The Patent Use Code Conundrum – or Why FDA Can’t Read (Patents)


When Hatch-Waxman was adopted 30 years ago, Congress wanted to ensure that generic manufacturers could enter the market with low cost drugs just as soon as the initial protections on the brand drug had expired.  Specifically, Congress was concerned about “evergreening,” whereby new, protected indications might be added to the brand label to thwart generic entry and extend the life of the drug monopoly.  Congress said there was no reason why a generic drug could not be approved for older, unprotected uses at the same time the brand was being sold for newer uses protected by patent or exclusivity.
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The Efficiency of Bringing Drugs to Market Versus the Fairness of Making Drugs Accessible


As the 2014 Ebola outbreak continues to spread in West Africa, drug companies, national governments, and public health entities as a whole are coming under increasing criticism for failing to offer what many would view as equitable approaches to addressing public health epidemics, particularly those occurring in poor or developing nations. Indeed, public health threats like the Ebola virus challenge drug companies to find the right balance between making unproven treatments available to desperate populations and ensuring the safety and efficacy of treatments that have yet to undergo comprehensive clinical testing. Furthermore, striking such a balance highlights a medical ethics issue that has haunted some of these drug companies in the past: conducting clinical trials on foreign populations with few of the ethical and safety protections required by western cultures, yet then pricing drugs out of the market for these same populations once they are FDA approved.
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Is Your Pharmacy Compliant with the FDA’s New Rules on Interstate Shipment of Compounded Drugs?


Interstate distribution of compounded drugs became a focus of the U.S. Food and Drug Administration (FDA) following a recent, highly publicized incident involving the shipment of contaminated medications across state lines. Drug compounding, in general, is preparing a medication that is not commercially available in the strength, concentration, or form needed for a specific patient pursuant to a prescription.  Traditional, non-sterile, drug compounding generally includes medication patients drink, swallow, insert, or apply to skin.  In contrast, non-traditional, sterile, drug compounding typically includes medication intended for injection, infusion, or application to the eyes.
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