- Endo Pharmaceuticals will pay the state of New York $200,000 to settle charges that the company knowingly downplayed risk of addiction with its Opana ER opioid painkiller, Stat News reported.
- In addition, the firm must stop misrepresenting the drug’s abuse-resistant properties and overhaul its marketing practices for Opana ER.
- New York Attorney General Eric Schneiderman said Endo “improperly” marketed Opana ER as crush-resistant when its own studies showed the drug could be crushed and ground.
Endo’s misrepresentation of the tablet’s crush-resistant properties probably increased sales, but “provided a false sense of security” to doctors and patients, Schneiderman said in a statement.
The investigation also found that Endo instructed its sales people to minimize the risks of using Opana ER and that the firm had “no meaningful program” to discourage its diversion by healthcare providers.
“Numerous New York health care providers who were heavily ‘detailed’ by Endo were subsequently convicted of illegal prescribing of prescription opioids,” Schneiderman said.
Every day in the U.S., 44 people die from overdosing on prescription pain drugs, according to the CDC.
The problem has sparked efforts on Capitol Hill to address the epidemic, and prompted the FDA to rethink how opioids are labeled, approved, and monitored once on the market.
In addition to the $200,000 fine, Endo agreed to create an abuse and diversion deterrent program, post clinical trial results on the company website, push doctors to educate themselves about best opioid prescribing practices, and provide providers with resources that help patients understand the risks of addiction.