WASHINGTON, DC — Organizations representing patients and the research and development community today sent a letter urging Congressional leaders to pass the CREATES Act. Friends of Cancer Research, the National Multiple Sclerosis Society, and Patients For Affordable Drugs encouraged Congress to act soon to pass the bipartisan legislation that will help drive down drug prices by speeding generics to market and protecting the safety of patients.
“As groups dedicated to serving patients, we encourage Congress to address REMS abuses so generic drugs come to market on time and brand manufacturers invest in innovative, life-saving new drugs, rather than milking profits from drugs that should have generic competition,” the organizations wrote.
The letter, to Speaker Ryan, Majority Leader McConnell, and Minority Leaders Schumer and Pelosi, tells the story of Barton Fisk, a 60-year-old father of three from Alabama who has multiple myeloma and pays $12,000 per-year for a drug called Revlimid, which keeps him alive. Fisk has multiple sclerosis, too, but can’t afford the drugs for both conditions, so he lets the MS progress.
Revlimid’s maker, Celgene, refused to provide samples to generic manufacturers looking to create a competitor. Along the way, Revlimid’s wholesale price doubled to $18,546 from $9,853 in 2010.
Congress has a chance to help people like Fisk, and momentum to do so continues to build.
Recently, Senator Ted Cruz and Rand Paul added their support by cosponsoring the legislation which the Congressional Budget Office estimates would save taxpayers $3.3 billion over the next decade. Cruz and Paul join a bipartisan group of senators including Patrick Leahy, Chuck Grassley, Mike Lee, Amy Klobuchar, John McCain, and Dianne Feinstein, among others.
In addition to today’s letter, Patients For Affordable Drugs launched a national campaign in October to push for the bill’s passage. Since then, the organization has testified before Congress, sent scores of patient letters, and brought patients to Washington to meet with their representatives.
Full text of the letter is below:
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The Honorable Paul Ryan
Speaker of the House
United States Senate
1233 Longworth House Office Building
Washington, D.C. 20515
The Honorable Mitch McConnell
Majority Leader
United States Senate
317 Russell Senate Office Building
Washington, DC 20510
The Honorable Charles Schumer
Minority Leader
United States Senate
322 Hart Senate Office Building
Washington, DC 20510
The Honorable Nancy Pelosi
Minority Leader
United States Senate
235 Cannon House Office Building
Washington, DC 20515
Dear Speaker Ryan and Leaders McConnell, Pelosi, and Schumer,
As organizations that represent patients and the research and development community, we urge you to pass the CREATES Act as soon as possible. It will help drive down drug prices by encouraging competition and speeding generics to market while protecting the safety of patients.
This legislation would provide significant relief to Americans struggling under high drug costs. Here’s an example: Barton Fisk is a 60 year-old father of three from Vestavia, Alabama. He’s currently fighting blood cancer and multiple sclerosis. Barton cannot afford to take any drugs to treat his multiple sclerosis because he pays $12,000 per year out-of-pocket for Revlimid, a cancer drug made by Celgene.
Using safety as a pretext to misuse risk evaluation and mitigation strategies (REMS), Celgene refused to provide product samples of Revlimid to generic competitors looking to bring a cheaper generic to market. Mr. Fisk and thousands of patients like him are paying the price. The FDA reports that it has received more than 150 letters in the past few years from generic manufacturers seeking help with this issue.
The CREATES Act will address these abuses and encourage generic drug competition. It achieves this while protecting patient safety. Both the Federal Trade Commission and the Food and Drug Administration are in favor of stopping REMs abuses. FDA Commissioner Scott Gottlieb told drug companies to “end the shenanigans.” But the FDA lacks authority to compel action or impose sufficient sanctions. Congressional action is needed.
When drug companies game our system, find loopholes, and operate outside of Congressional intent in order to extend patents to prevent generic competition, they are not focused on developing new life-saving treatments. As groups dedicated to serving patients, we encourage Congress to address REMS abuses so generic drugs come to market on time and brand manufacturers invest in innovative, life-saving new drugs, rather than milking profits from drugs that should have generic competition.
The CREATES Act enjoys support from a bipartisan group of senators including Chuck Grassley, Mike Lee, Rand Paul, Ted Cruz, John McCain, Patrick Leahy, Amy Klobuchar, and Dianne Feinstein.
In the interests of patients all across this country, we urge enactment of the CREATES Act. It will foster competition while protecting drug safety and lead to lower drug prices for all Americans. Patients are hurting now, and they need your help.
Sincerely,
Friends of Cancer Research
National Multiple Sclerosis Society
Patients For Affordable Drugs
