An organization of Michigan biotech companies is looking for a permanent fix for a law they say unfairly burdens medical device companies.
The Pharmacy Control and Drug Practice law went into effect in September. It was originally intended to improve the safety of drug products sold by compounding pharmacies.
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, according to MichBio.
One of the requirements of the law is that companies must hire a pharmacist to oversee safety of the product supply chain. Shortly after the law passed, medical device companies began receiving notices that they were not in compliance, MichBio President Stephen T. Rapundalo says.
State Sen. Joe Hune, R-Hamburg Twp., introduced the legislation following an outbreak of meningitis that was linked to tainted steroids from the New England Compounding Center of Massachusetts. Michigan was one of the hardest hit states, with 22 deaths and 260 infections.
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 seems ridiculous and certainly overreaching," says Rapundalo.
MichBio has worked with LARA to clarify its concerns 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," says Rapundalo.
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.
