Preserve Access to Affordable Generics and Biosimilars Act

The House Judiciary Committee has voted in favor of H.R. 2891, the Preserve Access to Affordable Generics and Biosimilars Act.  The Bill was also referred to the House Energy & Commerce Committee and so may have a few more hurdles before it moves to the House Floor.

The key aspect of the proposal is to create a presumption of anticompetitive behavior anytime a generic ANDA/biosimilar filer “receives anything of value” while also agreeing to forgo any “research, development, manufacturing, marketing, or sales of the ANDA product or biosimilar biological product.”  The proposal appears to limit use of this presumption only to situations where the FTC brings an action, and not a private antitrust claim.

A parallel bill  proposed by Sen. Klobuchar is pending in the Senate.

3 thoughts on “Preserve Access to Affordable Generics and Biosimilars Act

  1. 1

    As understood, “pay for delay” of generic drugs by patent holders in settlements with generics was already established as a dangerous practice raising an anti-trust issue by the Sup. Ct. [after a long FTC battle], but under “rule of reason” analysis. Presumably this legislation would change that to an automatic presumption of anticompetitive behavior? How much drug price impact would that have?

    1. 1.1

      This may seem a counterintuitive prediction, but to a first order approximation, I expect that this rule—if enacted—would have no discernible impact on prices. It is still a good rule to implement, but pay-for-delay, while egregious in appearance, is not a real cost driver. FDA reform is the real rich target if you really want to move the needle.

      1. 1.1.1

        Better yet, reform that invokes FULL transparency across ALL players in the Pharma spectrum — and let any and every one ‘follow the money.’

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