Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for co…
This bill requires HHS to review brand-name drug prices at least annually and declares a drug "excessively priced" if the U.S. average manufacturer price exceeds the median price in Canada, the United Kingdom, Germany, France, and Japan, or based on other specified factors. For drugs found excessive, the Secretary must waive or void government-granted exclusivities, grant open non-exclusive licenses allowing others to make or import the drug and rely on regulatory data, and set reasonable royalties.
Whether voiding exclusivities is appropriate government action versus unlawful overreach
Relative to its intended legislative type, this bill is a detailed substantive policy proposal that sets clear goals and includes many specific mechanisms, statutory cross-references, and reporting/oversight elements, but it leaves critical implementation and resourcing details unresolved—particularly regarding enforcement of patent-related licenses, administrative appeals, and funding to support expanded HHS responsibilities.
This bill requires HHS to review brand-name drug prices at least annually and declares a drug "excessively priced" if the U.S. average manufacturer price exceeds the median price in Canada, the United Kingdom, Germany, France, and Japan, or based on other specified factors.
For drugs found excessive, the Secretary must waive or void government-granted exclusivities, grant open non-exclusive licenses allowing others to make or import the drug and rely on regulatory data, and set reasonable royalties.
The bill creates a public database, mandates detailed annual manufacturer reporting, authorizes prioritized FDA review for licensed generics/biosimilars, allows civil actions to recover revenue from post-determination price increases, and penalizes noncompliant manufacturers.
Substantial legal, industry, and policy resistance plus complex implementation make enactment unlikely absent major revisions or compromise.
Relative to its intended legislative type, this bill is a detailed substantive policy proposal that sets clear goals and includes many specific mechanisms, statutory cross-references, and reporting/oversight elements, but it leaves critical implementation and resourcing details unresolved—particularly regarding enforcement of patent-related licenses, administrative appeals, and funding to support expanded HHS responsibilities.
Whether voiding exclusivities is appropriate government action versus unlawful overreach
These are examples from the analysis, not a ranked list of the most-affected groups.
Whether voiding exclusivities is appropriate government action versus unlawful overreach
Strongly favorable: sees direct government action to lower drug prices by breaking monopolies and enabling competition.
Views mandatory reporting, public database, and royalty limits as accountability measures to protect patients.
Cautious support mixed with concern: appreciates goal of lower drug costs and transparency but worries about legal, administrative, and innovation tradeoffs.
Wants clearer safeguards for innovation and robust implementation plans.
Opposed: views statutory voiding of exclusivities and open licensing as government overreach undermining IP and market incentives.
Concerned about legal takings claims and adverse effects on innovation and international commerce.
Reached or meaningfully advanced
Reached or meaningfully advanced
Still ahead
Still ahead
Still ahead
Substantial legal, industry, and policy resistance plus complex implementation make enactment unlikely absent major revisions or compromise.
The bill has not accumulated any surfaced votes yet.
Whether voiding exclusivities is appropriate government action versus unlawful overreach
Substantial legal, industry, and policy resistance plus complex implementation make enactment unlikely absent major revisions or compromise.
Relative to its intended legislative type, this bill is a detailed substantive policy proposal that sets clear goals and includes many specific mechanisms, statutory cross-references, and reporting/oversight elements, b…
Go beyond the headline summary with full stakeholder mapping, legislative design analysis, passage barriers, and lens-by-lens tradeoff breakdowns.