Record Low Number of FDA Warning Letters Sent to Drugmakers
Here’s a challenge for our readers: Spend one hour watching prime-time television on the network of your choice. How many drug commercials did you see? Drug manufacturers are increasing their advertising presence at what seems like a breakneck pace. And with serious public health crises like the opioid epidemic making daily headlines, one would expect that regulatory agencies would be doing everything they can to combat misleading ads targeted at the public. At the very least, FDA warning letters for deceptive or misleading ads should be a priority
However, a new report shows that very little is actually being done.
The Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion, which is tasked with monitoring all drug advertisements, only issued three warning letters in 2017:
- Orexigen Therapeutics received the first warning letter in May, over failing to include important risk information in advertisements for the company’s weight-loss drug Contrave.
- The second warning letter was issued to Cipher Pharmaceuticals in August, after its ad for the extended-release opioid ConZip omitted important risk information and other material facts.
- The last warning letter was sent in November to Amherst Pharmaceuticals, relating to a webpage for the anti-insomnia medication Zolpimist failing to communicate any risk information.
In its reporting on the story, the New York Daily News spoke with a former FDA official, who explained that a lack of resources was the likely cause of so few warnings being issued.
“It’s a very, very small unit,” a former high-ranking FDA official said. “It’s historically been underfunded.”
According to their source, the Office of Prescription Drug Promotion consists of approximately 60 FDA staff members. These 60 individuals are responsible for reviewing at least 75,000 ads and promotional materials published each year.
To make matters worse, drug ads don’t require FDA approval prior to launch. This means that many of the ads are submitted to the FDA for review at the same time they begin being seen by consumers. By the time the FDA has had a chance to review the ads and issue a warning, they could have influenced countless consumers.
It’s worth noting that a low number of warning letters issued by the FDA isn’t a brand-new occurrence. Only 11 FDA warning letters were issued in 2016, while 2014 – 2015 each saw only 9 letters sent to drug manufacturers. 24 warning issued in 2013.
Wexler Wallace is currently involved in litigation against pharmaceutical manufacturers in relation to their marketing of prescription opioids. To learn more about the case, click here.