In the midst of a national opioid crisis, the federal agency that monitors drug ads has issued a record low number of warning letters to pharmaceutical companies caught lying about their products.
The Food and Drug Administration has sent a mere three letters to drugmakers busted for overhyping their medications to unknowing consumers, the lowest ever since the agency’s historic decision to ease strict rules for ads in 1997.
“It certainly raises questions,” said Dr. David Kessler, who helmed the FDA from late 1990 through 1996.
The FDA’s Office of Prescription Drug Promotion monitors all ads drug companies issue to make sure patients aren’t being scammed by false assertions.
The pharmaceutical industry spent a vast $6.4 billion in “direct-to-consumer” advertisements to hype new drugs in 2016, according tracking firm Kantar Media. That figure has gone up by 62% since 2012, Kantar Media says.
But the agency has long struggled to keep track of the thousands of ads published each year, largely due to lack of staff.
There are approximately 60 FDA staffers responsible for keeping track of at least 75,000 ads and other promotional material published each year.
“It’s a very, very small unit,” a former high-ranking FDA official said. “It’s historically been underfunded.”
Additionally, many of the ads are submitted to the FDA for review at the same time they begin to run. So by the time the assessment is complete the ad has “already had a significant impact,” the FDA insider said.
Critics say the FDA needs to do more to stay on top of an industry with a history of trying to maximize profits by at times misleading consumers.
The number of public admonishment letters has been at or close to single digits from 2014 until 2016 during the Obama administration, records show.
The FDA sent out 11 of those caution missives in 2016, nine in 2015 and 2014, and 24 in 2013.
This year, one of the warning letters was sent to Canadian drugmaker Cipher Pharmaceuticals, ordering it stop using deceptive promotional material to hawk its extended-release opioid ConZip.
The ad failed to note “any risk information” highlighting the potentially addictive nature of the powerful painkiller, the FDA letter issued Aug. 24 said. The promotional material was also misleading because it asserted other treatment options “are inadequate,” the oversight agency concluded.
“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.
The agency demanded that Cipher “immediately cease misbranding” the medication. The drug company responded by yanking the promotional material, the firm’s execs said in a statement issued after the warning letter was made public.
But that was the single caution letter issued to an overhyped painkiller by the FDA this year so far, records show.
The other caution letters were sent to Amherst Pharmaceuticals for the insomnia drug Zolpimist, and to Orexigen Therapeutics Inc. for its weight loss drug Contrave.
The FDA maintains that letters to drug companies are merely one tool the agency uses to keep the pharmaceutical industry in line.
“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 said. “The FDA’s priorities regarding prescription drug promotion are policy and guidance development, labeling reviews, core launch and TV ad reviews, training and communications and enforcement.”
