Scott, Carter Urge FDA to Follow Congressional Intent, Strengthen American Health Innovation

WASHINGTON — U.S. Senator Tim Scott (R-S.C.) and Congressman Earl L. “Buddy” Carter (R-Ga.-01) expressed concerns that the Food and Drug Administration (FDA) recently released draft guidance on advanced manufacturing technologies (AMTs) falls far short of adhering to Congress’s intent behind provisions of Senator Scott and Congressman Carter’s Manufacturing API, Drugs, and Excipients (MADE) in America Act. In a letter to FDA Commissioner Robert Califf, the lawmakers laid out three concerns regarding the FDA’s action to unnecessarily blur AMT’s definition and priorities, remove market incentives to develop AMTs, and reduce the streamlining and standardization that fuels innovation.

 “Section 3213 of FDORA established the Advanced Manufacturing Technologies Designation Program. This provision was based on the MADE in America Act and a recommendation the 2021 National Academies of Medicine report commissioned by FDA that recommended the agency review manufacturing technologies separately from individual product applications to facilitate greater adoption of modern drug production techniques. We are pleased that the FDA met the statutory deadline to release draft guidance on this new pathway. However, we are concerned that the draft falls short of the intent of, and contradicts, the statute.

The intent of this pathway was, in part, to help FDA meet its own stated goals of improving standardization and consistency among CGT manufacturing. If BLA holders are not able to cross reference information about AMT designated technologies, it removes a major incentive for application holders to utilize designated AMTs and for contract manufacturers to develop designated AMTs for use across the industry. We strongly suggest removing this limitation that is not driven by law.”

Read the letter in full here.

BACKGROUND

In 2020, Senator Scott introduced the MADE in America Act, alongside Congressmen Buddy Carter (R-Ga.-01), Tom Rice (R-S.C.-07),  and Darren Soto (D-Fla.-09). The bill sought to spur innovation and excellence in America’s healthcare system and strengthen the U.S. pharmaceutical supply chain. After reintroduction in 2021, portions of MADE were signed into law in 2022 as a part of the FY 2023 omnibus bill.   

One of MADE’s provisions required FDA to issue draft guidance on a new Advanced Manufacturing Technologies Designation Program, intending to build a pathway to advance novel manufacturing technologies, such as cell and gene therapies. FDA’s proposal disregards congressional intent, instead discouraging Americans  from developing innovative products.