Republican presidential candidate Sen. Ted Cruz (TX) and Sen. Mike Lee (R-Utah) on Friday introduced a bill that would completely overhaul the way the US Food and Drug Administration (FDA) operates.
More specifically, the “Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act (S. 2388), or the RESULT Act,” would:
- allow for reciprocal approval of drugs, devices and biologics from foreign sponsors in EU member countries, Israel, Australia, Canada and Japan
- require FDA to make a decision on “life-saving” drug and device applications within 30 days
- allow Congress to override FDA denials of certain applications for life-saving drugs with a majority vote via a joint resolution
“Our legislation will unleash life-saving drugs and devices in the United States, help mitigate critical drug shortages in the US, and put downward pressure on the prices of medical devices and drugs as well,” Cruz said in a statement.
Larry Stevens, retired FDA official and consultant with the Massachusetts-based FDA Group, told Focus that conceptually the bill “sounds good” but the reciprocity idea will not hold up because “no developed country has the expertise to review a product like the FDA does.”
If the bill were approved, companies would gain approval for their drugs or devices from countries with the lowest standards, then go to FDA for approval, but Stevens predicted that FDA would reject 99.9% of those applications even with only a 30-day window. He also explained that relying on Congress to override FDA decisions would mean relying on emotional rather than scientific evidence.
“FDA gets rid of the emotion,” he said, adding that if Congress did override an FDA decision, congressmen would technically be responsible for the drug or device’s safety.
He also offered the classic example of thalidomide, which was approved in Europe, but held up by FDA in its review, and later led to a number of birth defects in Europe that did not occur in the US because it failed to pass muster with FDA.
And Cruz’s claims that FDA’s risk-averse nature is creating an environment in which the agency isn’t approving enough new drugs seems to run counter to the 42 new drug approvals (and counting) this year, which is a 19-year high. Critics of the bill also point to the fact that such reciprocal approvals would significantly diminish the role of FDA.
Dr. Walid Gellad, co-director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh, told Focus: “The bill essentially removes FDA from the picture for drugs approved in another country, and gives its (FDA's) authority to determine if something is safe and effective instead to the secretary. And the piece about Congress over-ruling the FDA makes no sense from a public health, science, policy, or common sense point of view.”
And although the bill is unlikely to become law with President Barack Obama in office, it could restart a conversation, particularly in the Republican presidential race, around FDA reforms that began with the House-passed 21st Century Cures Act.
“Beyond reforming reciprocity, we need to modernize the FDA’s approach, expand the Accelerating Medicines Partnership (AMP), and embrace a culture of innovation, as foundations like XPrize are doing,” Cruz added in an op-ed last month.
FDA told Focus it does not comment on pending legislation.