The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...20 January 2017
Ninth Circuit Upholds Alameda County's Safe Drug Disposal Ordinance
A consortium of non-profit trade organizations representing the manufacturers and distributors of pharmaceutical products challenged the Alameda County ordinance under the Commerce Clause, under which states and localities may not unduly interfere with interstate commerce. The Ninth Circuit rejected the plaintiffs’ argument under the Supreme Court precedents that apply a two-pronged approach to determine whether a state or local law violates the Commerce Clause. Under the first prong, the Ninth Circuit had to determine whether the ordinance “either discriminates against or directly regulates interstate commerce.” The court held that it does neither. In the court’s view, the ordinance is not discriminatory because it treats all drug manufactures exactly the same regardless of where they are located, and it does not directly regulate interstate commerce because, as two stipulations between the parties revealed, the ordinance does not control conduct beyond the borders of Alameda County. The court then moved onto the second prong, which required the court to assess whether the burden the ordinance imposes on interstate commerce is excessive when compared to the benefits it conveys on Alameda County. The court, finding that the plaintiffs “provide[d] no evidence” that the ordinance will affect the interstate flow of goods, determined that it does not. The court’s decision remains subject to appeal.
Alameda County began implementing the ordinance in July 2014 but is still working with companies to develop their required stewardship plans. Although no product collection has been undertaken pursuant to the ordinance, absent a successful appeal, the Ninth Circuit’s recent decision clears the way for product collection to commence, likely sometime in 2015. Implementation of a similar ordinance in King County, Washington, is expected to proceed as well. Additional State and local governments across the country will undoubtedly consider adopting pharmaceutical take back programs as well and producer take-back programs for other products may not be far behind. Producers will need to look closely at these programs to see if they are covered, and if so, will need to assess the most cost-effective means of achieving compliance.
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published guidance for companies submitting a Manufacturing Authorisation application or variation on...06 January 2017
On 16 December 2016, the European Medicines Agency (“EMA”), along with the European Biopharmaceutical Enterprises (“EBE”) organised the fifth annual regulatory...03 January 2017