Mike Enzi: “I ask the body to vote no on the Edwards amendment to increase drug costs. This is a new drug approval. The amendment…”

“I ask the body to vote no on the Edwards amendment to increase drug costs. This is a new drug approval. The amendment masquerades as a direct-to-consumer advertising amendment while sweeping away carefully calibrated FDA drug approval standards. While the Edwards amendment masquerades as an amendment to "strengthen protections against misleading direct-to-consumer advertising," the amendment drastically changes the requirements for drug approval in the United States. We have a great system that is working. Under the current law, pharmaceuticals must demonstrate they are safe and effective to be approved by the Food and Drug Administration. Under the Edwards amendment, the Secretary of Health and Human Services would be authorized to vary this standard on a drug-by-drug basis to create new hurdles to drug approvals. These new hurdles include lengthy, costly comparative trials and a showing that the drug is safer or more effective for a subpopulation or condition than a previously approved drug. These changes to fundamental, longstanding law could hurt patients by delaying, and possibly denying, the approval of new drugs that patients need; by dramatically adding to drug development costs, discouraging companies from developing additional drugs to treat the same conditions; and increasing drug spending by reducing brand-to-brand competition.”