issues at Princeton University, where there has been an outbreak of a form of bacterial meningitis that is rare in this country and trustees were weighing whether to offer a vaccine that has been approved in Australia and Europe but not here in the United States. 2. In the New England Journal of Medicine, Janet Woodcock and colleagues from the FDA’s Center for Drug Evaluation and Research discuss the new “breakthrough therapy” designation and provide a helpful chart comparing it to the FDA’s other accelerated approval programs. Woodcock and colleagues conclude that “[a]s the pace of scientific discovery continues to increase, drug development pathways will need to evolve in parallel.” 3. At the FDA Law Blog, Dara Katcher Levy comments on a November 8, 2013 Warning Letter, in which the FDA’s Office of Prescription Drug Promotion “alleges that statements made by Aegerion Pharmacueticals’ CEO during broadcast interviews on a CNBC talk show, ‘Fast Money,’ constitute evidence of a new, unapproved, intended use for its drug, Juxtapid (lomitapide) capsules.” Ms. Levy explains that “[t]his is the first OPDP Warning Letter that takes issue with an initial broadcast of statements aimed at the financial community, rather than the re-distribution of these materials for purposes of product promotion or as part of a ‘media pitch’” and writes that she is “interested to see whether OPDP will be increasing its enforcement focus on investor-related materials and other materials intended for the financial community.” 3. At JAMA, Bridget Kuehn addresses the American Psychiatric Association’s contribution to the Choosing Wisely initiative, five recommendations for when physicians should avoid–and patients should question–prescribing an anti-psychotic medication. Kuehn quotes Robert Rosenheck: “The unanswered question is how to discourage inappropriate use of the drugs without impinging on physicians’ rights to prescribe them off label when they feel their use is warranted[.]“ 5. Finally, Ed Silverman at Pharmalot reports on the European Medicines Agency’s decision to delay finalizing its new policy on disclosing patient-level clinical trial data. Silverman writes: “There was no indication that the draft policy will be changed, but the potential delay does suggest the possibility that the agency may consider modifying its language. If nothing else, the move underscores the volatility surrounding its plan and vehemence with which the larger issue of disclosing clinical trial data is regarded.”1. Of great interest this past week were the continuing In August of this year, a federal district court upheld a California ordinance requiring drug manufacturers who sell drugs in Alameda County to implement and fund a drug disposal program. This ordinance, which shifts the costs of drug disposal from local governments back to the originators of the drugs, is the first of its kind but if sustained it won’t be the last. In December 2012, PhRMA, the trade organization for drug manufacturers, challenged the ordinance on constitutional grounds, stating that it impermissibly interfered with interstate commerce. The District Court disagreed. Facing the possibility of incurring massive costs if such ordinances were implemented nationwide, PhRMA now appeal s. Alameda County’s ordinance provides that manufacturers of drugs which are sold or distributed in Alameda County are responsible for operating “Product Stewardship Programs.” These programs must pay for the costs of “collecting, transporting and disposing of Unwanted Products collected from Residential Generators and the recycling or disposal, or both, of packaging collected with the Unwanted Product.” Additionally, the manufacturers are expected to pay administrative fees associated with enforcing the ordinance, which are estimated at $200,000 annually. The ordinance prohibits manufacturers from shifting any of these costs to the consumers. PhRMA argued that the ordinance was a per se violation of the Commerce Clause because it discriminated against interstate commerce by shifting local costs to interstate manufacturers, who would presumably shift these costs to consumers nationwide. The District Court rejected the assertion that this was the type of discrimination which implicates the Commerce Clause. Because PhRMA failed to demonstrate, or even argue, that the ordinance favors in-state drug manufacturers over out-of-state manufacturers, the Court stated there was no per se violation of the Commerce Clause. The Court went on to hold that the ordinance did not attempt to directly regulate interstate commerce because the ordinance applies only to activities which occur within Alameda County, i.e. the sale, distribution and disposal of drugs within that jurisdiction. Next, the Court held that the balancing test used for activities which have an indirect effect on interstate commerce was likewise unmet. Alameda County had shown a legitimate interest in regulating drug disposal for health and environmental reasons and PhRMA failed to show that its burden in funding the program outweighed those interests.
This is a case to watch. If this ordinance is upheld, similar ordinances will likely be enacted throughout the rest of California and potentially around the United States.