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Exploring the Biden Administration's Proposed Framework on March-in Rights for High-priced Drugs

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Mason Walker
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Exploring the Biden Administration's Proposed Framework on March-in Rights for High-priced Drugs

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Biden Administration's Proposed Framework on March-In Rights

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In an attempt to address the issue of high drug prices in the United States, the Biden Administration has proposed a framework to provide guidance to government agencies about the use of march-in authorities. The Departments of Health and Human Services and Commerce have been reviewing the government's march-in authorities as part of a monthslong effort under the Bayh-Dole Act of 1980. The proposed framework clarifies that this existing authority can be used if a government-funded drug's price is considered too high, a power that the National Institutes of Health has declined to exercise for many years.

Unlocking the Potential of March-In Rights

The Biden Administration's move aims to enable the government to license certain patents of high-priced drugs to other companies, thus enabling them to sell the drugs at lower prices. The administration believes this could be a potential solution to the longstanding issue of high drug prices. The proposed framework will be open to public comment for 60 days, as reported by CNBC, Politico, Reuters, Forbes, and CNN.

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Opposition and Concerns

However, not everyone is in agreement with the administration's proposal. Critics argue that march-in rights were never intended for curbing high prices. They believe that reinterpreting the law in this way could have dangerous consequences for innovation in the pharmaceutical industry, which relies heavily on patent protection to fund research and development.

International Drug Price Disparities Remain Unaddressed

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Another aspect that the proposed framework does not address is the significant disparity in drug prices in the U.S. compared to other countries. While the framework may potentially lower prices domestically, it does not offer a solution to the global issue of high drug prices.

Next Steps and Public Participation

The Biden Administration has not yet announced any specific drugs whose patents it intends to march in on. As the proposal is still in the early stages, the public is encouraged to provide feedback over the next 60 days. This period of public comment is a critical part of the process, allowing for a range of perspectives to be considered before any final decisions are made.

Looking Forward

The Biden Administration's proposed framework marks a significant step in the ongoing effort to tackle high drug prices in the United States. While it is not without its critics, the move signifies a commitment to exploring all available options. As the conversation progresses, the potential impact of these march-in rights on the pharmaceutical industry and drug prices will continue to be a topic of close attention and scrutiny.

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