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Shrader: Blocking Act opens drug competition

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Congressman Kurt Schrader Press Release,

The House Energy and Commerce Health Subcommittee marked up and passed a series of bills aimed at lowering prescription drug costs, including Congressman Kurt Schrader (D-OR) and Congressman Earl L. “Buddy” Carter (R-GA)’s bipartisan BLOCKING Act, HR 938 [3], that would increase competition in the generic drug market.

“We know that when generic versions of medication are on the market it stimulates competition and keeps the cost of drugs down for everyone,” said Rep. Schrader. “But generic drugs don’t save anyone money if they aren’t on the market. Our bill targets and eliminates unnecessary delays in allowing more drugs to get to the market by ensuring both that manufacturers are still incentivized to produce more drugs and that markets continue to see robust competition. I want to thank my colleague, Buddy Carter, for his work on this, and for all of my colleagues for their support today.”

“I am very glad to see this legislation approved by the subcommittee today because it will work to bring more generic competition into the marketplace faster,” said Rep. Carter. “More competition is critical in order to lower the costs of prescription drugs for patients. I want to thank my friend Kurt Schrader for working with me to make prescription drugs more affordable and accessible.”

Reps. Schrader and Carter introduced the Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act earlier this year to stop first generic drug “parking.” 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.

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 proposa [4]l.

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