House Passes CREATES, 2 Other Bills Targeting High Drug Prices

The House of Representatives has passed HR 965, the Creating and Restoring Equal Access to Equivalent Samples Act of 2019 (CREATES Act), as well as 2 other bills dealing with drug prices: HR 1499, the Protecting Consumer Access to Generic Drugs Act of 2019, and HR 938, the Bringing Low-cost Options and Competition While Keeping Incentives for New Generics (BLOCKING) Act of 2019.

Whether or not the bills, which generally have bipartisan support, progress through the Senate and onto the president’s desk remains to be seen. The bills were packaged into the larger HR 987, the Strengthening Health Care and Lowering Prescription Drug Costs Act, which includes other bills targeting the Trump administration’s actions towards the Affordable Care Act.

The Washington Post reported recently that the move is aimed at undermining any Republican messaging on healthcare, as it restores funding for Affordable Care Act marketing and outreach as well as rescinds the expansion of short-term, limited duration health plans.

The CREATES Act has enjoyed broad bipartisan support since it was first introduced. It would allow a biosimilar or generic developer to bring a civil action against an innovator drug company if the latter refuses to make available enough samples of a product for testing. A parallel piece of legislation is also before the Senate.

CREATES was the target of heavy opposition from the Pharmaceutical Research and Manufacturers of America, which says that the proposed legislation would expose brand-name drug makers to significant risk and hinder innovation. But it has been praised by the Association of Accessible Medicines (AAM), which represents generic and biosimilar drug makers.

The BLOCKING Act discourages generic drug makers from delaying the start of their 180-day exclusivity period, allowing the FDA to approve a second generic application before the start of the first applicant’s commercial marketing.

The Protecting Consumer Access to Generic Drugs Act makes future pay-for-delay settlements between brand and generic drug manufacturers illegal. One report noted that in negotiations, Democrats agreed to a Republican request to strip out a portion of the bill that would have retroactively affected enforcement to 2013.

In a statement, AAM praised Congress for passing the CREATES Act, but said that, “Unfortunately, by packaging the CREATES Act with HR 1499, the Protecting Consumer Access to Generic Drugs Act of 2019, and HR 938, the BLOCKING Act of 2019, Congress has taken one step forward and two steps back. These bills, while well intentioned, will impede generic and biosimilar drug manufacturers from bringing new, safe, and more affordable medicines to market. HR 1499 and HR 938 will raise the price of medicine.”