From Capitol Health Record:  By the end of June, it is expected the Supreme Court will rule on the constitutionality of the Patient Protection and Affordable Care Act. Join us to gain a better understanding of the four questions before the Court and the political, legislative and regulatory implications of the Court’s pending decisions. Our panel also will discuss the different possible outcomes of the Court’s deliberations and their respective political and policy ramifications. Regardless of where you work or who you represent, this presentation will provide important insight and analysis to help inform your business, association, legislative and/or regulatory planning.

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Fox Trial Finder is a welcomed initiative in ongoing efforts to facilitate clinical trial participation.  In a recent interview with ABC’s Diane Sawyer, Michael J. Fox, who suffers from Parkinson’s disease, said that in addition to his support for stem cell research addressing Parkinson’s, he also supports research looking for a cure on other fronts, including drug therapies and diagnostic tests. (Article Link)  Toward that end, Fox’s Foundation for Parkinson’s Research recently launched an online initiative called Fox Trial Finder.  This website promotes research across the country by pairing patients with clinical trials in their areas, based on the individual’s symptom profile.  The foundation’s webpage notes that 30% of all clinical trials fail to recruit even one subject, and that 85% of clinical trials are delayed because of insufficient subject enrollment – so Fox’s initiative (and others like it that … Read More »

On May 17, 2012, Osiris Therapeutics announced that Canadian health regulators approved Prochymal, its drug for acute graft-versus host disease in children who have failed to respond to steroid treatment. Prochymal is the first stem cell drug to be approved anywhere in the world for a systemic disease.  Graft-versus-host disease, a potentially fatal complication from bone marrow transplant, involves the newly implanted cells attacking the patient’s body.  Until now, there have been no approved treatments for the disease.  Prochymal is designed to control inflammation and promote tissue regeneration.  Since the drug is made up of bone marrow stem cells derived from an adult donor, it circumvents ethical concerns that are raised by the use of stem cells derived from embryos.  The Canadian approval is contingent on Osiris conducting further post-market testing—and it’s anticipated that if the FDA approves the drug … Read More »

In a significant opinion for the pharmaceutical industry, the U.S. Court of Appeals for the Seventh Circuit found this week that pharmaceutical sales representatives at Eli Lilly and Abbott Laboratories are exempt from overtime under the administrative employee exemption in the Fair Labor Standards Act (“FLSA”).  That exemption applies to employees who 1) primarily perform nonmanual work directly related to the business of the employer, and 2) exercise discretion and independent judgment with respect to matters of significance to the business of the employer.

The Seventh Circuit, rejecting the position of the Department of Labor as amicus curiae, found that the administrative exemption applied because the substantial work of the sales representatives is to prepare for, make, and document their sales calls to physicians to persuade them to prescribe the companies’ products, and that they exercise “significant discretion in the manner and mode of delivery of … Read More »

The government has made available materials relating to Abbott’s $1.5 billion settlement.  (See link below).  Here are some quick observations.

Abbott pled guilty to a misdemeanor for “misbranding” its drug Depakote as a result of off-label promotion.  Between January 1998 and December 2006, Abbott promoted Depakote to treat behaviors associated with dementia, but FDA had approved the drug only to treat certain types of epileptic seizures and biopolar mania, and to prevent the onset of migraines.  (That’s all according to the Plea Agreement and Agreed Statement of Facts filed in court).  Abbott has agreed to pay a criminal penalty of $500 million and an additional forfeiture of $198.5 million.

The documents filed in court as part of the plea indicate that the value of the misbranded drugs was $198.5 million (that’s why the forfeiture was for that amount) and … Read More »