Statutes and regulations should have a purpose. There should be an articulable reason why a company is legally compelled to take or refrain from a specific action. Regulation without purpose or reason is antithetical to American entrepreneurship. Some industries are over regulated because it is politically popular to regulate them. America's pharmaceutical industry is presently very near the top of this list. Not only is our pharmaceutical industry regulated by the federal government, but also by every individual state. The regulations apply to both large and small manufacturers, brand and generic, as well as wholesalers and distributors.
Many of the regulatory requirements imposed on our pharmaceutical industry appear to be regulation for the sole purpose of regulating. On July 9, 2014 Michigan signed into law a requirement that all pharmaceutical manufacturers and wholesalers, whether or not located in Michigan, must have a registered pharmacist on staff in order to obtain a license to distribute products into the state. Let's think about this. A pharmaceutical company that has researched and developed a new product, gone through clinical trials, filed a NDA and received approval from the FDA to market and sell that drug can no longer sell to Michigan hospitals, pharmacies or distributors unless they hire a pharmacist to sit at their corporate office, which serves as the point of sale. This is not a requirement for direct to patient sales. It is required for sales to other licensed entities that will receive the product before it is eventually dispensed to a patient by a Michigan licensed pharmacist. The new requirement also applies to distributors and wholesalers. Its scope includes all companies that ship or sell into Michigan no matter where in the country they are located.
So what is the articulable purpose behind this new requirement? What evil is Michigan trying to prevent? The bigger question is, how does Michigan expect companies to comply with this requirement? Pharmacists are health care providers. All licensed pharmacists have either graduated from a five year Bachelor of Science program or a six year Doctor of Pharmacy program. Yes, they are Doctors of Pharmacy, qualified to render health care and participate in the drug management of individual patients. Does Michigan believe that there is a pool of unemployed pharmacists waiting to take jobs in a warehouse? How many pharmacists will give up their practice to work in a warehouse shipping pre-packed cartons of medicine? Perhaps we can expand this and get physicians involved in reviewing shipping manifests. Pharmacists are qualified to dispense drugs, identify drug-to-drug interactions, and recommend appropriate medication options while considering a patient's unique characteristics. What is not taught in pharmacy school is supply chain logistics. The Michigan statute is the epitome of regulation without thought. It is a shining example of burdening American businesses with oppressive obligations that serve no meaningful purpose.
What will happen to the hospitals and pharmacies in Michigan when companies either cannot or choose not to comply with such a requirement? Small branded and generic companies, and local distributors or wholesalers will not be able to find or afford to keep a pharmacist available to manage their records even for the minimum required eight hours per week. Michigan hospitals, doctors, and pharmacies may lose their ability to purchase direct. The increased cost of purchasing through wholesalers will be passed on to the people of Michigan. Michigan might want to take a step back and rethink this. There are other ways of achieving the desired end. Perhaps they will adopt a designated representative model like Florida and California. Or perhaps they will simply let the logistics people continue to do their job and take care of the supply chain.
Frank Fazio firstname.lastname@example.org @FrankFazioPLS