How Good Are Your Drugs? (Part 4) - Page 3

American biotech companies are increasingly outsourcing drug research and purchasing outsourced raw ingredients, creating a framework that allows for the approval and production of Indian and Croatian biogeneric drugs. This may serve as a catalyst for American biotech companies to hasten the outsourcing of biologic production, and along with it, high paying biotech jobs.It has been evidenced that in the past, the pharmaceutical, distribution, dispense and insurance industries all appear to have allowed for the introduction of adulterated compounds into the mainstream manufacturing, distribution and dispense systems in violation of standards. The sale of adulterated pharmaceuticals to unwitting patients can be debilitating.Biologics involves increased scrutiny. Since these are live cultures, they are often infused so they have a direct route to vital organs and the central nervous system. Given the compromised condition of the patient population, any change or alteration of the manufacturing process can render the drug toxic, and the negative effects are immediate, and in many case life-threatening or even fatal. Biologics are much more sensitive to process changes than chemically manufactured drugs, although both scenarios can be dangerous. Most also have short shelf-life and require highly specialized (and expensive) handling in order to maintain product integrity and FDA approval. Lengthening the amount of time that biologics drugs spend in Indian or Croatian distribution and shipping channels doesn’t intuitively make a whole lot of sense.ConclusionIt is evident that state and federal governments have gaps in their control of the manufacture, distribution and dispense of pharmaceuticals in the United States. The FDA is failing to inspect the multitude of generic pharmaceutical manufacturing plants that are springing up throughout the world to meet the increasing demand, just as they appear to be failing to provide quality control for pharmaceuticals made in the United States.

Now, the United States wants to open the door to biogenerics. With little or no oversight of the process, the results could be disastrous for the patients who need these medicines to heal them.But the cost savings is so significant, some will say. Who cares if it may kill you? The prescription only costs you $4! If the label says zolpidem, the patient should be able to rest easy knowing that he or she has received zolpidem. Is that too much to ask?Written with help from Prevent Medical Error, a nonprofit organization that seeks to promote best practices. As a nonprofit, Prevent Medical Error has accepted contributions from donor holdings in UnitedHealth Group. Bristol Myers Squibb, Pfizer, and Forest Labs.Read Part 1, Part 2, and Part 3.

Article Author: Rick Vassar

Rick Vassar CPCU, ARM, AIS, ARM-P is a career commercial risk manager and the author of Hide! Here Comes the Insurance Guy, where he uses humor to explain insurance strategies in language everyone can understand.
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