Cicilline Bill to Lower Prescription Drug Costs to Become Law Today

Dec 20, 2019 Issues: Health Care

CREATES Act will make it easier for generic drugs to come to market, save taxpayers $3.9 billion, lower prescription costs by more than 80%


WASHINGTON – U.S. Congressman David N. Cicilline’s (RI-01) Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act (H.R.965) will be signed into law by the President today.


“In the last election, Democrats promised to bring down the high cost of prescription drugs. Today, we are delivering on that promise,” said Cicilline. “The CREATES Act cracks down on the big pharmaceutical companies that are charging an arm and a leg for medicine that thousands of Rhode Islanders, and millions of Americans, need. No longer will these companies be able to recklessly block or delay access to generic drugs that perform the same as branded drugs, at a fraction of the cost. This is a big win for American consumers, and another example of how Democrats are delivering for the people.”


Cicilline’s bipartisan legislation to bring down prescription drug costs was included as part of the federal spending bill that the House passed earlier this week and the Senate passed yesterday. President Trump is poised to sign the legislation into law later today.


According to an AARP report published earlier this year, high prescription drug prices have forced more than one out of five Rhode Islanders to stop taking medication as prescribed by their doctor. Over a five year period, from 2012 to 2017, the cost of name brand drugs used to treat cancer, diabetes, and heart disease rose substantially (67%, 61%, and 95%, respectively).


The Federal Trade Commission (FTC) and the Food and Drug and Administration (FDA) have conducted studies showing that generic competition saves American consumers billions of dollars each year by reducing the cost of prescription drugs by more than 85%. The Congressional Budget Office (CBO) estimates the CREATES Act will lower federal spending on prescription drugs by $3.9 billion.


Cicilline’s legislation ends abusive delay tactics that big pharmaceutical companies have used to block more affordable generic drugs from coming to market. Specifically, it:


  • Prohibits pharmaceutical companies from withholding samples of their drugs from generic competitors. Access to samples is a requirement for FDA approval of generic prescription drugs in order to demonstrate the medicine is equivalent.
  • Ensures generic competitors can participate in the FDA’s Risk Evaluation Mitigation Strategy with Elements to Assure Safe Use (REMS with ETASU) safety protocol. Pharmaceutical companies were previously able to block the participation of generic competitors.


Cicilline introduced the CREATES Act earlier this year with bipartisan support from the Ranking Members of the Judiciary Committee and the Antitrust Subcommittee, which Cicilline chairs. Judiciary Committee Chairman Jerry Nadler (NY-10) also co-sponsored the bill when it was introduced. The legislation is also endorsed by more than 90 organizations from across the political spectrum, including AARP, Public Citizen, and Social Security Works.