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What Will Happen When FDA Gets Too Cozy with the Pharma Industry?

What Will Happen When FDA Gets Too Cozy with the Pharma Industry? | Pharma Industry Regulation |

Evidence is piling up to support the idea that the Food and Drug Administration — under President Trump and new Commissioner Scott Gottlieb — is lowering the regulatory bar for drug approvals. It would be foolish to draw definitive conclusions at this point, but it sure looks to me as though the agency’s relationship with the drug industry is cozy these days.


What does that mean for investors — and patients ? Let’s walk through it.


First, the evidence: On Tuesday, the FDA said “never mind” to its own demand that Amicus Therapeutics conduct a phase 3 study for a rare disease drug. The FDA had wanted another trial to look more closely at side effects. Now, in a rare reversal, the FDA is allowing the company to seek approval based on existing clinical data.


In late June, the FDA approved a new blood thinner from Portola Pharmaceuticals based on a single clinical trial that failed to meet its primary endpoint. Last week, a new drug for sickle cell secured FDA approval — and market exclusivity as an orphan drug — even though its active ingredient is widely available as an over-the-counter nutritional supplement.


It doesn’t really matter if the FDA approves more drugs if doctors don’t prescribe them and insurers don’t cover them. The companies can’t make money if their medicines sit in a warehouse. And some astute analysts predict that is exactly what will happen if the FDA lowers the bar. Faced with a flood of new drugs of questionable efficacy, insurers will simply refuse to pay, or will put in place bureaucratic hurdles that deter doctors from writing prescriptions.


Further Reading:

  • “Dr. Scott Gottlieb’s Plan to ‘Get Things Done’ at #FDA is Approved by #Pharma”;
  • “Does Pharma Really Want to Abandon the ‘Gold Standard’ of the FDA Approval Process?”;
  • “Pharma Scientists Concerned About Gottlieb’s Industry Ties”;
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