May 17, 2018

The drug companies impeding access to generics

The FDA is calling out brand-name drug makers. Photo: Al Drago/CQ Roll Call via Getty Images

The Food and Drug Administration published a list Thursday showing pharmaceutical companies that the agency said could be using "gaming tactics" to delay generic competition with their brand-name drugs. Many drugs on the list, like Revlimid and H.P. Acthar Gel, have high price tags.

The bottom line: It's a big deal for the Trump administration to publicly shame drug companies for limiting access to their costly brand-name products. But the big question is whether this move, along with other policies, will make it easier for lower-cost generics to hit the market.

The details: The list displays the brand-name drugs (and their manufacturers) for which the FDA has received complaints from generic companies saying there is limited distribution and access to samples.

  • Drugs made by Celgene accounted for almost one-fifth of the FDA's complaints from generic drug makers, the most of any drug company. Revlimid, which had 13 inquiries, makes up 63% of Celgene's revenue.
  • Tracleer, a lung drug that is owned by Johnson & Johnson, had the most individual FDA generic inquiries with 14.

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