September 06, 2018

Harris, Gardner Introduce Legislation to Hold Opioid Manufacturers Accountable

WASHINGTON, D.C. - Today, U.S. Senators Kamala D. Harris (D-CA) and Cory Gardner (R-CO) introduced the Accountability in Opioid Advertising Act, legislation that would direct the FDA to provide greater oversight over advertising and other promotion materials for opioid drugs. The legislation aims to refocus the FDA’s efforts to fight the opioid epidemic by ensuring that these marketing materials don’t mislead consumers and exacerbate the existing crisis.


Misleading marketing about the safety and efficacy of opioids helped create and magnify the opioid epidemic; yet, opioid manufacturers have avoided serious accountability for their practices. Since the late 1990s, pharmaceutical companies have reassured the medical community and the public that patients would not become addicted to prescription opioid pain relievers, vastly underplaying the drugs’ risks and exaggerating their benefits. Doctors began to prescribe opioids at increasing rates—in 2015, prescriptions for these drugs were three times what they were in 1999—and patients continued to believe the pills they were using were safe and effective. Meanwhile, opioid overdose rates sharply increased through the 2000s, leading to what is now the deadliest drug crisis in United States history.


“We must continue to find new ways to respond to the opioid crisis with the seriousness this epidemic deserves,” said Senator Harris. “Manufacturers who are using misleading marketing materials about the efficacy of these drugs continue to take advantage of consumers and magnify the crisis so it’s clear the FDA needs to prioritize using its enforcement mechanisms to help provide transparency and accountability. This legislation builds off my office’s ongoing efforts to tackle this crisis, and I believe will put us a step closer toward stabilizing it.” 


“As we continue to combat the opioid crisis on several fronts, we need to make sure that advertisements for medication are accurate and transparent,” said Senator Gardner. “We have to work together to do more to make sure individuals understand what they are taking and what effects it may have. I was glad to work with Senator Harris on this bipartisan legislation to hold drug companies accountable for their advertisements and to make sure patients understand the medical efficacy of the medications they are taking.”


The Accountability in Opioid Advertising Act would direct the FDA, within its existing authority, to prioritize review of advertising and other promotional materials for drugs for serious, life-threatening diseases or conditions or substance use disorders, especially opioid drugs and drugs used for medication-assisted treatment.


This legislation follows an investigation Senator Harris launched last fall into Alkermes, a pharmaceutical manufacturer, regarding its aggressive marketing efforts to boost sales of Vivitrol, a medication-assisted treatment for opioid addiction.


In February 2018, Senators Harris and Cantwell introduced the Comprehensive Addiction Reform, Education, and Safety (CARES) Act, which strengthened federal penalties on drug companies that fail to monitor and report suspicious opioid distribution practices, while also increasing transparency for existing federal oversight of opioid manufacturing and advertising. The Accountability in Opioid Advertising Act complements the CARES Act by ensuring robust FDA enforcement of opioid marketing practices.


Text of the bill can be found HERE