Opportunities in the Postmarketing Setting

... A 2009 article summarized the promotion of OxyContin (oxycodone) by Purdue Pharma between 1996 and 2001. Those efforts included hosting 40 all-expenses-paid speaker-training conferences for 5000 practitioners, as well as 20,000 pain “education” programs. Purdue used physician profiling to target high-volume opioid prescribers with sales representatives who were encouraged by a generous bonus system. Branded promotional items and free starter coupons for patients were available. The company also misrepresented the addiction risk posed by OxyContin in its materials for patients and physicians. The campaign paid off: annual sales increased from $48 million to $1.1 billion. Misleading statements about addiction risk amounted to misbranding, and they eventually cost the manufacturer and executives $634 million in fines. But evidence-based treatment for opioid addiction in patients whose addictions derived from treatment for chronic pain has been slow to emerge. And promotional efforts continue — even now, a manufacturer’s coupon for 80% off OxyContin is available online....

For controlled substances that pose a high risk of addiction and abuse, the FDA should have the power to limit or prohibit prescriber profiling and off-label promotion as well as the use of coupons or other forms of direct-to-consumer marketing. In light of the ongoing opioid epidemic, the rationale for permitting aggressive sales efforts is unclear. Although the FDA’s authority to regulate off-label marketing is the subject of several active court cases, opioids represent a special case, given the devastation and death they have caused. First Amendment arguments for reducing the amount of evidence required for marketing drugs for off-label uses do not rise above the compelling public health arguments favoring limitations on opioid marketing. If the FDA were to require new statements on opioid labels about the absence of evidence of long-term safety and efficacy in order to limit or prohibit companies from marketing those drugs for off-label uses such as long-term treatment of chronic noncancer pain, physicians’ prescribing options wouldn’t necessarily be limited. If it’s not clear that the FDA has the authority to limit the off-label marketing of controlled substances, Congress could expand the agency’s authority to modify what has been one of the main drivers of the opioid epidemic.
Most interventions available to the FDA to limit opioid prescribing and abuse are no match for the force of the culture that emerged from the confluence of interests of industry, influential academics, and pain societies during the 2000s. Now that opioid prescribing is widespread, system-level and not simply individual-level interventions will be required to change medical practice.

Beginning around 2010, our clinic made several changes to improve the risk–benefit profile for management of chronic pain. We adopted controlled-substances agreements, implemented urine testing and prescription-drug–monitoring programs, convened an opioid review committee to assist clinicians with difficult cases, started using pharmacists to help oversee opioid prescriptions at the clinic level, and provided education, support, and access to pain-management specialists. More recently, we fully integrated medication-assisted treatment for addiction into the primary care setting, providing a crucial evidence-based tool for treating high-risk patients.These system- and clinic-level activities have shifted the culture surrounding pain management in a way that could never have been accomplished by providing only continuing medical education about opioids to individual physicians. Reports describing the results of systemwide interventions at other facilities have come to similar conclusions. Reducing unnecessary exposure to opioids and improving physician education about pain management (not limited to opioid prescribing), as recommended in recent guidelines from the Centers for Disease Control and Prevention, represent additional and important primary prevention efforts.

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The FDA should mandate evidence and the regulation of marketing