Joe Biden’s presidential inauguration this week could signal major changes for the pharmaceutical industry. Pharmaceutical companies contributed 294% more money to the Biden campaign compared to the amount they contributed to the Republicans and Trump. What that will mean for how the Biden administration approaches the industry will be interesting to watch. Here are five ways we believe a Biden presidency will impact medical affairs teams, and more broadly, the pharmaceutical industry, over the next four years. 

1. Drug Pricing Policy Could Change 

With Joe Biden inaugurated as the 46th president, and with slim majorities in both the House and Senate, the pharmaceutical industry could see policy changes on drug pricing although movement on drug pricing reform may be slow due to the makeup of Congress. One of Biden’s stated goals is to establish an independent review board under the Secretary of Health and Human Services (HHS) to assess new drugs’ value and pricing. This could lead to reference pricing based on other countries’ prices for the same drugs. This review board would also set the price for Medicare and other public-option insurance, which private payers often use as a benchmark for setting their own prices. 

Medical affairs teams, especially those with responsibility for health economics and outcomes research (HEOR) functions, will be more involved in gathering data and helping to collect patient reported outcomes and pharmacoeconomic research to support the prices their companies prefer. Pharma companies will become increasingly dependent on health outcomes liaisons to communicate their product’s value to payers, both public and private. Depending on what type of legislation passes around drug pricing reform, medical affairs may see a shift in strategy toward more HEOR-related activities. For smaller biotech and midsize companies, medical science liaisons (MSLs) may need to be more broadly skilled at HEOR if no separate HEOR team exists; MSLs may have to play a dual role. 

2. Payer Communication Will Change if Medicare Negotiation is Required

One of Biden’s stated goals is to repeal laws that prevent Medicare from negotiating lower drug prices with pharmaceutical manufacturers. There’s some speculation as to how far the new administration can take a repeal of the Medicare negotiation law. But if this change occurs, pharmaceutical companies could feel the effect. 

Medical affairs teams will be more involved in coordinating data and bringing insights back from the field. These insights will undoubtedly affect how drug companies position and price their products. Some companies may choose to launch products in other markets prior to the US to affect the price they negotiate with Medicare. This will shift the regulatory and field medical teams’ focus to support launches in other countries.  Medical affairs will continue to become increasingly dependent on digital tools and technologies that provide these insights, such as predictive analytics to help prepare them for emerging competitive entrants. 

3. Changes to Patient Data Sharing Will Lead to Better Outcomes and Advances in Research

In 2018, Joe Biden penned an article for Fortune Magazine in which he stated his case for more patient control over their electronic medical health records. Biden supported the creation of pilot groups to allow patients to opt in to contributing their medical records for research. As part of Biden’s “Cancer Moonshot” initiative, he argued that comprehensive patient data should be shared through a new cancer data trust to make significant advances in research. 

Beyond cancer, Biden wants to extend this pilot approach to other therapeutic areas. In the Fortune article, Biden targets better patient outcomes through the application of Big Data. With more medical affairs teams investing in patient centricity, a change in the way that patient data is shared and accessed puts patients squarely in the middle of the conversation with a much greater voice. 

4. COVID-19 Response Could Invigorate More Investment in Vaccines

According to PricewaterhouseCooper’s research, Biden’s pandemic plans were largely viewed as positive. During the campaign, Biden committed himself to ramp up large-scale manufacturing of all coronavirus vaccines. Furthermore, he supports a national vaccination program to make sure that anyone who wants a vaccine can get one. 

Biden has pledged to vaccinate 100 million people in 100 days. With this increased focus on vaccines, there could be a significant push for pharmaceutical companies to make vaccine research and development a key area of focus. This effort would be positioned as preparation for future pandemics similar to COVID-19. Furthermore, the US will rejoin the World Health Organization and the Global Vaccine Initiative, which could lead to the US sharing more health technology with the rest of the world. 

5. The Need for Medical Affairs Will Continue to Grow. 

Cost pressure and risk mitigation means that Pharma needs a strong scientific voice at the healthcare decision-making table. Marketing and lobbying will likely be blunted in an environment where cost-cutting is seen as more critical than innovation. Medical Affairs can build a bridge between those two positions by demonstrating the power of better long-term health outcomes over short-term cost-cutting measures. Under the Biden administration, expect to see scientific expertise take a leading role again in decision making.

Regulators at FDA, such as acting FDA Principal Deputy Janet Woodcock, are likely to reassert their independent role separate from the politics of the Department of Health and Human Services. The government will need scientific expertise from pharmaceutical companies to guide their decisions. And medical affairs is ideally positioned to provide that  expertise within the industry. This could lead to a greater dependence on independent accreditation for MSL and medical affairs professionals.  As we look ahead to a new U.S. President, regardless of where you sit on the political aisle, it will be an important next four years for the pharmaceutical industry.

Read about our top five 2021 predictions for pharma