Sens. Marshall, Smith, Cassidy Join Forces to Harness Real-World Evidence in FDA Approval Process

(Washington, D.C., May 3, 2021) – U.S. Senators Roger Marshall, M.D. (R-KS), Tina Smith (D-MN), and Bill Cassidy, M.D. (R-LA) introduced bipartisan legislation to harness real-world evidence (RWE) gathered during emergency use authorization (EUA) to support future approvals for drugs, biologics, and medical devices at the U.S. Food and Drug Administration (FDA). This legislation would enable the FDA to develop a clear framework for how it uses RWE in premarket approvals ranging from drugs and vaccines to medical devices. Not only will this help with clinical decision-making and making practical adjustments during a pandemic, this legislation could also help in shortening the length of time it takes for the FDA to approve a product and could help in reducing the cost for medical innovators to bring a product to market. The bipartisan collaboration comes on the heels of President Joe Biden recently signing into law their bill to help lower prescription drug prices.

“Our nation has experienced a historical response in the development of therapeutics and vaccinations to combat COVID-19. However, it is important that the data generated from patients utilizing these therapeutics and vaccinations are considered during FDA’s final approval process for future drugs, biologics, and medical devices – our bipartisan legislation does just that,” said Senator Marshall.

“As we continue to respond to the pandemic—and prepare for the future—we should be actively working to streamline the FDA approval process for products deemed as critical during public health emergencies,” said Senator Smith. “For example, right now there are other COVID-19 vaccines that have been authorized under the FDA’s Emergency Use Authorization. However, they are not fully approved by the FDA. This bill would allow for the real-time evidence we are collecting on the safety and effectiveness of authorized products, like COVID-19 vaccines, to be used for their formal approval. This will ultimately help us respond to public health emergencies more efficiently.”

“The FDA should be able to do what doctors do, take all the evidence that there is and make the best decision for their patient,” said Dr. Cassidy.


Real-world evidence (RWE) is rapidly expanding across all sectors in health care – especially in drug and medical device development. Congress recognized the value of RWE and passed the bipartisan 21st Century Cures Act to help accelerate new innovative treatments by requiring the FDA to evaluate the use of RWE to help support the approval of a new indication for a previously approved drug and to help support or satisfy post-approval study requirements. As a result, the FDA developed a framework for the RWE Program. RWE for EUA and premarket approval, however, does not have a clear framework. Under current law, the FDA evaluates it on a case-by-case basis.

Example of COVID RWE:

Earlier this year, Senator Marshall penned an op-ed in the Wall Street Journal highlighting the RWE showing that giving more people a single dose of the COVID-19 vaccine saves more lives than giving fewer people two doses right away. Specifically, Senator Marshall highlighted robust RWE finding that the effectiveness of one shot of the Pfizer or Moderna vaccine ranges between 72 percent to 92.6 percent after two weeks. These studies have also found the second shot could be given 12 weeks later instead of three or four weeks and be equally effective. Recently, the New York Times highlighted Britain’s vaccine success and reaffirmed Senator Marshall’s WSJ opinion about RWE saying that we could save tens of thousands of lives if we follow the science and give one shot of the COVID vaccine to as many people as possible and came back for a second dose as more vaccines are available.