Senator Ted Cruz, R-Texas, has reintroduced a bill he thinks will speed US approval of drugs, biologics, or devices approved in other countries.
Senator Ted Cruz, R-Texas, reintroduced a bill he thinks will speed US approval of drugs, biologics, or devices approved in other countries.
The bill, called Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act, or the RESULTS Act, would give the Food and Drug Administration (FDA) 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.
It’s at least the third time Cruz has introduced the bill (the last 2 times were in 2015 and 2017), which would give Congress the power to override an FDA rejection of a product. The 2 other cosponsors are Senators Ron Johnson, R-Wisconsin, and Mike Lee, R-Utah.
Cruz has said the bill could put downward pressure on the prices of drugs and devices as well as alleviate drug shortages.
The bill orders the FDA to review drug and device applications within 30 days and allow “reciprocal approval” of therapies from the European Union, Israel, Australia, Canada, and Japan.
In previous years, health advocates and FDA observers have noted pitfalls with the idea. For one thing, the idea of giving a political body such as Congress the power to overrule the FDA’s scientific experts on matters relating to public health, safety, efficacy, science, and other concerns raises major concerns.
Cruz, like some other conservatives, say that US patients don’t have speedy access to possible life-saving treatments. In a previous press release about the RESULTS Act, he said it is time for a “supply-side medical revolution.”
Last year, conservatives saw one related victory with the passage of the so-called right-to-try law. The Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 creates an alternative pathway for dying patients who do not qualify for a clinical trial. The law bypasses the FDA's current expanded access and compassionate use programs and allows patients to appeal directly to drug companies.
That law, too, was based on the idea that the FDA does not move quickly enough.
The FDA approved 59 drugs in 2018, compared with 46 in 2017. Other studies have said that the FDA acts on applications more quickly than other regulatory authorities.