15 June 2017

The FDA Group's Larry Stevens to Baltimore Sun: The Regulatory Path to Warning Labels for Acid Reflux Drugs

Acid Reflux Drug Warning LabelsThe Esophageal Cancer Action Network, a national nonprofit organization based in Baltimore, recently filed a citizen's petition with the U.S. Food and Drug Administration asking the agency to require warnings about the cancer risk of acid reflux on the labels of over-the-counter medications.

While labels on these over-the-counter medications currently warn people to get their doctors' recommendation before taking the medicine and warn against long-term use, they don't mention a cancer risk.

Speaking to The Baltimore Sun's Andrea K. McDaniels, experts agreed that patients are not being adequately informed of the risk of esophageal cancer associated with long-term use.

The FDA Group's Larry Stevens weighed in to explain the factors and process that could lead to new warning label requirements from regulators.

From The Baltimore Sun:

"The FDA doesn't get many citizens petitions, maybe a couple a year, said Larry Stevens, a former FDA official who works for the FDA Group, a consulting firm of former agency employees.
 
Stevens said the agency would want documentation that the lack of warning is a public health problem. If it decided a warning label was worth pursuing, the agency would hold a hearing on the issue.
 
At the very least, ECAN gets their issue in front of the agency, he said.
'It will spark the FDA to look at the issue for sure and that may be what [ECAN] is really after, trying to bring the problem to the forefront,' Stevens said."
 

Read the full story from The Baltimore Sun here.

 

Topics: In the News