WASHINGTON—Today, Senator Mike Braun offered four healthcare amendments to the PREVENT Pandemics Act during an executive session of the Senate Health, Labor, Education and Pensions (HELP) Committee. The amendments offered by Sen. Braun would create opportunities for Americans to get faster access to drugs approved by other countries with similar regulatory regimes, demand transparency on the origins of the COVID-19 pandemic, curb reliance on Chinese pharmaceuticals, and prevent mandates on toddlers.

We cannot prevent future pandemics or address this current pandemic without knowing how the COVID-19 pandemic originated, curbing our reliance on the Chinese Communist Party for our pharmaceuticals, eliminating unscientific mandates like mask requirements for toddlers, and accelerating our drug approval process – I offered four these four solutions today in the HELP committee.”— Senator Mike Braun

Four of Senator Braun’s legislative priorities that were included in the PREVENT Pandemics Act include:

The Emergency Use Transparency Act which aims to increase the transparency around the vaccine approval process

The Protecting Patients from Counterfeit Medical Devices Act which cracks down on counterfeit medical devices in the domestic supply chain

The Promoting Access to Critical Countermeasures by Ensuring Specimen Samples (ACCESS) to Diagnostics Act which would support quicker research and development of medical countermeasures

The Apply the Science 2.0 Act which requires the National Academies of Sciences to conduct a study to better understand the value of natural immunity from COVID-19

BACKGROUND

The following amendments were offered by Senator Braun today:

Braun Amendment #1: This amendment would allow manufacturers of prescription drugs that are developed and marketed in foreign countries, but not yet approved in the United States, to submit an application to FDA for expedited review to market their drug in the U.S. Eligible countries would be limited to those with regulatory agencies that have evaluation regimes comparable to the FDA, and foreign drug manufacturers would be allowed to submit their applications with evidence collected from clinical trials conducted abroad. This amendment is substantially similar to the ADAPT 2.0 Act.

Braun Amendment #2: This amendment requires the Secretary of Health and Human Services to make public any and all information related to links between the Wuhan Institute of Virology and the origin of COVID-19, coordination conducted by HHS with entities in China performing research on coronaviruses, and research or literature review produced by HHS about the potential origin of COVID-19. This amendment is similar to the COVID-19 Origin Act of 2019.

Braun Amendment #7: This amendment would require FDA to create a registry of all drugs and corresponding APIs that are produced outside the United States and are determined to be critical to the health and safety of Americans. It would also require that HHS, Veterans Affairs, the Department of Defense, and all other federally qualified health facilities purchase pharmaceutical products for which 60 percent API come from countries that meet FDA’s health and safety standards (and do not come from China) by 2024, and that 100 of API for these drugs come from countries that meet FDA’s health and safety standards (and do not come from China) by 2026. Last, it would require drug companies to list the APIs and their countries of origin on the labels of imported and domestically produced finished drug products. This amendment is substantially similar to the ABC Safe Drug Act.

Braun Amendment #8: This amendment prohibits federal funds from being used to implement or enforce HHS’s rule, “Vaccine and Mask Requirements to Mitigate the Spread of COVID-19 in Head Start Programs,” or any substantially similar rule, regulation, or agency statement. The rule requires toddlers to wear masks while they are outside on the playground, and it mandates staff and volunteers to be vaccinated. This amendment is substantially similar to the Preventing Mandates on Toddlers Act.

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Issues