By taking on “overly broad indications” on labels in a drug category that includes pain medications such as Purdue Pharma's Oxycontin and Endo Pharmaceutical's Percocet, a citizens' petition could regulate the way drugmakers market these products—and how CME programming about them is conducted.
The 37 signatories are asking the FDA to change the labels for prescription opioids to indicate that they are for severe pain, not for moderate-to-severe pain.
Dr. Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing, one of the signatories, told MM&M that walling off what could be considered off-label uses would help doctors to walk away from CME programming about the medications “with a better sense of the risks vs. the benefits.”
These moves could also have a direct impact on promotion. Two of the-top 25 advertisers in professional media in 2011 were marketers with opioids in their pain portfolios. Purdue, 12th on the list according to data from Kantar Media, spent $8.8 million for ads in journals last year, while Endo, 23rd on the list, spent $4.4 million. Not all of this money went to promote pain medications, but modifying the labels of these drugs will have an impact on the million-dollar conversations that surround them.
"Many physicians were taught that addiction was extremely rare,” Kolodny said, “and we've found this extremely false.”
Neither Purdue nor Endo were available for comment.