WASHINGTON, DC — During a noteworthy exchange at today’s Energy and Commerce Committee hearing, Health and Human Services Secretary Alex Azar publicly endorsed four legislative proposals to lower drug prices and help patients: curbing REMS abuses, ending pay-for-delay deals, banning evergreening, and ending sham Citizen Petitions.
“With the Trump Administration endorsing four common-sense solutions to address a problem eight out of 10 American voters agree must be solved, it’s time for Congress to act,” said Ben Wakana, Executive Director of Patients For Affordable Drugs Now. “Congress should pass these proposals immediately to crack down on anticompetitive behavior and stop insidious tactics that disrupt the free market and hurt patients.”
During today’s hearing, Secretary Azar told Democratic Congressman Peter Welch (VT), the administration supported legislation to fix:
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. Legislation 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.
EVERGREENING: Drug corporations often change drugs incrementally and patent the new product, which extends a corporations’ monopoly pricing power. For example, a company might move from a tablet to a capsule and apply for a new patent. This gaming of the system should not be permitted under U.S. law.
CITIZEN PETITIONS: Brand drug makers were behind 92 percent of all citizen petitions filed between 2011 and 2015 –– all aimed at blocking cheaper generic drugs. The FDA denied more than nine of every 10 of those petitions. Congress should stop sham citizen petitions.
Congressman Peter Welch: You do support, as I understand it, ending pay-for-delay. Is that the case?
Secretary Alex Azar: We do. In fact, our budget has a unique pay-for-delay provision in that if you do a pay-for-delay agreement, you would actually be penalized in the Medicare Part B system.
Welch: Right. And you want to curb the REMS abuses?
Azar: Absolutely do. So, the CREATES Act and working with you on that.
Welch: Right. And the product hopping that has been occurring is another way. Are you opposed to that as well?
Azar: I want to make sure I’m understanding.
Welch: It’s the abuse of Citizen Petitions, it’s product hopping, and other forms of evergreening.
Azar: Yes, we want to crack down on any forms of manipulation or evergreening of patents and exclusivity beyond what the original deals were.