Friday, May 22, 2026

November will bring political change. Will it also change drug prices and PDUFA?


In five months, midterm elections will determine the composition of Congress, which could reinstate or veto legislation to lower drug prices. Political strategists expect Republicans to control the House of Representatives. Dan Todd, founder of Todd Strategy Group, said this year’s vote was a “change election” that typically doesn’t support those in power. But the change in power will not remove the pressure to take action on drug prices.

“It’s going to be a good day for Republicans on Election Day and a bad day when they realize what they have to do,” Todd said.

Todd, whose company represents companies across the healthcare industry, spoke at a conference panel discussion at the Biotechnology Innovation Organization (BIO) annual meeting in San Diego on Wednesday. Vin Roberti, chairman and co-founder of Roberti Global, joined Todd’s group. Roberti expects Democrats to lose 20 to 25 House seats. Todd estimates there are about 20 seats, adding that the bodywork “will be more ‘Trump’ than it looks now, which is more challenging for our industry.”

The main drug price legislation likely to be faced by current and incoming lawmakers is the sweeping “build back better” bill. “Building back better,” as written and passed in the House last year, is overkill, Roberti said. More and more elements are being added to the legislation, broadening the scope and making it less likely to pass the Senate. The bill was originally supposed to be about infrastructure, but it gradually covers other areas, such as capping insulin prices and enabling the federal government to negotiate the price of some high-cost drugs covered by Medicare Parts B and D.

Medicare Part D covers prescription drugs. But Todd said out-of-pocket costs, such as co-pays and high deductibles, meant it didn’t work for many patients. Nonetheless, political messages are part D valid and should be left as-is. Patient groups recognize these out-of-pocket costs need to be addressed, but the question remains whether Democrats and Republicans will find enough of a middle ground to address it. “I think it’s going to spark a lot of discussion,” Todd said. “I don’t think Republicans can ignore that right now.”

BIO’s policy stance Legislation should always focus on patient out-of-pocket costs, and laws that limit or control drug prices have the unintended consequence of undermining innovative research that brings new medicines to patients.

If Republicans control Congress to block drug price legislation, another option would be presidential action, such as an executive order, Roberti said. President Biden could also create a program on drug pricing. Roberti added that while politicians talk about drug pricing, they don’t understand the consequences, such as the impact on research and development. But Roberti also singled out the biopharmaceutical industry, saying the industry is not doing a good job of bringing its people to Capitol Hill for advocacy. If lawmakers hear that people in their area are creating drug innovations, that might persuade them to take a different stance.

Other challenges facing the biopharma industry include the rise of populism and a lack of understanding of how the system works, Roberti said. As an example, he cites the Prescription Drug User Fee Act (PDUFA), which regulates what biopharmaceutical companies pay to fund the drug review process. The law will be reauthorized this year, but Roberti questions how many MPs even know what a PDUFA is. Lawmakers’ experience matters, and that experience is being lost. A few years from now, Roberty said, there will be more lawmakers in Congress driven by something other than knowledge.

“That’s my concern for your industry,” he said.

Photo: MikeyLPT, Getty Images



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