Judge grants Cardinal Health temporary restraining order against DEA
DUBLIN, Ohio — Cardinal Health was granted a temporary restraining order Friday against the Drug Enforcement Administration’s suspension order of its Lakeland, Fla., distribution center.
A preliminary injunction hearing is currently scheduled for Feb. 13.
The move came after the DEA suspended registration of the Lakeland facility to distribute controlled medicines to pharmacy customers in Florida, Georgia and South Carolina. According to Cardinal Health, DEA took this action after alleging that some of the prescriptions filled at four of the 2,500 pharmacies served out of that facility were not written for legitimate medical reasons.
"I will point out here that, at the time we filled these orders, the pharmacies held valid state board of pharmacy and DEA licenses," Cardinal Health chairman and CEO George Barrett said. "We are outraged that the DEA took this action."
"Friday’s operation at the Lakeland facility is not DEA’s first visit," the DEA stated in a release issued Monday. "In December 2007, DEA issued an Immediate Suspension Order at the location due to its distribution of hydrocodone to ‘rogue’ internet pharmacies." That action, and similar actions at other Cardinal Health facilities across the United States, resulted in a $34 million fine, the DEA added.
The DEA also suspended the registration of two CVS/pharmacy locations in Sanford, Fla. in the same action. The DEA alleged the two CVS/pharmacy locations, located 5.5 miles apart, were filling oxycodone prescriptions far in excess of what a typical pharmacy dispenses.
Cardinal Health and the two CVS/pharmacy locations will be given an opportunity for an administrative hearing to determine whether the DEA Certificate of Registration at each of the three locations should be revoked. The final decision will be published in the Federal Register, the DEA stated.
The order from the U.S. District Court for the District of Columbia is available here.
FDA approves Vyvanse for adults with ADHD
PHILADELPHIA — The Food and Drug Administration has approved a drug made by Shire for attention deficit hyperactivity disorder, the company said Tuesday.
Shire announced the FDA approval of Vyvanse (lisdexamfetamine dimesylate) capsules as a maintenance treatment for adults with ADHD. The drug already was approved for use in children and was approved for treating ADHD in adults in 2008.
The company said the approval was based on a clinical trial that showed more ADHD patients controlling their symptoms with Vyvanse than with placebo.
Reps. seek sponsors for MTM bill
NEW YORK — Two members of Congress are looking for co-sponsors for a bill that would strengthen the medication therapy management benefit in the Medicare prescription drug program.
Last year, Rep. Mike Ross, D-Ala.; and Cathy McMorris Rodgers, R-Wash., introduced H.R. 891, the Medication Therapy Management Benefits Act, which would allow elderly people with at least one chronic condition access to Medicare Part D coverage for MTM. Currently, only those with multiple conditions are eligible.
In late January, Ross and Rodgers sent a letter to other members of the House of Representatives seeking co-sponsors for the bill. "There is significant evidence that MTM improves care and saves money," the two wrote, mentioning that CareFirst BlueCross BlueShield of Maryland found in a study last year that for every dollar spent on MTM, $10 was saved in avoided healthcare costs.
The letter drew praise from the National Association of Chain Drug Stores. "Pharmacist-administered MTM services allow a clinically trained pharmacist to conduct one-to-one counseling sessions with patients to help ensure the best combinations of medicines are taken properly," NACDS president and CEO Steve Anderson said. "MTM is just one of many services provided by pharmacists that demonstrate the unsurpassed value of community pharmacy. These services can improve health and reduce healthcare costs across the board."