Roy reintroduces legislation to improve Americans’ access to lifesaving medicine by cutting FDA red tape
WASHINGTON — On Tuesday, Rep. Chip Roy (TX-21) reintroduced the “Reciprocity Ensures Streamlined Use of Lifesaving Treatments” (RESULT) Act to streamline the Food and Drug Administration’s approval process for potentially lifesaving medicines, thereby getting them to American patients sooner.
The RESULT Act would amend the Food, Drug and Cosmetic Act to allow for reciprocal approval of drugs approved in other trusted countries. This bill would require the FDA to quickly review drug, device, and biologic applications from companies that have products approved and sold in developed and trustworthy countries.
“The United States is often the first to approve drugs because the U.S. is considered the ‘gold standard’ in regulatory requirements and companies generally seek Food and Drug Administration (FDA) approval prior to the approval of the regulatory agencies in other countries. Unfortunately, however, that ‘gold standard’ has really proven itself to be a euphemism for ‘overzealous bureaucratic scrutiny’ and costs American lives each year due to unnecessary bureaucratic delays in the approval process. Indeed, we recently saw this situation unfold when the United Kingdom approved the Pfizer vaccine ahead of the United States.”
Congressman Roy reintroduced the legislation alongside his friend and fellow Texan, Sen. Ted Cruz, who introduced a companion bill in the Senate on the same day.
“I have long fought for the RESULT Act as much needed commonsense reform to our healthcare system. This bill removes burdensome red tape and expands access to crucial medical innovations already approved for use in other countries—providing greater access to medical devices, treatments, and drugs for all Americans. As we have witnessed in the coronavirus pandemic, when bureaucratic barriers are removed and private ingenuity is encouraged, historic vaccines can be produced in record time," said Sen. Cruz. "I urge my colleagues to pass this legislation and help continue to foster greater medical innovation as we overcome the challenges of this global pandemic.”
Congressman Roy first introduced the RESULT Act in March 2020 during the early weeks of the Coronavirus pandemic.
“The FDA should never stand in the way of getting lifesaving drugs and devices to the American people, but too often that is the case,” Congressman Roy added Tuesday. “The RESULT Act is a vital step toward fixing this problem.”
More specifically, the RESULT Act would:
- Amend the Food, Drug and Cosmetic Act to allow for reciprocal approval of drugs, devices and biologics from foreign sponsors in certain trusted, developed countries including the EU member countries, United Kingdom, Israel, Australia, Canada and Japan.
- Provide the FDA with a 30-day window to approve or deny a sponsor’s application for reciprocity.
- Instruct the Secretary of Health and Human Services (HHS) to approve a drug, device or biologic if the FDA confirms the product is:
- Lawfully approved for sale in one of the listed countries;
- Not a banned device by current FDA standards;
- There is a public health or unmet medical need for the product.
- Grants Congress the authority to disapprove a denied application and override an FDA decision with a majority vote via a joint resolution.