President Donald Trump has recently released his budget plan, and many within the healthcare sector are disappointed to see that The Creating and Restoring Equal Access to Equivalent Samples Act, or CREATES Act for short, has been left out. This bill promises to increase competition and lower prescription drug prices, by eliminating abusive delay tactics used to block the market entry of low-cost generic products. It had apparently been part of the budget negotiations right up until the final days, leading proponents of the bill to believe that it would easily secure a place in the budget plan.
The CREATES Act, which was sponsored by Senator Patrick Leahy, D-Vt, received support from a diverse array of lawmakers and industry stakeholders. The bill was cosponsored by Senators from both parties, including Amy Klobuchar, D-Minn., Mike Lee, R-UT., and Chuck Grassley, R-Iowa, and it received bipartisan support in Congress. It was also supported by the conservative group, FreedomWorks, as well as the liberal organization, Families USA, the American Hospital Association, and the Association for Accessible Medicines. The patient groups, Patients for Affordable Drugs NOW and Campaign for Sustainable Rx Pricing, insurers, Anthem and Kaiser Permante, and pharmacy/retailers, WalMart and CVS Health, were also in support of the bill.
Unsurprisingly, the main opposition came from big pharma. Companies that stand to lose from greater generic competition, along with PhRMA, the trade group responsible for representing companies in the pharmaceutical industry, have been lobbying hard against the measure. The CREATES Act would allow generic drug makers to take legal action against brand name manufacturers who withhold access to the samples generic makers need to replicate drugs. Big pharma argue that this would lead to increased litigation, and warn that reliance on litigation to remedy delays in generic entry is a slow, expensive, and unpredictable process that will drive up healthcare costs.
According to Will Holley, a spokesman for the Campaign for Sustainable Rx Pricing, it is disappointing that branded manufacturers have been able to influence governments decision making when it comes to the CREATES Act. Holley has said that he believes Congress has “missed an opportunity to pass this pro-competitive reform that would end some of the most egregious abuses by branded manufacturers and reduce drug prices for millions of Americans,”
Because the measure has not been included in the budget, it will remain a bill and will have to be passed in its own right, in order to become official legislation. To find out more about the specific provisions within the bill, check out WEP’s earlier article on the CREATES ACT.