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What pharma executives might expect from the FDA and CMS under the Biden administration

The potential impact of agency priorities on R&D and drug pricing

With a new administration and a narrow Democratic majority in Congress, many of the most significant near-term actions for pharmaceutical companies will likely come from the FDA and CMS. Broader use of accelerated drug reviews, heightened expectations about diverse populations in trials, small drug pricing pilots and more could all be possible as new leadership takes the reins at the FDA and CMS. PwC’s Health Research Institute (HRI) interviewed health industry advisers and trade association executives to gain a clearer understanding of the potential agency policies and breaks down how it could affect the pharmaceutical and life sciences industry.

What are the FDA’s priorities?

The FDA has played a central role in the pandemic response, expediting the approval of myriad medical products including diagnostics, therapeutics and vaccines. While the crisis is likely to be a focus for the foreseeable future, the FDA is also likely to seek to standardize policies implemented in response to the pandemic.

FDA priorities to keep an eye on:

  • Accelerating the FDA’s review process
  • Addressing clinical trial diversity
  • Prioritizing visibility of the medical supply chain
  • Advancing the FDA’s agenda with digital therapeutics and the use of artificial intelligence
  • FDA regaining control over COVID-19 laboratory-developed tests and diagnostics

More than 380 emergency use authorizations (EUAs) have been granted

U.S. Food and Drug Administration Emergency Use Authorization information

How should pharmaceutical companies prepare for changes at the FDA?

Increasing diversity in clinical trials

Companies should plan for and build minority outreach and inclusion into their clinical trial strategies, moving beyond simply age-based benchmarks to racial and ethnic trial enrollment benchmarks.

Advanced supply chain analytics

Companies should continue to think more long term about how to improve their supply chain and understand the opportunity that could exist with strategies such as dual sourcing. Advanced supply chain analytics can drive transparency and communication while reducing costs associated with shortages. Analytics and cybersecurity are needed to integrate the supply chain and will likely require investment that could pay dividends, allowing manufacturers to avoid stockouts and shortages and deliver on the promise of the right treatment to the right patient at the right time in the right place.

Accelerated review timelines

In therapeutic and/or disease areas where the agency decides to adopt a more accelerated review process, companies may need to ensure that they are equipped to manage the different facets of drug review occurring simultaneously.

Q: If there was an opportunity to participate in a clinical trial to develop a treatment for COVID-19, how willing would you be to participate?

Hispanic, Latin or Spanish

Very willing
Somewhat willing
Somewhat Unwilling
Not willing

Source: PwC’s Health Research Institute September 2020 Consumer survey.
Chart excludes 1-3% within the groups who are current or past trial participants.

What are CMS' priorities?

Drug pricing is a key pillar of President Biden’s healthcare agenda as well as his predecessor’s, but past administrations have struggled to get anything done legislatively when Congress is so narrowly divided, increasing the likelihood that CMS could be the administration’s best chance to implement piecemeal actions.

CMS priorities to keep an eye on:

  • Addressing drug costs
  • Small pilots to test new methods to pay for Medicare Part B drugs

  • Addressing out-of-pocket costs for Part D drugs

  • Better coordination with the FDA to address reimbursement costs

  • New rules that could favor 340B hospitals

Healthcare costs have been climbing, with some annual increases hovering between 6.8% and 5.5% since 2014

HRI’s annual Medical Cost Trend

How should pharmaceutical companies prepare for changes at CMS and 340B?

Potential for upfront costs

Prepare for potential upfront costs associated with out of pocket savings programs, but this investment will likely provide long term revenue benefits through improved new patient starts, greater adherence over time, and overall uptake of medicines.

Minor shifts in revenue

For companies with a greater mix of Part B drugs, anticipate the potential for minor shifts in revenues from pilot programs. While the experiments will likely be small, they could result in a dampening of revenue growth in some categories. Companies should also begin to analyze and respond to the potential pilot programs.

Open discussions with payers

Prepare to have more open discussions with payers such as CMS in parallel with late-stage trial planning and integrate cross functional capabilities across commercial and R&D to facilitate those interactions.

Continuation of 340B drug sales

Expect 340B drug sales to continue to increase unless favorable legislation is passed in Congress that would narrow eligibility or place limits on contract pharmacies.

Generic approvals have increased but dispensing is flat, could CMS policies address this?

Contact us

Katherine Buckley

Partner, PwC US

Anup Kharode

Partner, Pharmaceutical & Life Sciences R&D, PwC US

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