Commentary: Opioid approvals should protect public health

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In this Jan. 18, 2013 file photo, Schedule 2 narcotics: Morphine Sulfate, OxyContin and Opana ER are displayed for a photograph in Carmichael, Calif.

Recent actions by federal and state officials have put opioid manufacturers in the spotlight at a time when drug overdoses are a national crisis. Efforts meant to fight abuse of prescription pain medication  may be helping company profit margins more than consumers and patients.

In July, the Food and Drug Administration (FDA) asked Endo Pharmaceuticals to pull its extended-release abuse-deterrent formulation (ADF) of oxymorphone, a potent opioid that goes by the brand name Opana ER, from the market. Within a few weeks, Endo agreed. This unprecedented action by the FDA came after an independent advisory committee voted that Endo’s Opana ER benefits no longer outweighed its risks.

The FDA’s decision came after the Centers for Disease Control and Prevention reported that Opana ER, reformulated to be harder to crush and snort, was still fairly easy to melt and inject. Opana ER abuse was implicated in a 2012 HIV and viral hepatitis outbreak in Indiana as well as a rare, and potentially fatal, blood disorder. Older forms of oxymorphone, including the original version of Opana (now generic) will still be available for pain patients who need them.

As health-care educators and professionals with experience in the industry, we support the FDA’s action, and the new direction it signals: that drug approval decisions should give greater consideration to population health.

The FDA should use this approach to re-evaluate drugs already on the market, plus new ones on the horizon. Policymakers need to rethink financial and legal advantages afforded to pharmaceutical manufacturers for new formulations of old drugs. ADFs are just as addictive as previous formulations of opioid medications and unfortunately have been associated with unintended harms and consequences.

Opana ER is also just one of the ADF versions of opioids on the market that turned older drugs into new profit centers for pharma companies. Creating a new version of a drug that is already generic or about to go off-patent is a common industry strategy. Some companies also file “citizen petitions” asking the FDA to block approvals of opioid competitors, claiming that generics and non-ADF brands were not safe on the market. When successful, this tactic can help maintain huge profits for pharmaceutical brands.

Previously, the FDA endorsed opioid-abuse technology innovations in the name of patient safety. For example, the FDA chose to block non-ADF, generic versions of OxyContin from entering the market when reformulated OxyContin launched in 2010. With a new patent in place until 2030, the 22-year-old OxyContin is still the major contributor to billions of dollars in annual profits for Purdue Pharma.

The Center for Public Integrity and the Associated Press report that ADF opioid makers spent record sums in recent years to influence policymakers, winning favorable Medicaid rebate provisions for ADF opioids and getting laws passed in 21 states mandating preferred insurance coverage for the new formulations. Gov. Christie vetoed one of these bills last year, citing a lack of outcomes data, but a similar Pennsylvania bill passed the House 190-3. It did not make it to Gov. Wolf’s desk, but has since been reintroduced as HB 288. Lawmakers have opportunities to address the opioid epidemic through numerous evidence-based policies; this bill is not one of them.

Our hope is to see an opioid-approval “reset” that protects the public health through regulations, increased post-marketing surveillance of outcomes, and more attention to how these drugs are promoted. A new expert scientific report commissioned by the FDA calls this type of focus “opioid exceptionalism.”

The FDA needs to revisit its 2015 guidance to drugmakers on how ADF opioids can be promoted to prescribers, in light of a 2016 survey of primary-care physicians showing that almost half wrongly think that these formulations are “less addictive.” This is a red flag that prescribers have gaps in their education, and suggests that a fresh look at marketing messaging may be needed as well.

Opioid manufacturers are also under additional state-level scrutiny from a bipartisan group of attorneys general, including Pennsylvania Attorney General Josh Shapiro. Shapiro joined a group of state attorneys general in July in announcing a new investigation of the marketing of opioid pain medications.

In the end, a population-level approach to our nation’s addiction and pain-management challenges must be much broader than opioid formulations or how they are marketed. New FDA Commissioner  Scott Gottlieb recently held a two-day meeting of scientists and medical experts to address research needs and the gaps in evidence. His commitment to a new risk-benefit framework for drug oversight will require more comprehensive public health surveillance, data analysis, and swift action in response to new evidence.

Most important, policymakers and payers should implement proven harm-reduction interventions and treatment modalities to address the opioid crisis, rather than being swayed by industry innovations that drive up drug prices without sufficient evidence of real-world benefits.

Gail Groves Scott, MPH, is the manager of a new Substance Use Disorders Institute at University of the Sciences’ Mayes College of Healthcare Business and Policy. A former pharmaceutical sales representative, she has years of experience on both the addiction medicine and pain management sides of the industry. Daniel Ventricelli, PharmD, MPH, is an assistant professor of clinical pharmacy at University of the Sciences’ Philadelphia College of Pharmacy.

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