WASHINGTON — Food and Drug Administration Commissioner Scott Gottlieb on Wednesday accused drug makers who manufacture pricey biologic medicines of using “unacceptable” anti-competitive tactics to keep competitors off the market, costing Americans billions.
The tactics — some of which Gottlieb will refer to as a “toxin” — have prevented other drug makers from launching biosimilar medicines, highly similar versions of the same drugs.
“The branded drug industry didn’t build its success by being business naïve. They are smart competitors. But that doesn’t mean we need to embrace all of these business tactics, or agree that they’re appropriate,” Gottlieb said in a speech at the Brookings Institution. “Some of these tactics should be unacceptable to every member of the drug supply chain.”
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While this statistic seems compelling – “Americans could have saved $4.5 billion in 2017 if all of the FDA-approved biosimilars were actually available in the United States, ” – something is missing. That savings is computed against what figure and what percentage does that saving represent? If total spend is currently is $450 Billion (2016 figure – CNBC), then 40 pct of that is $180 Billion USD. I will never see $4.5 billion USD personally, so I will agree that’s a lot but it represents a discount of ‘only’ 2.5% – scarcely impressive. Driving that spending level down to $175.5 billion USD doesn’t seem like much – “just sayin’ “