Washington, D.C.—Today, Congressman Jim Sensenbrenner (WI-05) issued the following statement after Congress passed fiscal year 2020 appropriations bills:
“Our national debt recently passed $23 trillion, and Washington didn’t even blink. These appropriations bills fail to address our spending problem, and I could not in good conscience vote for either. However, one of the few positive provisions included in them is my bipartisan legislation to lower prescription drug prices – the CREATES Act. While I’m disappointed that Congress has passed up another opportunity to get our fiscal house in order, I am glad that Americans will have better access to more affordable medications.”
Background on the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act:
In order for a generic or biosimilar prescription to have FDA approval, the generic manufacturer must be able to compare its product to the brand-name product. Simply put, if the product is as safe and effective as the label, then the FDA can approve the generic.
Some generic manufacturers, however, have difficulty obtaining samples of medication from the brand-name company. This is because brand-name companies have an incentive to make it difficult for generic producers to obtain their brand-name products.
The CREATES Act gives generic manufacturers the ability to bring actions in federal court against brand-name companies that refuse to provide samples of their products for purchase and use in the generic approval process. In so doing, the CREATES Act helps to increase the likelihood of a generic product coming to the market so consumers have more affordable options.
The CREATES Act also gives the FDA more discretion for approving alternative safety protocols that meet the statutory standards already in place. This helps the FDA more efficiently process generic applications. In the end, this helps consumers, who will have more choices when selecting their medications.
According to a Congressional Budget Office estimate, the CREATES Act will save the federal government $3.9 billion on prescription spending.
More than 90 organizations representing consumers, physicians, pharmacists, hospitals, insurers, antitrust experts, and others support the CREATES Act. Supporters include AARP, Campaign for Sustainable Rx Pricing, Consumer Reports, Public Citizen, American Hospital Association, America’s Health Insurance Plans, Patients for Affordable Drugs, and the Coalition for Affordable Prescription Drugs.