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Baldwin’s Bills to Increase Prescription Drug Transparency and Boost Access to Treatments for Rare Diseases Advance in Senate

Bipartisan FAIR Drug Pricing Act requires basic transparency for pharmaceutical corporations that increase drug prices Bipartisan RARE Act preserves access to treatments for rare disease patients, especially children

WASHINGTON, D.C. – Today, two bills led by U.S. Senator Tammy Baldwin (D-WI) passed out of the Senate Committee on Health, Education, Labor and Pensions with Democratic and Republican support and now head to the full Senate for a vote. The Fair Accountability and Innovative Research (FAIR) Drug Pricing Act requires basic transparency for pharmaceutical corporations that increase drug prices. The Retaining Access and Restoring Exclusivity (RARE) Act will help preserve access to treatments for rare disease patients, especially children, by incentivizing drug manufacturers to research and develop these treatments. Both pieces of legislation were included in a bipartisan package of bills that aim to lower the cost of prescription drugs for Americans.

“Big drug companies are jacking up the prices on Wisconsin families and turning record profits, all while Wisconsinites are struggling to afford the cost of the medication they need to stay healthy and alive. Today, working with my Democratic and Republican colleagues, we took a step forward to help lower the costs of prescription drugs, hold big pharma accountable, and make drug companies explain to Americans why they are raising prices on working families,” said Senator Baldwin.

From July 2021 to July 2022, the price of more than 1,200 medications increased greater than inflation – with an average increase of almost four times the inflation rate – and the median annual price of a new drug in 2022 costing more than $222,000. While big drug companies took in record profits, more than one quarter of Americans struggle to pay for their prescription medications and over 15 percent of patients report either delaying a refill after running out of medications or rationing medications due to cost.

The FAIR Drug Pricing Act would require drug manufacturers to notify the U.S. Department of Health and Human Services (HHS) and submit a transparency and justification report 30 days before they increase the price of drugs that cost at least $100 by more than ten percent over one year or 25 percent over three years. For drugs that have a list price that is higher than median family income, or $70,784 in 2021, manufacturers will also be required to submit a transparency and justification report.

The RARE Act responds to the 2021 U.S. Court of Appeals decision in Catalyst Pharms., Inc. v. Becerra that weakened the Orphan Drug Act of 1983 and disincentivized development into drugs to treat rare diseases. The court ruled in favor of Catalyst Pharmaceuticals, Inc., turning a decades-long practice by the Food and Drug Administration (FDA) regarding “orphan drug exclusivity” on its head. An orphan drug is used to treat an orphan disease, a rare disease or condition that affects fewer than 200,000 people. As a result, FDA was forced to withdraw marketing approval for a drug that provides the only approved treatment option for children with a rare disease called Lambert-Eaton myasthenic syndrome, or LEMS.

The bipartisan RARE Act would fix this issue by codifying the FDA’s longstanding interpretation of the Orphan Drug Act of 1983 to ensure that the scope of the orphan drug exclusivity is clarified to apply only to the same approved use or indication within such rare disease or condition instead of the same disease or condition. This would give FDA the necessary authority to approve the same drug from different manufacturers if they aim to serve different patient populations and combat manufacturers’ efforts to take advantage of the Court’s ruling in Catalyst.

A one-pager on the FAIR Drug Pricing Act can be found here and on the RARE Act can be found here.