Medical Device Companies Under Threat in Michigan
Friday, January 30, 2015
A new Pharmacy Control and Drug Practice law, Public Act 280, in Michigan that took effect as of September 30, 2014 threatens any medical device company licensed to sell products in Michigan.
The legislation was passed following a comprehensive review of existing state regulations and statutes in the wake of the 2012 meningitis outbreak linked to New England Compounding Center (NECC), a now-defunct Massachusetts company, which allegedly distributed tainted steroid injections to patients at clinics around the country. Michigan patients were hit hardest by the multi-state outbreak, with 264 infections and 19 deaths.
The new law requires that all manufacturers/distributors/wholesalers of pharmaceuticals and durable medical equipment must apply for a license to sell their products in Michigan. To qualify companies must have a “pharmacist-in-charge” (PIC) who is licensed and responsible for ensuring all state laws and regulations are followed to secure the entire supply chain from manufacture to patient.
Definitions of “wholesaler” and “prescription only” contained within the Act could pertain to nearly all medical devices and their method of distribution. Under the Act, medical devices companies might be considered “non-compounding distributors.” For companies that are VAWD (Verified-Accredited Wholesale Distributors) accredited, these requirements may be significant overkill and could require pharmacists being asked to take ownership of the operations of device warehousing activities, which they are not qualified to do.
The problem for medical technology companies? Simple… pharmacists have nothing to do with medical devices and it is overreaching to require a medical device company hire or subcontract one. Nevertheless, the Licensing and Regulatory Agency (LARA) and the Attorney General’s Office (AGO) are intent in having the authority to go after anyone who could adulterate a product that ends up being used by a patient. Letters of non-compliance or noticing of the new law’s requirements were sent out to various device companies by the agency and that was what first brought the issue to our attention.
MichBio has led the charge, in concert with representatives from various medtech companies (J&J, BD, Boston Scientific, Stryker, Bayer, Baxter, Cardinal Health, and many others), to find permanent relief of the law’s requirements insofar as they impact device manufacturers/wholesalers/distributors. But small Michigan companies are impacted too—several manufacturers were cited for being out of compliance with the new law and requested to hire a PIC.
Following several meetings with LARA, AGO, and key state legislators (including the original sponsor, Sen. Joe Hune (R-Howell), a temporary legislative fix was passed as Public Act 449 wherein medical device manufacturers/wholesalers/distributors are exempt from the Pharmacy Control law. Furthermore, the PIC requirement was loosened to permit a designated Facility Manager instead. PA 449 takes effect as of March 1, 2015 so some question still remains as to whether LARA will enforce PA 280 in the mean time.
A permanent legislative solution is planned for early 2015. All the stakeholders plan to meet and come to an agreement that satisfies respective interests. The hope is that medical device companies will continue to be exempt from PA 280’s requirements.
Any company that has been contacted by LARA regarding non-compliance with the Pharmacy Control law and delayed in its licensure application should contact MichBio at email@example.com immediately. It is important that we share with LARA and legislators the needless impact the law is having on our companies.