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Improved Access to Affordable Medications Act
12/15/2023, 4:07 PM
Summary of Bill S 1120
One key provision of the bill is the establishment of a Prescription Drug Affordability Board, which would be responsible for setting limits on the prices of certain prescription medications. This board would work to ensure that drug prices are reasonable and affordable for consumers, while also taking into account the need for pharmaceutical companies to recoup their research and development costs.
Additionally, the bill includes measures to increase competition in the pharmaceutical industry, such as allowing for the importation of cheaper prescription drugs from other countries and promoting the development of generic alternatives to brand-name medications. These measures are intended to drive down prices and make medications more affordable for consumers. Furthermore, the Improved Access to Affordable Medications Act includes provisions to increase transparency in the pricing of prescription medications. Pharmaceutical companies would be required to disclose information about the costs of producing and marketing their drugs, as well as any financial assistance programs available to help consumers afford their medications. Overall, Bill 118 s 1120 seeks to address the issue of high prescription drug prices in the United States by increasing access to affordable medications for all Americans. The bill aims to achieve this goal through a combination of price controls, increased competition, and greater transparency in the pharmaceutical industry.
Congressional Summary of S 1120
Improved Access to Affordable Medications Act
This bill modifies provisions relating to the ability of generic drug manufacturers to obtain samples of brand-name drugs for purposes of generic drug development.
Under current law, brand-name drug manufacturers must provide sufficient quantities of their products on commercially reasonable, market-based terms to generic drug manufacturers upon request for purposes of generic drug development. Brand-name drug manufacturers are subject to civil actions if they fail to do so. The bill modifies provisions relating to this requirement and the criteria needed for related civil actions, such as specifying that generic drug manufacturers may use certain delivery services to make their requests.
Additionally, under current law, generic drug manufacturers must obtain authorization from the Food and Drug Administration (FDA) in order to request sufficient quantities of brand-name drugs that are subject to a Risk Evaluation and Mitigation Strategy (REMS) with elements to ensure safe use (ETASU). The bill requires the FDA to approve an authorization request within 60 days (rather than 120 days), if testing and development does not involve human clinical trials. (The FDA sometimes requires a REMS program for certain drugs with safety risks, which may include restrictions on a drug's distribution through ETASU, such as special requirements for pharmacies that dispense the drug.)
The bill also requires brand-name drug manufacturers to post their policies on evaluating and responding to requests from generic drug manufacturers for their products, including relevant contact information and procedures.
