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Mark Cuban Tests If A Compounding Pharmacy Can be a Generic Manufacturer
(Thursday, February 3, 2022) Compounding essential drugs at low cost is not a new idea but branding them as generic drugs is risky. Celebrity billionaire Mark Cuban announced a new generic drugs company that pledges to manufacture and sell prescription generic drugs at lower costs however the company will initially start a compounding pharmacy and then later convert to a generic manufacturer. The compounding pharmacies do not go through the same GMP requirements and FDA approval requirements like generic manufacturers. A compounding pharmacy only registers as an “outsourcing facility” and can start shipping almost immediately upon start of business. On the other hand, a generic manufacturer must first manufacture GMP-compliant batches of a given drug, then depending on the product, do human bioequivalence studies, file a formal ANDA application (which is a fee-bearing application), wait for FDA to review and approval of the generic drug (a process that can take up to a year post submission) before being able to sell the drug. The process from product concept to market could take anywhere from 2-4 years for each drug product. Most compounding pharmacies, who made similar claims as Mr. Cuban to reduce the cost of the drugs, could not make the switch due to the complexity of the process and the cost. But they did not have the backing of a billionaire, so may be this time it is different. But if reducing cost is the main reason for this venture, then one must consider manufacturing at a less expensive location. The cost of running a facility in Houston is several folds higher than doing the same in India, China, and many other parts of the world. That’s the reason generic manufacturers from those parts of the world rule the space. The reasons drug cost more is not directly linked to the cost of manufacture but due to the cost of distribution and marketing. Add to that the cost of monopolies and greed of the investors, and you have an expensive generic in your hands. If you control distribution, you can sell drugs at a much lower cost. Even Mr. Cuban’s company will initially start by relabeling the drugs manufactured at other locations. So, why not use that model to get cheap drugs to Americans now and in future? May be that’s a question for the Shark Tank. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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