Speier, Nadler, Porter Introduce Bill to Independently Value Drug Prices and Scrutinize Accelerated Approvals

Washington, DC - Today, Congresswoman Jackie Speier (CA-14), Congressman Jerry Nadler (NY-10), and Congresswoman Katie Porter (CA-45) 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.

"Patients shouldn't be forced to choose between paying their mortgage or rent and accessing vital medicines they depend on. They shouldn't have to go to the ER because they can't fork out as much for their prescriptions as they pay for utilities, gas, or groceries each month. Our bill - along with the Inflation Reduction Act - will do that by providing greater transparency when it comes to drug pricing calculations and having independent organizations recommend costs based on actual medical benefits, not corporate greed," Rep. Speier said. "It ensures drugs previously granted fast-tracked approvals or whisked through the approval process as breakthrough therapies are subject to the scrutiny patients need and deserve. And it would assess the effectiveness of at least 25 drugs that have already been FDA-approved, including drugs manufactured by Big Pharma companies that have unfairly exploited the patent process to aggressively hike prices. It's time for Congress to take control of the drug market so that it's safe and affordable for all Americans."

"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."

"What we have with prescription drugs is a broken market," Rep. Porter said. "Big Pharma should not be able to exploit patients and taxpayers for massive profits, especially when these big corporations cannot always demonstrate that their new products improve health outcomes. The Independent Drug Value Assessment Act will help prevent corporate abuse by verifying how much drugs actually benefit patients, taxpayers, and our health system."

The IndependentDrug 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).

"The Independent Drug Value Assessment Act would establish a much-needed process for evidence-based evaluation of drug benefits. In the United States, prescription drugs prices do not reflect the value provided to patients, and Big Pharma can charge what the market can bear," said Emily Gee, Vice President and Coordinator for Health Policy at CAP. "The recently passed Inflation Reduction Act will bring lower drug prices for seniors on Medicare and rein in drug makers' price hikes, and Rep. Speier's proposal would complement those reforms by subjecting all drugs with new approvals or newly approved indications to value assessment, as well as bring greater scrutiny to accelerated approval drugs without clinically meaningful benefit."

A copy of the bill text is attached below.

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Related Files

• Independent Drug Value Assessment Act - Bill Text.pdf(130.8 KBs)

Permalink: https://speier.house.gov/2022/11/speier-nadler-porter-introduce-bill-to-independently-value-drug-prices-and-scrutinize-accelerated-approvals