The Canadian drug company Cipher Pharmaceuticals is in trouble with the Food and Drug Administration over its promotion of the opioid drug ConZip.
In August, the FDA’s Office of Prescription Drug Promotion issued a warning letter to Cipher for failing to include important information about the drug’s risks in promotional materials it sends out to doctors and other healthcare providers. The letter stated that by neglecting to include this information, the company’s marketing is “false and misleading” and creates a distorted impression about the drug’s safety and approved use.
An Egregious Omission
ConZip is a combination of both immediate- and extended-release of the opioid tramadol hydrochloride, which is used to manage severe pain on a daily, around-the-clock basis over a long period of time. The FDA noted that this omission is especially egregious given the opioid epidemic currently sweeping across the country, which has led to heightened scrutiny on drugmakers and their marketing campaigns.
The warning from the OPDP, which regulates how drug companies advertise their products, said that ConZip’s promotional materials, which taut the drug’s use for “All Day Pain Relief,” fail to mention any of the the drug’s risks, including its potential for abuse, its likelihood for addiction, and its potential to cause life-threatening respiratory depression.
Specifically, the letter states: “By omitting the risks associated with ConZip, including serious and potentially fatal risks, the detail aid fails to provide material information about the consequences that may result from the use of the drug and creates a misleading impression about the drug’s safety, a concern heightened by the serious public health impacts of opioid addiction, abuse and misuse.”
Moreover, the FDA said the misleading marketing materials also omit critical elements of ConZip’s indication, which specify that the drug should be reserved for patients who have already tried alternative treatment options, such as non-opioid analgesics or immediate-release opioids, and found those treatments ineffective.
Misleading Marketing Must Stop
The FDA demanded that Cipher, which licenses ConZip to Vertical Pharmaceuticals LLC for exclusive rights to sell the drug in the U.S., immediately stop distributing the misleading marketing materials, give the agency a list of all other materials that promote the drug in a similar fashion, and come up with a plan for issuing a corrective statement.
The letter requested that Cipher provide a written response to the warning by September 8, 2017, including a detailed plan of the company’s corrective actions. If Cipher fails to comply, the FDA said it would cease distribution of the drug in the U.S.
The warning letter is only the second one issued by OPDP in 2017. Compared to years past, the OPDP has been much less active in issuing such warnings to drugmakers.
Warning Letters on the Decline
This decline in warnings is a trend that started in 2010, when the agency sent 51 letters in a single year. Between 2012 and 2015, the regulator sent out a total of just 70 warnings, and last year, OPDP only issued 11.
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