April 15, 2012
Saturday, April 14, 2012
Press Release issued by DOJ: U.S. Files Criminal Charges Against Dallas Company in Connection with Misbranded Drug Shipment That Led to Three Deaths
Department of Justice
Office of Public Affairs
FOR IMMEDIATE RELEASE
Friday, February 10, 2012
U.S. Files Criminal Charges Against Dallas Company in Connection with Misbranded Drug Shipment That Led to Three Deaths
The Justice Department, at the request of the Food and Drug Administration’s Office of Criminal Investigations (FDA-OCI), has charged Gary D. Osborn and his corporation, ApothéCure Inc., with two misdemeanor criminal violations of the Federal Food, Drug and Cosmetic Act (FDCA) in connection with their interstate shipment of two lots of misbranded colchicine injectable solution that led to the deaths of three people in the Pacific Northwest. The United States filed the criminal information in the U.S. District Court for the Northern District of Texas. ApothéCure is a compounding pharmacy. The company, founded in 1991, is located in Dallas.
Colchicine is used to prevent gout attacks (sudden, severe pain in one or more joints caused by abnormally high levels of a substance called uric acid in the blood) in adults, and to relieve the pain of gout attacks when they occur.
The government’s charges are based on ApothéCure’s February 2007 shipment of 72 vials of compounded colchicine to a now-defunct medical center in Portland, Ore. On March 19, 2007, a patient in Yakima, Wash., received colchicine from this shipment. That patient died after receiving the infusion. The medical examiner there determined that the cause of death was multiple organ failure and acute colchicine toxicity. On March 30, 2007, colchicine from ApothéCure was administered to two other patients who were suffering from back pain. Within hours of receiving the colchicine injections, both patients became seriously ill and were taken to local hospitals. Both patients died shortly thereafter. The medical examiner in Oregon determined colchicine toxicity to be the cause of death for both patients.
FDA testing of vials selected from the lethal shipment revealed that some of the vials were super-potent, containing 640 percent of the level of colchicine declared on the label. Other vials were determined to be sub-potent, and contained less than 62 percent of the declared levels on the labels.
“The criminal charges we are filing today allege that the drugs mixed by Mr. Osborn’s company were misbranded which led to the tragic deaths of three people,” said Tony West, Assistant Attorney General of the Civil Division of the Department of Justice. “We can’t allow those who fail to take care that their products are safe to escape accountability, and today's enforcement action demonstrates we won’t.”
The criminal information filed today charges that ApothéCure committed two prohibited acts under the FDCA by shipping misbranded drugs in interstate commerce. Mr. Osborn, as the person with responsibility over the firm’s operations, is strictly liable under the FDCA for the firm’s failure to follow federal law. In addition to the federal government’s criminal charges, Attorneys General have pursued civil actions in Texas and Oregon against Mr. Osborn and ApothéCure.
Assistant Attorney General West acknowledged the close partnership with the FDA and OCI, which referred this matter to the Justice Department. The case is being prosecuted by Trial Attorneys John Claud and Patrick Runkle of the Civil Division’s Consumer Protection Branch.
A criminal misdemeanor information is merely an allegation, and every defendant is presumed innocent until proven guilty beyond a reasonable doubt.
The Facts of the Franck's case
A veterinarian commissioned Franck's Compounding Lab, a Florida pharmacy, to compound an injectable solution of a prescription drug, Biodyl, which is not commericially available in the United States. The Biodyl was injected into horses on the Venezuelan Polo Team in 2009. After injected with the Biodyl, 21 horses died; five horses who did not receive the injection lived. The Florida Board of Pharmacy investigated and determined that a mathematical error--the misplacement of a decimal point-had made the solution of Biodyl deadly. The board believed that the mathematical error had nothing to do with preparing the compound from bulk materials. Although the Board fined and reprimanded Franck's, it allowed Franck's to continue its drug compounding business, which is approximately 40% of Franck's total business revenues.
After the Florida Board of Pharmacy closed its case, the Federal Drug Administration (FDA) began investigating Franck's. The FDA sent Franck's a "Form 483" notice containing five alleged violations-none of these involved claims of bulk compounding of animal drugs. A Form 483 notification is used for "Factory Inspections" to communicate "inspectional observations." The Form 483 notice requires a response. Franck's responded, arguing it had not violated federal law and asserting that compounding is regulated by the states rather than by the FDA or federal government. In April 2010, the FDA filed a civil complaint in federal district court and requested a permanent injunction prohibiting Franck's from compounding animal medications. See Memorandum of Law in Support of Plaintiff's Preliminary Injunction On September 12, 2011, United States District Court Judge Timothy J. Corrigan issued an 80-page opinion, deciding in favor of Franck's, granting its motion for summary judgment and denying the FDA's request for an injunction.
