An Example of How Even Small Pharmaceutical Companies Misrepresent the Safety of Opioid Painkillers to Healthcare Providers | Newtown News of Interest |

Collegium Pharmaceutical – a small pharmaceutical company located in Canton, MA (a small town of about 20,000 residents similar to Newtown, PA) – disclosed that it has received a letter from the FDA over misbranding pain med Xtampza ER (oxycodone) at a trade show in Minneapolis, MN last June.

Specifically, the agency said the company failed to adequately convey the risks of the drug in its exhibit booth at the American Society Health-System Pharmacists Summer Meetings & Exhibition 2017.

Here’s what the FDA said:

“OPDP [FDA’s Office of Pharmaceutical Drug Promotion, which oversees drug ads] notes that our advisory comments dated September 9, 2016, addressed draft Collegium presentations for Xtampza ER with certain similarities to the exhibit booth in this letter. In these advisory comments, OPDP recommended that Collegium revise proposed presentations so that they did not misrepresent the approved indication or omit important context; misrepresent or omit important risk information; or omit other material information. In particular, we cautioned Collegium about failing to present risk information for Xtampza ER with a prominence and readability reasonably comparable to the presentation of benefits. We are concerned that Collegium is promoting Xtampza ER in a manner that fails to adequately present the very serious risks of the drug, despite this direction from OPDP.

“The exhibit booth presentation made representations and/or suggestions about Xtampza ER but failed to adequately provide material information about the drug’s limitations of use and the serious and life-threatening consequences that may result from the use of the drug, thereby creating a misleading impression about the drug’s safety.”

Also read: “FDA to Determine if Oxymorphone, Produced by KVK Tech in Newtown, is More Likely to Be Abused Than Other Opioids”;