WASHINGTON – Top leaders on the Senate and House
Judiciary Committees led by Senator Patrick Leahy (D-Vt.) 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. Representatives David Cicilline (D-R.I.) and Tom
Marino (R-Pa.), leaders 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.
-30-