The Creating and Restoring Equal Access To Equivalent Samples (CREATES) Act passed in both the Congress and the Senate. Create lets a biosimilar or generic developer bring a civil action against an innovator drug company if the latter refuses to make available enough samples of a product for testing. Withholding samples is a method Pharma companies use to prevent innovation based on prior patents. It would also explicitly empower the FDA to approve alternative Risk Evaluation and Mitigation Strategy, or REMS, programs if a generic or biosimilar developer and the innovator company are unable to arrive at a single shared system.
Both objectives are intended to allow biosimilar and generic competition to enter the market sooner, thereby driving down drug prices for US patients.
This is another "win" for patients. Malecare along with much larger and more capable advocacy organizations like AARP and Patients For Affordable Drugs NOW are the drivers for this kind of legislation. Lets also cheer for the bi-partisan support from Senators Leahy, Rand Paul, R-Kentucky; Ted Cruz, R-Texas; Dianne Feinstein, D-California; and Amy Klobuchar, D-Minnesota, among others.
Together, we are helping to lower prescription drug prices, maintain innovation and create a world where effective drugs are affordable and accessible for all.
