Among the many stats that illustrate the biopharma industry’s rough and tumble 2016, new drug approvals fell to their lowest total in nearly a decade after a booming few years.

What happened? If you ask the Food and Drug Administration, drug makers got a little worse at their jobs, and the agency got better at its own. But some analysts say it’s likely just a calendar-related blip that should give way to a more profligate 2017 and beyond.

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  • Let’s not forget that the FDA also approves medical devices, and there are significant patient safety problems that were not addressed by 21st Century Cures. It is time to prescreen patients for immune reactivity to determine if device materials are “right for you” before permanently installing them in the body or the mouth. The costs and consequences of this preventable harm are a significant, often overlooked, hard-to-diagnose and hard-to-treat, and costly chronic disease burden on individuals, families, employers, health plans and government. https://www.statnews.com/2016/12/21/medical-devices-safety-congress/

  • In pharma it is axiomatic that a great company can take a halfway decent drug and figure out a way to get it approved, whereas an incompetent company can take a great drug and fail to get it approved, seems in this case many because of cGMP issues.

    Must be remembered that biotech is a long term play. For example if you bought into the Blackrock Biotech iShares ETF in 2006 ten years later your returns would have increased about 250% versus about 58% for the overall S&P 500 Index.

    Trump is all about results. He has not contacted Cailiff because he’s probably getting ready to can him based on 2016’s miserable results. Look for Dr. Scott Gottlieb, fellow of the American Enterprise Institute and formerly with FDA to be made the next Commissioner, or maybe just anoint him as Drug Regulatory Czar in deference to Trump’s Kremlin buds.

    • Cailiff should not only be fired him and his cronies should be investigated for insider trading and conspiring with hedge funds shorting activities. Definately a currupt agency needing a through scrubbing.