The Food in addition to also Drug Administration has issued just three warning letters to drugmakers for misleading advertisements that will year — a record-low number, according to a fresh report.
The sharp drop-off in FDA warning letters for lies in addition to also misleading statements in ads in recent years, comes amid a 62percent increase in direct-to-consumer ad spending by pharmaceutical companies, according to the fresh York Daily News, which first reported the record low.
Drugmakers at that will point spend more than $6 billion annually on such ads.
In 2013, the FDA issued 24 warning letters to drugmakers, the Daily News reported. that will fell to nine in 2014, with that will same number again in 2015.
Last year, the drug regulatory agency sent out 11 letters.
yet until mid-November that will year, the FDA had sent out just two warning letters.
The first went out in May to Orexigen Therapuetics in connection having a TV ad for its weight-loss drug Contrave.
The FDA warned Orexigen that will the ad was misleading because the idea “fails to include important risk information associated with the drug,” such as listing multiple conditions for which Contrave will be contraindicated.
The second warning letter was sent in August to Cipher Pharmaceuticals for an ad for its extended-Discharge opioid ConZip. The FDA said the ad had omitted “important risk information associated with the use of ConZip in addition to also omits some other material facts.”
On Nov. 14, the FDA sent Amherst Pharmaceuticals a warning related to a webpage promoting the insomnia-treating medication Zolpimist.
“Both the webpage in addition to also the exhibit panels … fail to communicate any risk information,” the FDA said in its letter.
The agency went on to say the omission could create “create a misleading impression about the drug’s safety,” which will be “especially problematic through a public health perspective given the serious in addition to also potentially life-threatening risks associated with the drug.”
In its story about the record low number of warning letters, the Daily News quoted a former FDA official who said the agency’s Office of Prescription Drug Promotion — which monitors drug ads — will be “a very, very smaller unit” that will has “historically been underfunded.”
CNBC asked FDA about the report, in addition to also whether agency officials have been told to pull back on issuing warning letters that will year.
FDA spokeswoman Stephanie Caccomo, in an emailed statement, said “staff have not been instructed to avoid or reduce the number of enforcement letters issued to companies.”
Caccomo added, “Issuing warning letters will be just one component of the FDA’s multi-faceted program” for overseeing promotion of medical products.
She said the agency uses “a risk-based approach to carefully allocate its resources among these activities to contain the greatest beneficial public health impact.”
“Therefore, one cannot get a complete picture of the FDA’s program area by looking at a snapshot of time for warning letters,” Caccomo said. “Reviewing the number of warning letters that will the FDA issues on a particular topic within a year timeframe does not take into account the work that will the FDA does on the some other priorities to assist companies with compliance, such as policy in addition to also guidance development in addition to also core launch reviews, to fulfill its public health mission.”