Leaders Of Senate and House Judiciary Committees Reintroduce Bipartisan Legislation To Counter Rising Prescription Drug Prices

Top leaders on the Senate and House Judiciary Committees led by Senator Patrick Leahy on Thursday introduced legislation to combat anticompetitive practices used by some brand-name pharmaceutical and biologic companies to block entry of lower-cost generic drugs.  The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act would deter pharmaceutical companies from blocking cheaper generic alternatives from entering the marketplace.  The bill is sponsored by Leahy and cosponsored by Chairman Chuck Grassley (R-Iowa), Ranking Member Dianne Feinstein (D-Calif.), and by Senators Amy Klobuchar (D-Minn.) and Mike Lee (R-Utah), leaders of the Subcommittee on Antitrust, Competition Policy and Consumer Rights.  Lead sponsor, Representative Tom Marino (R-Pa.) and Representative David Cicilline (D-R.I.), Chairman and Ranking Member, respectively, of the House Judiciary Subcommittee on Regulatory Reform, Commercial and Antitrust Law, introduced an identical version of the bill in the House.

Leahy said:  “Vermonters and American families across the nation know from hard experience that many prescription drugs are simply too expensive.  Vermonters tell me that the high cost of prescription drugs has become their top health care concern.  When brand companies can drive up the price of drugs through predatory practices, patients suffer.  Illnesses worsen.  Families, government programs, and other payers in the healthcare system ultimately bear those added, unnecessary costs.  Strategies wielded by these firms to delay entry of lower cost generic drugs are wrong, and they cause real harm.  Drug affordability is a bipartisan issue that affects every American.  This needs to be a high priority.  I’m committed to working on behalf of Vermonters to see that the CREATES Act and other vital initiatives to address the high cost of prescription drugs are signed into law.”

“I frequently hear from Iowans about the high price of prescription drugs. Many Americans rely on more affordable generic medications once patents have expired for brand-name drugs,” Grassley said.  “Unfortunately, we’re seeing some brand-name drug companies engage in anti-competitive tactics that delay entry of lower cost generic drugs into the market.  This bill takes important steps to improve the current system so that consumers have access to less expensive generic drugs in a timely fashion.”

“When people get sick, their focus should be on getting well, not on how to pay for their prescriptions,” Klobuchar said. “Our bipartisan legislation would put an end to pharmaceutical company tactics that delay or prevent lower-cost competition while protecting patient safety and saving Americans consumers billions of dollars.” 

"Nearly everyone has a story about sticker shock at the pharmacy counter or anger at learning the drug they need isn’t covered by their health insurance,” Lee said. “Unfortunately, complex regulatory environments are being abused by some firms to avoid competition and keep prices high. Our CREATES Act aims to curb such regulatory abuse and facilitate generic entry, thereby lowering prices and increasing access while maintaining safety levels.”

Feinstein said: “The rapidly rising cost of prescription drugs, particularly those for cancer and chronic diseases, places a huge financial burden on patients and families nationwide. Ensuring generic drugs can get to market is one way to address this problem. Our bill would help put a stop to the unfair practices that block generic drugs from the market by giving companies legal avenues to challenge them.”

"As seniors struggle to pay for prescription drugs, pharmaceutical companies are raising the cost of drugs and making huge profits off of our nation’s most vulnerable populations. Speeding the entry of affordable and safe generic drugs into the market is a national priority that will lower prices through increased competition," said Cicilline. "The CREATES Act is a vital step in achieving this goal. By ending regulatory evasion and manipulation of safety protections through a well-tailored and cost-saving remedy, the CREATES Act will increase the number of affordable generic choices for consumers in the prescription drug market."

Marino said: “The CREATES Act will lead to lower costs for patients by ensuring that they have access to safe and effective FDA approved generic medicines.  It will also ensure consumer safety by maintaining safeguard features of the Risk Evaluation and Mitigation Strategies (REMS) Program while closing regulatory loopholes that are used to keep prices artificially high.”

The Congressional Budget Office has estimated that the bill would result in a $3.3 billion net decrease in the federal deficit.  Savings to consumers and private insurers likely would be far greater.

The legislation, a version of which was introduced in the House earlier this year, is strongly supported by the Association for Accessible Medicines (AAM), consumer groups including AARP, Consumers Union, and Public Citizen; the American College of Physicians; the American Hospital Association; the Campaign for Sustainable Rx Pricing; and America’s Health Insurance Plans (AHIP).

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

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