December 21, 2015

FDA Group’s Larry Stevens Finds Major Issues With Sen. Cruz’s FDA Overhaul Proposal

Earlier this month, Republican presidential candidate Sen. Ted Cruz (TX) and Sen. Mike Lee (R-Utah) introduced a new bill seeking to overhaul FDA operations and make it easier to introduce drugs and devices into the marketplace.

The “Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act” (or RESULT Act) would make three major changes:

  1. Reciprocal approval of drugs, devices and biologics from foreign sponsors in EU member countries as well as Israel, Australia, Canada and Japan.
  1. A requirement on FDA to decide on life-saving drug and device applications within 30 days.
  1. A provision allowing Congress to override FDA denials for certain applications of life-saving drugs with a majority vote through joint resolution.

While Sen. Cruz says the proposed changes will “unleash life-saving drugs and devices in the United States,” former FDA official and FDA Group consultant Larry Stevens revealed some major shortcomings of the ideas in a recent article published by the Regulatory Affairs Professionals Society.

Two problems posed by the RESULT Act

According to Stevens, while the changes sound good on the surface, they ignore some major issues when looked at from a practical perspective.

1. The FDA will simply reject applications approved by countries with less stringent standards

To Stevens, the problem with the reciprocal approval of drugs from other countries is simple:

“No developed country has the expertise to review a product like the FDA does.”

If the bill became law, companies would simply seek approval from countries with the lowest standards and then wait on word from the FDA. Even with 30 days to act, however, Stevens is confident the FDA would still reject nearly every application, leaving companies in the same place they started.

Stevens offered Thalidomide as a real-world example of the problem. While the drug was approved in Europe, it would later be shown to lead to birth defects, an outcome the FDA prevented in the U.S. by denying the application despite European approval.

2. Congressional override would undermine scientific scrutiny

With the ability to override an FDA denial in Congress, Stevens warns we’d be relying on emotion rather than scientific evidence to decide which drugs enter the market.

“FDA gets rid of the emotion,” he said, adding if Congress did override an FDA decision, it would leave congressmen responsible for the drug or device’s safety.

Although the bill is highly unlikely to receive President Obama’s signature, the proposal may breathe new life into the conversation around FDA reform which started with 21st Century Cures Act.

Want to learn more about the FDA’s current expedited approval programs? Grab our free whitepaper: New Drug Applications: What You Should Know.

Topics: Regulations, In the News, FDA regulatory consultants, Global Regulations