Washington, D.C. — U.S. Senators Susan Collins (R-Maine) and Angus King (I-Maine) announced that legislation they cosponsored to combat anticompetitive practices used by some brand-name drug companies to block entry of lower-cost generic drugs has been signed into law.  The Creating and Restoring Equal Access To Equivalent Samples (CREATES) Act will deter pharmaceutical companies from blocking cheaper generic alternatives from entering the marketplace.  The CREATES Act was included as part of the final appropriations package.

“Skyrocketing drug prices are making it more and more difficult for Americans to access the treatments they require.  As Chairman of the Senate Aging Committee, addressing the rising costs of these medications is one of my top priorities,” said Senator Collins.  “The CREATES Act combats the gaming that some brand companies engage in to unlawfully extend their market power and pricing controls.  This bipartisan bill will have an immediate impact on the development and approval of generic and biosimilar drugs.”

“The rising cost of prescription medication continues to be one of the most pressing issues facing Maine people,” Senator King said. “Whether it’s a senior on a fixed income, or a working family trying to make ends meet, or an employer paying for private insurance, these prices are a serious challenge for Maine people across our state. Increased access to generic medications will help Maine citizens take care of their health without having to sacrifice other important necessities – because no one should be forced to choose between taking an important medicine or putting food on the table.”

The Congressional Budget Office has estimated that the bill would result in a $3.9 billion net decrease in the federal deficit.  Savings to consumers and private insurers likely would be far greater – many billions of dollars more.

The legislation is strongly supported by a broad coalition of groups, including AARP, American College of Physicians, Coalition for Affordable Prescription Drugs, and many others. A coalition letter in support of the CREATES Act can be found here and a list of supporters here.

In addition to Senators Collins and King, the CREATES Act was introduced by Senators Patrick Leahy (D-Vt.), Chuck Grassley (R-Iowa), Amy Klobuchar (D-Minn.) and Mike Lee (R-Utah), Dianne Feinstein (D-Calif.), Tammy Baldwin (D-Wis.), Richard Blumenthal (D-Conn.), Cory Booker (D-N.J.), Sherrod Brown (D-Ohio), Tom Cotton (R-Ark.), Ted Cruz (R-Texas), Steve Daines (R-Mont.), Dick Durbin (D-Ill.), Joni Ernst (R-Iowa), Deb Fischer (R-Neb.), Maggie Hassan (D-N.H.), John Kennedy (R-La.), Bob Menendez (D-N.J.), Lisa Murkowski (R-Alaska), Rand Paul (R-Ky.), Mike Rounds (R-S.D.), Tina Smith (D-Minn.), Debbie Stabenow (D-Mich.), Jon Tester (D-Mont.), Sheldon Whitehouse (D-R.I.) and Todd Young (R-Ind.).

An outline of the CREATES Act can be found here, and text of legislation can be found here.

In 2015, Senator Collins and then-Senator Claire McCaskill (D-MO) launched the Senate’s first bipartisan investigation into the causes, impacts, and potential solutions to egregious price spikes for certain off-patent drugs.  They released a report on their investigation in 2016.  Following their investigation, Senators Collins and McCaskill authored a bill to improve generic competition and lower the cost of prescription drugs that was signed into law as part of the FDA Reauthorization Act.  In October 2018, Senator Collins’ legislation to prohibit the use of pharmacy “gag clauses” was also signed into law.  Senator Collins is a cosponsor of the Safe and Affordable Drugs from Canada Act of 2019, legislation to permit the importation of prescription drugs from approved pharmacies in Canada.

In January, Senator King announced his support for three bills that would reduce the cost of prescription drugs. The first bill, the End Taxpayer Subsidies for Drug Ads Act, would prohibit pharmaceutical drug manufacturers from claiming tax deductions for consumer advertising expenses, and the Affordable and Safe Prescription Drug Importation Act would allow patients, pharmacists and wholesalers to import safe, affordable medicine from Canada and other major countries. The Empowering Medicare Seniors to Negotiate Drug Prices Act would allow for Medicare to negotiate the best possible price of prescription drugs to cut costs for nearly 43 million seniors enrolled in Medicare Part D. Current law only allows for bargaining by private plan sponsors and prohibits Medicare from doing so.