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Washington Examiner: Ted Cruz bill would speed FDA approval of drugs OK'd in other countries

Reintroduces RESULT Act to expand medical innovation, lower healthcare costs

July 19, 2019

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WASHINGTON, D.C. - The Washington Examiner highlighted U.S. Sen. Ted Cruz's (R-Texas) reintroduction of the RESULT Act, which would amend the Food, Drug and Cosmetic Act to allow for reciprocal Food and Drug Administration (FDA) approval of drugs, devices, and other medical therapies already approved in other trusted countries, thereby increasing access to life-saving innovations for all Americans. The bill text may be viewed here.

"This is a commonsense reform that should garner bipartisan support from Congress," Sen. Cruz said. "The RESULT Act is a much needed reform of the FDA to expand access to medical innovations, mitigate critical drug shortages, and lower the cost of medical devices and drugs. I call on my colleagues to champion medical innovation and unleash a supply-side medical revolution for patients in the United States."

Read the article in its entirety here and below:

Ted Cruz bill would speed FDA approval of drugs OK'd in other countries
Washington Examiner
Kimberly Leonard
7/18/2019

Drugs and medical devices that have been authorized in other developed countries would face fast-track approval in the U.S. under a bill introduced Thursday by Ted Cruz.

The bill, the "RESULT Act," would give the Food and Drug Administration 30 days after a company sends in an application to decide whether it wants to greenlight a drug, device, or biologic approved in another country that adequately checks for safety and effectiveness. If FDA decides to reject the application, Congress would have the power to override the decision.

"If it's good enough for other countries, we should have access to those too," an aide to the Republican Texas senator said in an interview with the Washington Examiner.

Legislators from both parties have been working toward legislation to lower drug prices, including bills that would help drugs get to market faster. In a move somewhat related to what Cruz is proposing, the Trump administration has been working with states to help them find ways to import drugs from other countries. In those cases, however, the drugs have already been approved in the U.S.

Vermont's Bernie Sanders, an independent who caucuses with Democrats in the Senate, has led other Democrats to support drug importation, but Cruz hasn't been able to generate interest among Democrats for his bill, his aide said.

At this time, the only co-sponsors are other Republicans: Ron Johnson of Wisconsin and Mike Lee of Utah. The bill's full title is the Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act.

Public health advocates have raised safety concerns over drugs and medical devices that have been approved too quickly, because they're tested in a limited population. Drugs sometimes come with further warnings or even get pulled from the market after they have been tried by more people, showing side effects that weren't apparent during clinical trials.

Cruz's goal is not only to reduce the prices of drugs and devices by introducing more competition into the market, but also to improve access to life-saving medicines that people might not have in the U.S.

"The direction where this is coming from is trying to address drug access and prices from the bottom up," his aide said.

A significant amount of pharmaceutical companies first get approved in the U.S., so the legislation wouldn't apply to a massive number of drugs and medical devices, but it could move along a more limited number of products. The bill is primarily aimed at smaller companies, which have a harder time than larger manufacturers navigating and paying for the FDA approval process.

Companies that make the drugs would need to submit a request to the FDA showing that their product is allowed to be sold in another country that belongs to a specified list of countries. The companies would also have to show that the drugs or devices weren't withdrawn from the market because of safety concerns, and must show how their product would fill a public health or medical need.

The FDA would have the option of asking for more studies rather than approving the company's request after 30 days.

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