BRIEF—Hatch amendment to incentivize generic drug development

US Senator Orrin Hatch (Republican, Utah), the Chairman of the Senate Republican High-Tech Task Force and co-author of the Hatch-Waxman Act, at the Senate Judiciary Committee hearing, said that he has filed an amendment, the Hatch-Waxman Integrity Act of 2018, to restore the careful balance the Hatch-Waxman Act struck to incentivize generic drug development.

Senator Hatch’s legislation would prevent alternative procedures for challenging drug patents from tilting the playing field contrary to Hatch-Waxman’s design. It would also ensure that brand-name and generic manufacturers alike have the proper incentives to develop life-saving medications. The Senator decline Saved to offer the amendment in the markup for a vote.

“I have a keen interest in ensuring we have a well-functioning generic drug industry. Well, there are two sides to that coin. One is ensuring that generic companies are able to develop drugs. The other is ensuring that brand companies have sufficient protections in place to recoup their investments. It won’t do to give generics the ability to develop and market low-cost medications if brand companies don’t have the incentive to create those medications in the first place. And so Hatch-Waxman struck a careful balance, one that has endured for decades,” stated Sen Hatch.

For more information, click here. The text of the amendment is available  here. A detailed summary of the amendment is available  here.