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New drug law burdens medical device companies


An organization of Michigan biotech companies is pushing to fix for a law they say unfairly burdens medical device companies with a requirement to hire a pharmacist.

The Pharmacy Control and Drug Practice law, Public Act 280 went into effect Sept. 30, 2014. It was originally intended to improve the safety of drug products sold by compounding pharmacies in Michigan, but Michigan's Department of Licensing and Regulatory Affairs (LARA) and the Attorney General's office pushed to expand the legislation to cover all manufacturers, distributors, and wholesalers of drugs and durable medical equipment.

One of the requirements of the law is that companies must hire a pharmacist to oversee the safety of the product supply chain. Shortly after the law passed, medical device companies began receiving notices that they were not in compliance, according to Stephen T. Rapundalo, President of MichBio

Michigan Senator Joe Hune introduced the legislation following an outbreak of meningitis that was linked to tainted steroids from New England Compounding Center, of Massachusetts. The multi-state outbreak caused deaths and infections, and Michigan was one of the hardest-hit states. 

But most medical devices don't involve pharmaceuticals and pharmacists lack the qualifications to supervise the device supply chain. "In most cases medical devices don’t even touch pharmacies. They are products that go directly to health systems and physicians. To put that kind of burden on a medical device company just obviously seems kind of ridiculous and certainly overreaching," says Rapundalo.

MichBio has worked with LARA to clarify the issues and existing oversight by the FDA. 

"From there we tried to work with some of the legislators including the original sponsor to, at the very least, get some kind of temporary patch or fix until such time as all the stakeholders could sit down and work out a more permanent solution."

Public Act 449 offers temporary relief, allowing companies to designate a facility manager instead of a pharmacist. However, it does not go into effect until March 1, 2015, and in the meantime it's unclear whether LARA will enforce the original regulation.

MichBio is hoping for a permanent legislative solution in early 2015.