The FDA appealed the district court's decision to the Eleventh Circuit Court of Appeals. The Department of Justice (DOJ), who represents the FDA, has filed its brief in case number 11-15350. Franck's has filed its response brief. DOJ's reply to Franck's brief is due now due on May 1, 2012, after they received an extension of time to file.
After the Florida Board of Pharmacy closed its case, the Federal Drug Administration (FDA) began investigating Franck's. The FDA sent Franck's a "Form 483" notice containing five alleged violations-none of these involved claims of bulk compounding of animal drugs. A Form 483 notification is used for "Factory Inspections" to communicate "inspectional observations." The Form 483 notice requires a response. Franck's responded, arguing it had not violated federal law and asserting that compounding is regulated by the states rather than by the FDA or federal government. In April 2010, the FDA filed a civil complaint in federal district court and requested a permanent injunction prohibiting Franck's from compounding animal medications. See Memorandum of Law in Support of Plaintiff's Preliminary Injunction On September 12, 2011, United States District Court Judge Timothy J. Corrigan issued an 80-page opinion, deciding in favor of Franck's, granting its motion for summary judgment and denying the FDA's request for an injunction.
The FDA appealed the district court's decision to the Eleventh Circuit Court of Appeals. The Department of Justice (DOJ), who represents the FDA, has filed its brief in case number 11-15350. Franck's has filed its response brief. DOJ's reply to Franck's brief is due now due on May 1, 2012, after they received an extension of time to file.
Friday, April 13, 2012
What Is Considered a Compounded Drug?
When your child does not like the taste of the antibiotic the doctor prescribes and the pharmacist adds a flavor to the medication, the result is a compounded drug. When a commercial drug is available only in tablet form for your pet, but a liquid version of the medication is needed, prepared and provided to you for your animal, the result is a compounded drug.
Compound preparations for both humans and animals have existed for years. See United States v. Bader, slip opinion, *2-3, n.1 (Colo. July 23, 2009) Compound preparations accounts for some 30 million prescriptions a year in the United States and are a huge money-making business. Compounding is the only source for some medications. Today, compounding of drugs is “a traditional component of the practice of pharmacy, and is taught as part of the standard curriculum at most pharmacy schools.” Thompson v. W. States Med. Ctr., 535 U.S. 357, 361 (2002)(internal citations omitted).
Despite the long history and tradition of compound drugs, the Federal Drug Administration (FDA) does not have a formal definition of compounded drugs in its regulations. Instead, Congress defined what is not compounding in the Food and Drug Administration Modernization Act of 1997, which amended 21 U.S.C. § 353A, as follows:
``(f) Definition.--As used in this section, the term `compounding' does not include mixing, reconstituting, or other such acts that are performed in accordance with directions contained in approved labeling provided by the product's manufacturer and other manufacturer directions consistent with that labeling.''.
The ability to customize preparation of a medicine that is not available from major drug makers is necessary for obvious reasons. The issue is when does this customize preparation of a medicine cross over from mere compounding and become manufacturing of a drug. This area of law is opaque and fluctuating and in much need of more developed laws, rules, regulations and especially guidance to those who prescribe and prepare compound drugs.
Compound preparations for both humans and animals have existed for years. See United States v. Bader, slip opinion, *2-3, n.1 (Colo. July 23, 2009) Compound preparations accounts for some 30 million prescriptions a year in the United States and are a huge money-making business. Compounding is the only source for some medications. Today, compounding of drugs is “a traditional component of the practice of pharmacy, and is taught as part of the standard curriculum at most pharmacy schools.” Thompson v. W. States Med. Ctr., 535 U.S. 357, 361 (2002)(internal citations omitted).
Despite the long history and tradition of compound drugs, the Federal Drug Administration (FDA) does not have a formal definition of compounded drugs in its regulations. Instead, Congress defined what is not compounding in the Food and Drug Administration Modernization Act of 1997, which amended 21 U.S.C. § 353A, as follows:
The ability to customize preparation of a medicine that is not available from major drug makers is necessary for obvious reasons. The issue is when does this customize preparation of a medicine cross over from mere compounding and become manufacturing of a drug. This area of law is opaque and fluctuating and in much need of more developed laws, rules, regulations and especially guidance to those who prescribe and prepare compound drugs.
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