Today, Congressman Jerrold Nadler (NY-12) and Congresswoman Katie Porter (CA-47) introduced a bill to ensure fair prices for prescription drugs by establishing an independent, evidence-based process for evaluating drug benefits and pricing. The legislation would advance much-needed oversight and robust analyses of drugs that are granted FDA approval. The Independent Drug Value Assessment Act would work in conjunction with the recently passed Inflation Reduction Act to ensure lower drug prices and greater transparency for patients and consumers.

“Year after year, pharmaceutical companies get away with charging exorbitant prices for drugs without demonstrating the true value of these medicines for patients, jeopardizing the health and well-being of millions of Americans,” Rep. Nadler said. “By informing drug price negotiations with evidence-based assessments of the actual benefits of FDA-approved medicines, the Independent Drug Value Assessment Act will help prevent corporate abuse and ensure that prices reflect the real value of drugs to patients, caregivers, and taxpayers.”

“Big Pharma’s well-documented greed hurts patients who struggle to get affordable, effective treatments,” said Rep. Porter. “Our prescription drug market is broken and in desperate need of oversight and accountability. Independently verifying the benefits of new prescription drugs—and pricing the medications accordingly—will give Americans confidence they aren’t getting ripped off by Big Pharma.”

The Independent Drug Value Assessment Act would account for the benefits of a particular drug for an average patient, then compare those benefits with those provided by other potential treatments. Such analyses would include both direct benefits to the patient (for example, improved quality and duration of life) and indirect benefits (for example, improvements to the patient’s earnings capacity, benefits to caregivers, or savings for the health care system). Each independent assessment would be publicly available for negotiating parties to use if they wish, providing valuable data to help with drug pricing negotiations.

Further, HHS would contract with third-party organizations to carry out the assessments. These organizations may include:

• Non-profit organizations.
• Federally funded research and development centers.
• Universities.
• Other organizations deemed appropriate by HHS.

To prevent conflicts of interest, the assessments may not be conducted by entities that could manipulate assessments for profit, including drug manufacturers, pharmacy benefit managers, or health insurers.

Prescription drugs that would undergo this value assessment include:

• Each newly approved drug after enactment.
• Each drug for which a new use is approved after enactment.
• At least 25 drugs approved before enactment, with priority placed on:
• Drugs in the top 35% of Medicare expenditures.
• Drugs approved as a breakthrough therapy, designated as a fast-track product, or granted accelerated approval.

The Independent Drug Value Assessment Act is supported by the Center for American Progress (CAP).

"Drug prices in the U.S. aren’t reflective of their value to patients, and we need a system to verify that prescription drugs are truly delivering the benefits that Big Pharma promises," said CAP Senior Vice President for Inclusive Growth Emily Gee. "The Independent Drug Value Assessment Act would help fix that. All Americans deserve fair prices for the medications they need."

The text of the bill can be found here.