Schrader, Carter Introduce Bipartisan Bill to Keep Drug Costs Down
Following the House Committee on Oversight and Reform hearing on prescription drug pricing earlier this week, Congressman Kurt Schrader (D-OR) and Congressman Earl L. "Buddy" Carter (R-GA) today introduced legislation aimed at keeping drug prices down by increasing competition in the generic drug market.
Current law awards 180 days of exclusivity on the market to a drug manufacturer when they are the first to file a generic drug application with the FDA for a drug for which there is no generic. The purpose of this award is to reward manufacturers for challenging weak patents and bringing new low-cost drugs to the market. The 180 days begins once the manufacturer starts marketing the drug, but even before the manufacturer begins marketing, all other generic competitors are blocked from coming to market. This allows some manufacturers to “park” the exclusivity before receiving final approval, blocking competition for more than the 180 days intended by the law. In these cases, no other generics are able to come to the market until the first manufacturer receives final approval, begins marketing the drug, and the subsequent 180 days have passed.
The Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act would stop first generic drug “parking.” Under the BLOCKING Act, if a second generic drug application is blocked from receiving approval solely due to a first generic drug manufacturer parking their exclusivity at the tentative approval stage, the 180 days immediately begins to run, preventing limitless delays for other generics to come to the market. This legislation mirrors a proposal to “speed development of more affordable generics to spur competition” that was included in the administration’s FY19 budget proposal.
“Too many patients across this country feel a severe impact from rising drug prices, often on prescriptions they’ve been filling for years,” said Rep. Schrader. “I have long said there is not one silver bullet solution to this crisis, however, we do know that increasing competition on the drug market places a check on manufacturers and keeps costs down. Our bill is one such solution that targets and eliminates unnecessary delays in allowing more drugs on the market, ensuring both that manufacturers are still incentivized to produce more drugs and that markets continue to see robust competition.”
“As the only pharmacist in Congress, one of my top priorities is making prescription drugs more affordable and accessible,” said Rep. Carter. “I am happy to introduce this bill today with my friend Representative Schrader because it will work to bring more generic competition into the marketplace faster. More competition will help make these drugs more affordable and accessible for patients. This proposal has support from President Trump and bipartisan members of Congress. I hope it will move through Congress as soon as possible for the benefit of all patients.”
Congressman Schrader has long been committed to lowering drug costs. During the 114th Congress, he introduced a bill to prevent price hikes to lifesaving drugs after Turing Pharmaceuticals, led by hedge fund manager Martin Shkreli, jacked the price of Daraprim – an anti-parasitic drug that’s most commonly used to treat and prevent certain infections in HIV positive patients – from $13.50 to $750 overnight. In 2017, a version of that legislation passed as part of the FDA Reauthorization Act of 2017, and last summer, his law saw its first successeswhen several strengths of potassium chloride oral solution, used to treat low potassium blood levels in patients who are on diuretics, that did not have generic versions available received a Competitive Generic Therapy (CGT) designation – a classification established under the law – allowing the medication to come to market faster. Several more CGTs have since come to market.
Tags: Health Care