Amneal and BioCorRx have earned the ire of the FDA’s Office of Prescription Drug Promotion (OPDP), with both being hit by accusations of violating the agency’s drug marketing rules.
The two pharmas received separate untitled letters from the U.S regulator detailing the offenses in late March, with both published on the FDA’s site on April 9.
The letter (PDF) to BioCorRx centers on the consumer webpage for the company’s Lucemyra (lofexidine), a non-opioid prescription medicine used in adults to help with the symptoms of opioid withdrawal.
The FDA said that the drug’s “webpage is false or misleading [and] misbrands Lucemyra.” The misbranding comes from the site’s assertion that Lucemyra is “the only FDA-approved, non-opioid medicine proven to help with symptoms of opioid withdrawal.”
The FDA points out that it has in fact green lit other lofexidine products in the same indication.
The regulator also took umbrage with the company’s decision to highlight 2020 guidance from the American Society of Addiction Medicine in large bolded font. The guidance states that lofexidine “should therefore be the preferred choice for withdrawal management in an outpatient setting, where monitoring of blood pressure and management of hypotension is more difficult.”
But the FDA points out that in contrast, the med’s full risk information is “only presented separately under the header, ‘Click to see full Important Safety Information & Prescribing Information,’ with lesser prominence.”
The OPDP noted in its letter that: “The overall effect of this presentation undermines the communication of important risk information and thereby misleadingly minimizes the risks associated with the use of Lucemyra.”
The other letter (PDF) was for Amneal and its drug Alymsys (bevacizumab-maly), a biosimilar to Roche’s oncology drug Avastin. Specifically, the OPDP said a direct-to-consumer patient brochure was “misleading” as it didn’t show Alymsys’s full FDA-approved indications.
“The presentations of the indications for Alymsys omit specific patient populations as well as its specific administration in combination with other chemotherapies,” the OPDP found.
The letter also details the brochure’s failure to “disclose material risk information regarding the serious risks associated with Alymsys,” which includes cause fetal harm when administered to pregnant women, as well as minimizing other risk factors.
This includes an assertion that all patients can expect that their side effects will resolve over time, “when this is not the case,” the FDA said.
Both companies were given 15 days on receipt of their letters to respond and come up with a plan to deal with the promotional violations.