# Securing America's Medicine Cabinet Act of 2021

This bill is designed to help the United States make and distribute medicines more efficiently and reliably. It does this by creating two main programs: one that speeds up approval for new drug-making technologies, and another that establishes special centers at universities to research and teach advanced pharmaceutical manufacturing.

The first part creates a fast-track system at the FDA for drug manufacturers who develop new ways to make medicines. If a company invents a manufacturing method that could prevent drug shortages, help during emergencies, or represent a genuinely innovative approach to making drugs, they can get it designated as an "advanced manufacturing technology." Once approved, this designation means the FDA will work closely with the company to move things along faster—holding regular meetings, providing advice, and having experienced FDA staff collaborate on reviewing the new method. The big benefit is that once a company proves their new manufacturing technology works in one situation, they can use it for other products without having to submit all the same data over again, saving time and money.

The second part funds the creation of "National Centers of Excellence in Advanced Pharmaceutical Manufacturing" at universities across the country. These centers would be research hubs where scientists develop better ways to make drugs, train the next generation of pharmaceutical workers, and help the government respond to drug shortages or national emergencies. Universities that want to become these centers need to show they have the labs and expertise to do this work, a track record of turning research into real products, and the ability to work with drug manufacturers and other institutions. The bill authorizes $100 million in funding for these centers from 2022 through 2025.

Overall, this bill aims to make America less dependent on other countries for medicines and better prepared to handle situations where certain drugs become scarce or unavailable.

Securing America’s Medicine Cabinet Act of 2021

Buchanan, Vern

Securing America's Medicine Cabinet Act of 2021 This bill encourages the development and approval of advanced pharmaceutical manufacturing technologies and designates certain university research centers to assist in developing such technologies. The Food and Drug Administration (FDA) must continue to evaluate and approve new drug manufacturing technologies included in an application for drug approval and expedite the development and implementation of such technologies. The FDA must designate such a technology as an advanced manufacturing technology if it is likely to (1) prevent or resolve a drug shortage, (2) maintain an adequate supply of critical medications for national emergencies, or (3) promote the adoption of innovative approaches to drug design and manufacturing. The sponsor of such a designated technology must provide the FDA with certain related scientific evidence. After receiving this evidence, if the FDA validates the technology for a proposed use, then the sponsor may use the validated technology across multiple manufacturing product lines within the same use context without obtaining additional FDA validation. The FDA must designate certain institutions of higher education as National Centers of Excellence in Advanced Pharmaceutical Manufacturing. Among other requirements, such centers must demonstrate the ability to provide federal agencies with technical assistance and to train a future workforce in such technologies.