Today, the Commonwealth Fund published an On the Point blog post detailing the impact the unfortunately named Hatch-Waxman Integrity Act of 2018 would have if it were to pass Congress. The amendment would ultimately delay generic drug competition and increase drug prices. Senator Orrin Hatch indicated he would make the Hatch-Waxman Integrity Act his “top priority” during his remaining time in office.
The Hatch-Waxman Integrity Act of 2018 comes on the heels of the CREATES (Creating and Restoring Equal Access to Equivalent Samples) Act overcoming a significant hurdle by passing the Senate Judiciary Committee with a bipartisan vote. Introduced and withdrawn during the Judiciary Committee meeting by Sen. Hatch as an amendment to the CREATES Act, the Hatch Amendment would prohibit generic drug manufacturers from challenging the validity of brand-name manufacturers’ patents through an administrative remedy known as inter partes review (IPR). Despite its name, the Hatch Amendment does not improve the Hatch-Waxman Act.
The IPR process is critical to allowing generic drug manufacturers to challenge “low-quality” or invalid patents from brand-name manufacturers and is a low-cost, effective way to evaluate patents that may have been wrongly issued. Efforts to weaken the IPR process could have the effect of hindering efforts to lower drug prices by slowing generic drug market entry and price competition. If the goal is to reduce drug prices, there are other policy solutions that exist that can restore the balance between innovation and price competition.
Read more here.