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Winners and Losers In Democrat’s Mega Social Spending Package

 
• By Sarah Karlin-Smith

Industry almost certain to avoid its worst pricing reform fears, but some post-exclusivity drugs may still be subject to negotiations under the most recent iteration of Build Back Better. Meanwhile, rare disease development incentives get cut and new funding is doled out for FDA.

Capitol_Water_Reflection
Drug negotiation provisions are so far absent from the current working version of the build back better legislation, a reflection of the power of pharma industry lobbying. • Source: Alamy

The framework for US President Biden’s Build Back Better Act, HR 5376, that went through the House Rules Committee on 28 October signifies a big win for the pharmaceutical industry as the draft drops Democrat’s attempt to allow the government to negotiate the cost of drugs. While there are ongoing discussions to try to get some drug pricing legislation back into the $1.75 trillion spending deal, this near-final version looks to be a more industry-friendly package.

From drug pricing to manufacturing to pandemic prep and US Food and Drug Administration modernization, the Pink Sheet went through the updated bill to provide readers

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Industry Leaders Grapple With Trump’s Most Favored Nation Pricing Plan

 
• By Jessica Merrill

At the Bank of America health care conference, pharma leaders speculated on the impact of Trump’s most favored nation pricing executive order on US and European markets.

Most Favored Nation Policy ‘Lazy, Misguided,’ But US Price Reforms Politically ‘Inevitable’

 
• By Cathy Kelly

Policy experts and pharma executives react to President Trump’s executive order on “equalizing” drug prices between the US and comparable nations at the ISPOR 2025 conference.

New Guidance Suggests SubQ Keytruda, Opdivo Formulations May Not Avoid Medicare Negotiations

 
• By Sarah Karlin-Smith

New draft guidance on the third cycle of Medicare drug price negotiations goes against Merck and BMS expectations for their cancer drugs. The guidance also tackles Part B and renegotiated prices for the first time.

House Budget Bill Includes Delayed Orphan Fix, Also Risks Downstream Cell and Gene Coverage

 
• By Sarah Karlin-Smith

The first two classes of negotiated drugs under the Inflation Reduction Act would not benefit from a rare disease adjustment House Republicans included in their reconciliation package.

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Industry On Making England’s HTA Innovation Lab A Success

 
• By Eliza Slawther

England’s health technology assessment institute, NICE, must ensure that there is clarity for manufacturers on how its methods and processes might change following testing in its sandbox environment, the Association of the British Pharmaceutical Industry said.

House Budget Bill Includes Delayed Orphan Fix, Also Risks Downstream Cell and Gene Coverage

 
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The first two classes of negotiated drugs under the Inflation Reduction Act would not benefit from a rare disease adjustment House Republicans included in their reconciliation package.

Trump’s Rx Pricing Order: The Best-Case And Worst-Case Scenarios

 
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US trade and tariff leverage might successfully push European and other countries to pay more for medicines, but if not, President Trump’s executive order includes potential US drug withdrawal and other options to entice industry to lower US prices.