Welch authors bill to stop brand name abuse of FDA approval process

Submitted by tim on Tue, 04/30/2019 - 10:42

Big Pharma companies filing sham public comments to thwart approval of generic drugs

Vermont Buisness Magazine Representative Peter Welch (D-Vermont) joined a bipartisan group of House and Senate members yesterday in introducing legislation to stop brand name drug company abuse of the drug approval process in order to block or slow more affordable generic drugs from coming to market. The Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics (Stop STALLING) Act would curb the common brand company practice of filing sham “citizen petitions” during the drug approval process that masquerade as public comments.

“Too many Vermonters, particularly seniors, cannot afford their prescription drugs,” said Welch. “It is simply outrageous that brand drug companies are manipulating the drug approval process to slow or block approval of more affordable generic alternatives. Our bill will stop this blatantly anti-competitive abuse.”

The Stop STALLING Act (H.R. 2374/S. 1224) would:

• Create an FTC cause of action against sham petitions as unfair methods of competition,

• Create a rebuttable legal presumption of illegality for certain petitions referred from the FDA with a finding that they were submitted for the primary purpose of delaying the approval of a drug application, and

• Grant the FTC the authority to seek civil penalties for violations.

The bill is sponsored in the House by Rep. Welch, Rep. Jeffries (D-N.Y.), Rep. Collins (R-Ga.), and Rep. Sensenbrenner (R-Wis.). Senate sponsors are Sen. Klobuchar (D-Minn.) and Sen. Grassley (R-Iowa).

Welch, a member of the powerful Energy and Commerce Committee, is a House leader on efforts to make prescription drugs more affordable. Just last month he ushered the CREATES Act (H.R. 965) through the Committee which will lower prescription drug prices by bringing generic drugs to market faster. The full House is expected to pass the CREATES Act next month.

Source: Welch 4.30.2019