TheFDADoesn’tNeedaWreckingBall.ItNeedsaRebuild.

What a nasty Friday for biotech.Generally a weak market day but biotech took a major thumping.After initial enthusiasm for Makary firing perhaps some recalibration.Of course the market was anticipating Makary departure as evidenced by relentless move higher by $REPL in the last 10 days.The loss of multiple career FDA reviewers and the flagging morale at the FDA certainly is causing investor jitters to say nothing about macro headwinds.

I tend to look at the current situation as a glass half full situation.The administration recognizes that things have to change.The FDA had been living on its past glories for decades and it’s obstructionist ways have to change. One thing worse than the loss of career scientists and reviewers at the FDA would be further losses of creative scientists and innovative doctors in the bleeding edge of biotechnology.We can’t cede another of our great industries to China.Big Pharma continues to pour money into Chinese biotech because their government supports and encourages their companies with a simpler more predictable regulatory environment.

We need a rebuild at the FDA emphasizing predictability and encouragement of bold innovation.Would Keytruda have been fast tracked by the current FDA and if so why has $IBRX and other platform drugs not received more encouragement.Makary and his one man wrecking ball Dr Vinay Prasad certainly were not the answer.I think they’ll get it right and send the proper signals to the biotech industry.Enough talking about right to try let’s make it happen.