jueves, 8 de agosto de 2019

Brief Updates on California and Colorado Drug Price Reporting Laws

Brief Updates on California and Colorado Drug Price Reporting Laws

Link to FDA Law Blog

Posted: 07 Aug 2019 08:54 PM PDT
California

Last week, U.S. District Court Judge Morrison C. England Jr. denied the state of California’s motion to dismiss PhRMA’s lawsuit challenging SB 17, which was signed into law in October 2017 and became effective on January 1, 2018.  (Our summary of SB 17 is available here.)  As we previously reported (see herehere, and here), PhRmA challenged the implementation and enforcement of SB 17 on the grounds that the law’s notice, reporting and justification obligations are unconstitutional.  More specifically, PhRMA has argued that SB 17 violates the First Amendment, the Commerce Clause, and the Fourteenth Amendment’s Due Process Clause.  The state sought to dismiss the lawsuit, but Judge England found that PhRMA’s “non-conclusory” allegations could proceed.

Colorado

As we previously reported (here), Colorado recently enacted HB 19-1131, which requires drug manufacturers to provide prescribers with a drug’s wholesale acquisition cost (WAC) during marketing activities.  Drug manufacturers must also provide prescribers with the names of at least three generic prescription drugs from the same therapeutic class.  Although the state has not yet issued regulations or guidance regarding these “Prescription Drug Cost Education” requirements, the new law took effect on Friday, August 2, as no referendum petition was filed with the Colorado Secretary of State.

We will continue to monitor and report on state price reporting and transparency efforts.

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