U.S. Senator and physician Rand Paul has introduced S. 3466, the Accelerating New Pharmaceutical Competition Act, to reduce red tape at the Food and Drug Administration (FDA) by fast tracking FDA approval of medicines and devices that have met safety and efficacy standards in other developed nations. Unnecessary bureaucratic delays have kept more EpiPen alternatives off U.S. markets, contributing toward a virtual monopoly over auto-injected epinephrine and further inflating the treatment’s prices.
“Competition is essential to expanding access to a wider variety of affordable options for patients,” said Dr. Paul. “Treatments proven by rigorous testing in other developed countries to be effective and safe shouldn’t have to jump redundant hurdles to get to U.S. markets. Congress can immediately address the massive spikes in prescription drug prices by passing this legislation.”
You can find the text of the Accelerating New Pharmaceutical Competition Act HERE. You can find a summary of the bill’s provisions below.
The Accelerating New Pharmaceutical Competition Act, S. 3466
- Allows sponsors of drugs approved in Europe and other developed countries to be able to show safety and efficacy to the FDA without repeating lengthy and costly clinical trials.
- Requires the FDA to act on these foreign-approved applications within 90 days, or the drug product is presumed to be approved and may come to market.
- Removes the automatic 30-month stay of market approval for generic drug applications that are the subject of ongoing patent litigation. Rather, the bill would give full authority to the court to determine whether to shorten or lengthen such a stay.
- Fast tracks the approval of generic drugs in cases where there is a sole source or limited competition by requiring the FDA to act on those applications within 150 calendar days.
WATCH: HELP Subcommittee Hearing on “EpiPen Price Increases” – Oct. 7, 2016