House Appropriations Committee passes CREATES Act

The House Appropriations Committee on Tuesday evening passed H.R. 965, "Creating and Restoring Equal Access to Equivalent Samples,” or CREATES Act of 2019, as part of a package. The bill is now headed to the Senate.

The CREATES Act was first introduced in February of 2019. In April 2019, The House Energy and Commerce Committee unanimously passed the bill by a vote of 51-0.

The bill, which was introduced by Reps. David Cicilline, D-R.I., Jim Sensenbrenner, R-Wis., Jerrold Nadler, D-N.Y., Doug Collins, R-Ga., Peter Welch, D-Vt., and David McKinley R-W.Va., would establish a process by which generic manufacturers could obtain sufficient quantities of brand drug samples for testing thereby deterring gaming of safety protocols that brand manufacturers use to delay or impede generic entry.

The Association for Accessible Medicines issued a statement today which said, “AAM applauds passage of the CREATES Act, which will lower drug prices for patients through increased competition and by stopping the abuse of FDA’s safety programs and non-FDA mandated closed distribution systems. With the support of more than 90 organizations, this bipartisan, market-based solution will reduce spending on prescription drugs by an estimated $13.4 billion each year.”

The AAM went on to say, “We greatly appreciate the bipartisan effort to lower the cost of prescription drugs through advancement of the CREATES Act.”