The State of Michigan Licensing & Regulatory Agency (LARA) and the Attorney General Office (AGO) have further clarified rules that would address oversight of drug and device manufacturers/wholesalers and their product supply chains. The latest amendments to definitions, requirements, and processes that govern licensing were unveiled at a stakeholders meeting held this week in Lansing.
The Pharmacy Practice & Drug Control Act of 2014 (PA 280) was passed to address the lack of sufficient state authority to hold compounding pharmacies accountable for adverse effects of tainted drug products (i.e., in response to the 2012 Meningitis outbreak that led to many deaths in Michigan and other states). Both LARA and the AGO broadened the scope of the law’s language to encompass all medical products that are ultimately utilized by patients. As a result it placed undue compliance requirements on manufacturers/wholesalers, like necessitating a “Pharmacist in Charge (PIC)” to be hired and serve as the accountable party for drug and device firms handling such products.
Amendments were made to PA 280 in late December 2014 to address some unintended consequences. Device companies indicated that a PIC requirement was burdensome to them and of no practical utility, as most pharmacists have no expertise with durable medical products or prescription devices. In related fashion, pharmaceutical companies typically already have a facility or designated manager responsible for product viability at their facilities, and thus a PIC was not necessarily needed, though some drug manufacturers do utilize such personnel. The latter was also valid to wholesalers/distributors.
Recent discussions between LARA, AGO, and biopharma stakeholders have focused on resolving the outstanding issues. They include the following:
Medical devices will remain exempted per the amendments passed in late 2014: “A person that is a manufacturer or wholesale distributor with respect to a device salable on prescription only but not with respect to any drug salable on prescription only is exempt from this subsection.” Note: durable medical goods are already exempted per definitions in the Michigan Health Code.
New legislation would allow for the option of either a PIC or facility manager as the designated responsible party. This would apply to wholesale distributors and non-compounding pharmaceutical manufacturers. Requirements for a facility manager have now been defined and will include fingerprinting and background checks.
There will be a new requirement for notification of any adverse events not related to an allergic reaction. Specific language is still being worked out, but will be consistent with FDA requirements.
Clarification is being introduced in describing PIC responsibilities not only for a pharmacy, but also manufacturers and wholesalers.
Significant progress has been made and it’s likely that legislative amendments will be made later this spring or early fall.