For Cures Draft, Drug Exclusivity Still In Question

Roel Smart/
A new draft of the so-called “21st Century Cures” bill boasts a bipartisan deal struck over additional funding for the National Institutes of Health. But House legislators are still working out provisions regarding the exclusivity period for some new drugs.

At a House Energy and Commerce subcommittee hearing on Thursday, Reps. Frank Pallone (D-N.J.) and Jan Schakowsky (D-Ill.) expressed satisfaction at the removal of some of the exclusivity provisions in the first draft of 21st Century Cures that was released in January.

The Food and Drug Administration gives an exclusivity period to new drugs, during which generics are barred from entering the market. The period varies depending on the type of drug – “orphan” drugs, which cure rare diseases, can enjoy exclusivity for as long as seven years.

Pallone said he could support offering a limited amount of exclusivity for new drugs that fulfill an unmet need, but stressed that too much exclusivity could “undermine” the Hatch-Waxman Act, which formed regulations for generic drugs on the U.S. market.

“I do not want to undermine the balance between protection and competition that Hatch-Waxman has been so successful in achieving,” Pallone said.

While compromise-minded, Rep. Fred Upton (R-Mich.) remains intent on spurring drug makers with incentives. Upton, architect of 21st Century Cures, said he hopes to work out the exclusivity provisions with Democrats when the text begins the mark-up process.

“We will continue to work on a policy to provide incentives to develop drugs that, while they may have failed in trials for one indication, show promise to treat patients facing other serious or life-threatening diseases,” Upton said Thursday.

The first 21st Century Cures draft had a provision that would have extended exclusivity for some drugs up to 15 years from the current 12 year period.

Schakowsky expressed concern that providing more exclusivity for drugs could make drugs less affordable.

“If we are spending billions of dollars to incentivize the development of new drugs, we need to ensure that patients have affordable access to those therapies,” Schakowsky said.

The 21st Century Cures initiative kicked off last year with the goal of expediting the approval of new drugs and medical devices. Sources familiar with the legislation say Upton hopes to have it on the president’s desk by the end of the year.

Morning Consult