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Biden Administration Proposes Framework for Asserting March-In Rights to Address High Drug Prices

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Dr. Jessica Nelson
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Biden Administration Proposes Framework for Asserting March-In Rights to Address High Drug Prices

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The Biden administration has recently laid out a framework that would allow it to assert 'march-in rights' to seize the patents of high-priced drugs developed with taxpayer funds. This strategy is part of a larger effort to address the issue of soaring drug prices, a key objective in President Biden's healthcare agenda and reelection campaign.

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Understanding March-in Rights

The concept of 'march-in rights' stems from the Bayh–Dole Act of 1980, which allows the government to grant licenses to other companies to produce high-priced drugs that were developed using taxpayer dollars. If the original drug developers refuse to make their products 'reasonably' available, invoking these rights enables the government to maintain access to these crucial medications at a lower cost.

Restrained Use of March-in Rights

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While the Biden administration has confirmed its authority to use march-in rights, it has also clarified that it does not plan to endorse widespread use of this policy or target specific drugs. However, the administration has released a framework recommending factors federal agencies should consider when deciding to use these rights. Importantly, the price of a medication can be a factor in this decision.

The Proposed Framework

Issued by the Commerce Department, the proposed framework allows federal agencies to consider various factors when deciding to invoke march-in rights. This includes whether only a narrow set of patients can afford the drug, or if drugmakers are exploiting a health or safety issue by hiking prices. The framework is currently open to public comment for 60 days before any final decisions are made.

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Response from the Pharmaceutical Industry

Pharmaceutical companies have historically argued against the use of march-in rights, asserting that it would disincentivize the development of new drugs. In response to the newly published framework, the main pharma industry trade group, the Pharmaceutical Research and Manufacturers of America, criticised the guidance, indicating potential pushback from the industry.

A Controversial Move Amid Soaring Drug Prices

The issue of high-priced, taxpayer-funded drugs has been a hot topic in recent years, especially in light of the cost of COVID-19 vaccines. This move by the Biden administration opens the door for potential policy changes in the future, offering an alternative solution to address drug affordability. However, the controversial nature of this policy and its potential impacts on the pharmaceutical industry’s innovation and drug development remain to be seen.

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