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Schrader Issues Statement Following FDA's Budget Request Includes His Proposal To Close Loophole in Generic Drug Approval Process

U.S. Congressman Kurt Schrader (OR-05) issued the following statement in response to the FDA’s budget request for the President's FY23 budget that includes a proposal to amend the process for beginning the clock on the 180-day exclusivity period for being the first generic to market to encourage timely entry of third and fourth competitor, generic drugs:

“I am pleased to see the President recognize the importance of this timely, important policy that I have championed for the last three Congresses. His request prioritizes the need to amend current law surrounding the 180-day exclusivity incentive that we provide the first manufacturer bringing a generic to market for any given brand drug. For far too long, manufacturers have found a workaround in current law with the 180-exclusivity period for first generic drugs by making technical changes during the approval process or delaying their final approval extending their 180-day period where they have market access without additional competition,” Rep. Schrader said. “By addressing this, we can work to bring more generic drugs to market in a timely manner while also boosting competition and incentivizing innovation. The data shows that increasing competition between third and fourth products greatly reduces the cost of drugs. Closing this loophole will significantly reduce drug costs for all Oregonians.”

Congressman Schrader has long been a champion of meaningful drug pricing policies that drive down costs while protecting our nation’s ability to produce life saving medications and cures. Earlier this Congress, Schrader re-introduced H.R.2853, the Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act, legislation that would be an alternative solution to address the current 180-day patent challenge exclusivity provisions.

The BLOCKING Act would eliminate the "parking” of drug applications that manufacturers employ to extend their exclusivity when a second generic drug is ready to come to market, the 180-day exclusivity window for the first generic drug manufacturer begins to run.

The BLOCKING Act has been referred to the Energy and Commerce Health Subcommittee where it awaits further action.

Bill text of the BLOCKING Act can be found HERE.

More information about the President's FY23 FDA budget request can be found HERE.