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The FDA just broke a recent record for most new drug approvals in a year, hitting a not-entirely meaningful (but not altogether meaningless) milestone for an agency that has long promised to pick up the pace.

With today’s green light of La Jolla Pharmaceutical Company’s Giapreza, a treatment for dangerously low blood pressure, the FDA hit 46 approvals for the year. That’s the most in at least a decade.

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  • This is labeled a biotech column. Yet STAT almost always focuses more on drugs, pharma and FDA approvals. Where is STATŝ emphasis on coverage & critical appraisal of existing and new medical and dental devices? Spotlight on FDA’s outdated 41 year old device approval & monitoring framework which UDIs are not sufficient to fix? Coverage of significant and sustained patient harm and patient and physician organizing to get FDA to act to prevent harm to others? Gaps without any meaningful data collection for adverse dental events as FDA adverse event forms do not even MENTION dental?

    What about a focus on the need for a Precision Device framework – where it is truly needed – as devices deliver 24/7/365 exposures, are difficult and costly to remove, and are often overlooked as a cause of serious chronic health problems when the body reacts poorly to them? Patients are not all average, and too many are outliers with respect to genetic and exposure differences and their impact on allergies, immune reactivity, and tolerance vs. toxicity from bioaccumulation of 24/7/365 exposures. That we don’t do patch testing and MELISA-type testing before installing medical and dental devices is ironic as well as tragic, as FDA recommends patch testing before using hair dye.

    Good grief, you would never know from two years of STAT reporting that there are systemic – not occasional – problems in FDA device regulations and device safety. How about a scorecard and tracking of FDA’s pace in holding companies’ feet to the fire in post-approval monitoring studies, issuing black box warnings, bans and recalls, encouraging patients and physicians to do timely adverse event reporting across the board from medical to dental, and adopting a Precision Device and Precision Dental framework? Other nations have figured out how to more quickly stop problematic devices and common allergenic and neurotoxic materials from still being used after proven harmful. We are enmeshed in a conflict-of-interest fueled denial of international research evidence that is widely accepted outside of the US, with a blindness fed by media silence.

    Kindly resolve to address these issues and challenges in the New Year. Thank you.

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