Drug shortages, drug costs, the questionable quality of over-the-counter medicines: myriad issues have developed in pharmaceuticals in an era of enhanced regulatory efforts, rising healthcare costs and a global economy in which drug components are manufactured around the world. The new war on drugs is a policymaking battle in the legislative arena not over illicit back-alley dealing, but over cost, control and accessibility of the pills populating Americans' medicine cabinets.
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There is a growing concern that American patients are unknowingly being given unsafe medicines from overseas. Yet with nearly 3 billion prescriptions filled every year in the United States, everyone agrees that the U.S. drug supply is generally safe.
A new regulation proposed by the Food and Drug Administration will compel generic drug makers to update their labels to reflect “new” safety issues. This new rule is a poor tool for keeping generic drug labels up-to-date, and it will come at a significant cost to consumers. If public health is the true imperative for this change, the FDA can address the generic labeling issues in far better ways.
As busy as the digital health space has been lately, one group of stakeholders has been conspicuously absent from the proceedings: pharma companies. Shame on anyone who is surprised.
The FDA has issued a new regulation that could open generic drug makers to the same sort of product liability suits that plague branded pharmaceutical companies.