FDA issued the fewest warnings over pharma advertising this year since 1997
Throughout 2017, it has emerged that the FDA has issued a record low number of warning letters to pharmaceutical firms over misrepresentation of their products – a total of just three, the lowest since 1997, when the agency made the decision to relax its strict rules for the advertisement of pharmaceutical products.
The division of the agency responsible for monitors these advertisements has often been accused of understaffing and underfunding, with just 60 FDA employees responsible for keeping track of at least 75,000 ads each year. Compounding the issue is the fact that most of these ads begin running the same time they are given to the FDA for inspection, meaning that they have often had a considerable impact on consumers before they can be regulated.
In recent years, the agency has managed to bring down the number of warning letters issued, with nine in 2015 and 2014, compared to 24 in 2013. This year’s performance significantly undercuts the number of warnings issued in 2016, when the agency sent out a total of 11.
The three warnings this year were sent to Amherst Pharmaceuticals for its insomnia drug Zolpimist, Orexigen Therapeutics for its weight loss drug Contrave, and Cipher Pharmaceuticals for its extended-release opioid ConZip.
The FDA warned Cipher that its advertisement did not include “any risk information” advising over the potentially addictive nature of the painkiller, while also asserting that other treatment options “are inadequate.”
“By omitting […] serious and potentially fatal risks, the detail aid […] creates a misleading impression about the drug’s safety, a concern heightened by the serious public health impacts of opioid addiction, abuse and misuse,” the FDA said in its warning letter.
After the FDA demanded that Cipher “immediately cease misbranding” the drug, the Canadian firm pulled its the promotional material.
“We have many efforts to encourage compliance by industry, including our work on guidances, providing advice to companies on draft promotional materials, and outreach to our stakeholders,” FDA spokeswoman Stephanie Caccomo explained. “The FDA’s priorities regarding prescription drug promotion are policy and guidance development, labelling reviews, core launch and TV ad reviews, training and communications and enforcement.”
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