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Docs 4 Patient Care member, Dr. Milton R. Wolf, has written an important op-ed for The Washington Times about the record number of drug shortages in the United States.
Wolf writes: "The FDA, despite its intentions, drives up the costs of medicines and often dries up the supply chain altogether. America is currently facing a shortage of about 246 drugs - a record high. This doesn’t happen by accident. Consider the alarming conclusions reached, not by the supposedly evil pharmaceutical companies, but by physicians and pharmacists at last year’s Drug Shortages Summit."
And, "A joint report by the American Society of Anesthesiologists, the American Society of Oncology, the American Society of Health-System Pharmacists and the Institute for Safe Medication Practices sounded the alarm: “Several drug shortages have been precipitated by actual or anticipated action by the FDA.” They note that the “cost and complexity” of the FDA’s “regulatory barriers” to providing new and even existing medicines is a “disincentive” to suppliers. Additionally, the “lengthy and unpredictable” approval process limits manufacturer’s ability to develop reliable production schedules." This has caused the drug approval process to increase from 7 months to 7 years!
One reason for this, as John Goodman explains, is that the FDA bureaucracy has a vested interest in inaction. The consequences and public scrutiny that comes to bear on the FDA for approving a drug (action) that eventually proves to be harmful, or has side effects, is high. Conversely, there is little public outrage caused when FDA inaction prevents a new drug from becoming available through bureaucratic delays (inaction), even if the denies a cure of treatment. Goodman writes that "both outcomes are bad for the public, but the consequences for the regulators are very different." Inaction has proven to be the safer course of action for the FDA.