A district court judge in New Jersey heard oral arguments this week with respect to claims brought forth by four pharmaceutical companies that the Inflation Reduction Act’s drug price negotiation provision violates certain constitutional rights. According toLegal challenges to the Medicare drug price negotiation provision contained in the IRA have thus far faced skeptical judges.
It’s unclear if the court will view the maximum fair price as government-dictated. The IRA introduces a mix of both price controls and negotiations . The coercion argument may prove difficult to win over judges. The IRA defines qualifying single source drugs as medications that are approved under the New Drug Application or Biologics License Application regulations governing the Food and Drug Administration. Furthermore, they may not be selected if they have generic or biosimilars “approved and marketed” pursuant to an abbreviated NDA or BLA.
But this does raise questions around what constitutes bona fide marketing and therefore which branded products can be selected and which cannot. To illustrate this ambiguity, note that Humira wasn’t chosen by CMS for price negotiations despite it being a top-selling product more than 20 years past its first approval date.
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