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

In five months, midterm elections will determine the composition of a Congress that could reinvigorate or reject legislation aimed at lowering drug prices. Political strategists predict that Republicans will take control of the House of Representatives. This year’s vote is an “election for change,” and such elections typically don’t go in favor of those in power, said Dan Todd, founder of the Todd Strategy Group. But the power shift won’t remove the pressure to do something about drug prices.

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

Todd, whose firm represents healthcare companies, spoke during a panel discussion Wednesday at the Biotechnology Innovation Organization (BIO) annual meeting in San Diego. Vin Roberti, president and co-founder of Roberti Global, joined Todd on the panel. Roberti predicted that Democrats could lose 20 to 25 seats in the House. Todd put his estimate at around 20 seats, adding that the body composition “will look more ‘Trumpy’ than it does now, which for our industry is more difficult.”

The main drug pricing legislation that current and future lawmakers may face is the sweeping “Build Back Better” bill. As written and passed in the House of Representatives last year, Build Back Better went too far, Roberti said. More and more material was added to the legislation, an expanded scope that made it less likely to pass the Senate. The bill was supposed to be about infrastructure, but it has grown to encompass other areas, with provisions like capping insulin prices and giving the federal government the ability to negotiate prices for some expensive drugs. covered by Medicare Part B and Part D.

Medicare Part D covers prescription drugs. But out-of-pocket costs, such as copayments and high deductibles, mean it doesn’t work for many patients, Todd said. Nevertheless, the political message is that Part D works and should be left as is. Patient groups realize that these out-of-pocket costs need to be considered, but the question remains whether Democrats and Republicans will find enough common ground to resolve it. “I think it will spark a lot of discussion,” Todd said. “I don’t think that’s something Republicans can ignore at this point.”

BIO’s policy position has been that legislation should focus on patient spending and that laws capping or controlling drug prices would have the unintended consequence of disrupting innovative research that brings new drugs to patients.

If Republican control of Congress blocks drug pricing legislation, an alternative is presidential action, such as executive orders, Roberti said. President Biden could also mount a project on drug pricing. Roberti added that while politicians talk about drug prices, they don’t understand the ramifications, such as the impact on research and development. But Roberti also called out the biopharmaceutical industry, saying the sector isn’t doing a good job of getting its people to Capitol Hill to advocate. If lawmakers heard of people in their own districts creating drug innovations, that might persuade them to take a different stance.

Other challenges for the biopharmaceutical industry include rising populism and a lack of understanding of how the system works, Roberti said. As an example, he cited the Prescription Drug User Fee Act (PDUFA), the law that sets the fees paid by biopharmaceutical companies to fund the drug review process. The law is slated for reauthorization this year, but Roberti wondered how many members of Congress even know what PDUFA is. The experience of legislators counts, and that experience is lost. Roberti said that in a few years there will be more lawmakers in Congress motivated by more than knowledge.

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

Photo: MikeyLPT, Getty Images

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