Tag: Food & Drug Administration

Runaway Preemption: The Reckless Doctrine of Pliva and Mutual Pharmaceutical – Note by Michael E. Bowlus

From Volume 88, Number 4 (May 2015)
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In March 2014, Gordon Johnston issued an urgent warning to members of Congress: the Food and Drug Administration was “[d]isregarding decades of regulatory stability” by proposing a new regulation that “raises patient safety concerns and threatens the system that created thousands of affordable options for consumers.” Johnston, himself a former deputy director at the FDA, was joined at a press briefing by economist Alex Brill, who estimated that the proposed regulation, if approved, would raise annual U.S. health care costs by $4 billion. 

Just what, exactly, was the FDA proposing to do? In the Agency’s words, it sought to “clarify procedures” allowing drug manufacturers “to change . . . product labeling to reflect certain types of newly acquired information.” In plain English, the ultimate consequence of the rule would be explicitly to permit generic drug manufacturers to update their labels with new safety warnings on a temporary basis, pending subsequent agency approval. Under current regulations, brand-name drug manufacturers are already able to update their warning labels in a similar fashion. However, the Agency has taken different positions over the years regarding whether generic drug manufacturers may update their labels. The proposed rule, announced in November 2013, would eliminate the ambiguity by establishing parity between both types of drug manufacturers with respect to label updates.

 

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The Rise of U.S. Food Sustainability Litigation – Article by Stephanie Tai

From Volume 85, Number 4 (May 2012)
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This Article provides one of the first critical looks at the interface between the values of the sustainable food movement and its rising use of litigation. In particular, it focuses on two growing areas of food sustainability litigation–challenges to Concentrated Animal Feeding Operations (“CAFOs”) and challenges to the use of genetically modified organisms (“GMOs”) in the food system–chosen because they involve growing sectors of U.S. agriculture over which members of the sustainable food movement have raised significant concerns.

 

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Psychotropic Medication and Foster Care Children: A Prescription for State Oversight – Note by Michelle L. Mello

From Volume 85, Number 2 (January 2012)
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On April 16, 2009, seven-year-old Gabriel Myers locked himself in the bathroom of his Florida foster home and took his own life. Just three weeks prior, Myers was prescribed Symbyax, a combination of antidepressant and antipsychotic drugs not approved by the U.S. Food and Drug Administration (“FDA”) for use in children. Myers’s Department of Children & Families (“DCF”) records document a tragic history of neglect, allegations of sexual abuse, and movement between at least four foster care placements after removal from his mother’s care. Diagnosed with attention deficit hyperactivity disorder, mood disorder, and possibly depression, Myers took several medications including Lexapro and Vyvanse. After his death, DCF appointed a Work Group to assess Myers’s case as well as the use of psychotropic medication for other children in state foster care. While the Work Group determined that safeguards in Florida existed, the “core failures in the system . . . stem[med] from lack of compliance with [such safeguards] and . . . failures in communication, advocacy, supervision, monitoring, and oversight.”

Giovan Bazan was only six-years-old when he was first treated with medication for hyperactivity. Years later, while taking Ritalin at a double dosage, he was prescribed an antidepressant after another physician saw him “so mellowed out that he barely reacted.” Twenty-year-old Bazan is now free of all medications and recognizes that “[t]hey start you on one thing for a problem, then the side effects mean you need a new medicine . . . [a]s a foster kid, I’d go between all these doctors, caseworkers, therapists, and [it] seemed like every time there was a new drug to try me on.”

 

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Using Numerical Statutory Interpretation to Improve Conflict of Interest Waiver Procedures at the FDA – Note by Saurabh Anand

From Volume 83, Number 4 (May 2010)
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Conflicts of interest frequently arise when industry experts advise federal agencies. Critics claim agencies’ decisions to waive conflicts of interest often lack consistency and clarity, but they have yet to propose a comprehensive system to improve the conflict of interest waiver process.

 

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