WASHINGTON, DC — In response to the House Energy and Commerce Committee passing the CREATES Act and legislation to end pay-for-delay tactics, David Mitchell, a cancer patient and the founder of Patients For Affordable Drugs Now, issued the following statement:
“Many Americans have lost faith in Congress’s ability to fix problems. Today, the Energy and Commerce Committee proved that small but important bipartisan reforms are still possible. I appreciate Chairman Pallone, Ranking Member Walden, and members on both sides of the aisle for working on one of the most critical issues facing Americans — skyrocketing prescription drug prices.
“Today’s actions must be the first step by this Congress on the path to lower drug prices, not the last. Even when these bills are signed into law, Americans will still go into debt at the hands of drug companies.
“More action is required to fix our broken system and lower prescription drug prices. We look forward to working with Congress to see further reforms enacted.”
REMS ABUSES: Brand drug companies use a safety program called Risk Evaluation and Mitigation Strategies (REMS) as a pretext for not selling drug samples to generic companies, which need the brand product in order to develop an equivalent and lower-priced competitor. The CREATES Act would address delay tactics that are used by brand drug manufacturers to block lower-priced generic drugs. The U.S. could save $3.9 billion by stopping this abuse, which the FDA has called “unfair and exploitative.”
PAY-FOR-DELAY: Brand drug companies pay off generic companies that plan to bring a competitor to market. In exchange for this payment, the generic manufacturer delays its product’s entry into the market. HR 1449, the Protecting Consumer Access to Generic Drugs Act would limit deals in which brand and generic drug manufacturers use anti-competitive pay-off agreements to delay cheaper generic and biosimilar drugs from reaching patients.
Celgene’s cancer medication, Revlimid, tops a list maintained by the FDA that highlights which brand pharmaceutical corporations are blocking generic competition. The maneuver puts patients like Pam Holt’s life and financial wellbeing at risk. The cancer patient took on $10,000 in debt and refinanced her home to afford Revlimid, telling Patients For Affordable Drugs:
“Celgene, the company that makes Revlimid, should be giving samples to generic drug makers so they can make a cheaper version, but it repeatedly refused to do so. Celgene is abusing a loophole in our laws to keep the price high. The company keeps raising the price simply because it can. And, I keep taking on debt.”