Cantwell Opioid Bill Gets Bipartisan Support from 39 Attorneys General
CARES Act would hold opioid manufacturers accountable for aggressive and misleading advertising, negligent distribution practices
Washington, D.C. – As the United States continues to grapple with the opioid and heroin epidemic, a bill introduced by U.S. Senator Maria Cantwell (D-WA) to hold drug manufacturers accountable for misleading advertising and negligent distribution practices today received the support of a bipartisan group of Attorneys General from 39 U.S. states and territories.
In a letter addressed to the Chairmen and Ranking Members of the Senate Health, Education, Labor, and Pensions (HELP) Committee and the Senate Judiciary Committee, the AGs highlighted the importance of holding drug manufacturers accountable and urged support for Senator Cantwell’s Comprehensive Addiction Reform, Education, and Safety (CARES) Act, provisions of which are also included in CARA 2.0, a comprehensive opioid education, treatment, and recovery bill co-sponsored by Senator Cantwell.
“CARES increases penalties on drug manufacturers that fail to report suspicious transactions and maintain effective controls against diversion,” the AGs wrote. “Diversion of prescription opioids has devastated communities in our states. The consequences for turning a blind eye to suspicious opioid orders cannot merely be a cost of doing business. We urge you to support CARA 2.0 and the CARES Act to ensure that penalties effectively hold manufacturers accountable and help stem diversion.”
The CARES Act strengthens federal penalties on drug companies that fail to monitor and report suspicious opioid distribution, while also increasing transparency into existing federal oversight of opioid manufacturing, advertising, and distribution. It increases the federal civil and criminal penalties on companies that fail to prevent their drugs from entering illicit markets, provides transparency about opioid manufacturers that break the law, provides resources to investigate bad actors, and authorizes additional funding to target and dismantle illicit heroin trafficking organizations. The bill is cosponsored by California Senator Kamala Harris.
The letter was signed by the Attorneys General of Ohio, Washington, Alaska, California, Colorado, Connecticut, Delaware, the District of Columbia, Florida, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Mexico, New York, North Carolina, North Dakota, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Vermont, the U.S. Virgin Islands, and Virginia.
The full text of the letter is available HERE and below.
Dear Chairs Alexander and Grassley and Ranking Members Murray and Feinstein:
State attorneys general have been fighting the opioid crisis on numerous fronts, including protecting consumers from deceptive marketing of prescription opioids, disrupting illicit trafficking networks and closing pill mills. Recognizing the scope of this crisis, we thank you for funding provisions of the Comprehensive Addiction and Recovery Act (CARA) 2.0. By providing expanded treatment, increased naloxone access for first responders, and support for veterans treatment courts, these funds will assist states like ours that are suffering greatly from the opioid epidemic. Following up on this critical issue, we respectfully request that you now help expedite passage of the CARA 2.0 Act of 2018 (S. 2456), sponsored by Senator Portman and a bipartisan group of colleagues, to further address the devastation this epidemic has caused in our communities and to help hold opioid manufacturers appropriately accountable. In particular, we write to highlight the need for Section 14 of CARA 2.0, which is also contained in a separate bill, the Comprehensive Addiction Reform, Education, and Safety (CARES) Act of 2018 (S. 2440), introduced by Senators Maria Cantwell and Kamala Harris.
CARA 2.0 and CARES increase penalties on drug manufacturers that fail to report suspicious transactions and maintain effective controls against diversion of their drugs to the illicit market. Specifically, the bills increase civil penalties from $10,000 to $100,000 per violation for negligence in reporting suspicious transaction activity. The bills also double the maximum criminal penalty from $250,000 to $500,000 for companies that willfully disregard or knowingly fail to keep proper reporting systems or fail to report suspicious activity.
Opioid manufacturers have a duty to ensure that they take steps quickly to prevent their drugs from entering the illicit market. Moreover, these companies, which know their market better than anyone, are well-positioned to identify suspicious activity. Opioid manufacturers can detect certain doctors who consistently prescribe many more opioids than their peers and facilities with sudden, significant increases in opioid orders. Company sales representatives directly observe warning signs, such as large numbers of patients paying in cash or prescriptions being given or sold to non-patients.
We have seen opioid manufacturers ignore their responsibilities. For example, in response to a 2007 multi-state settlement, Purdue Pharma promised to create an abuse and diversion detection program to detect and report atypical prescribing patterns. Despite the court order, Purdue has remained silent about suspicious prescribing activity it should have reported, including ignoring the warnings of their own sales representatives about particular physicians. In Washington, for instance, Purdue waited nearly three years after a sales representative raised concerns to report a physician to the DEA. The sales representative noticed that the physician operated a largely cash-based business. Purdue analyzed his prescribing patters and found that in the six months prior to the representative’s report, he wrote more than 1,000 OxyContin prescriptions worth nearly half a million dollars, far exceeding his peers. Rather than fulfilling their responsibility to report this activity promptly, the company continued to supply opioids for nearly three years.
Diversion of prescription opioids has devastated communities in our states. The consequences for turning a blind eye to suspicious opioid orders cannot merely be a cost of doing business. We urge you to support CARA 2.0 and the CARES Act to ensure that penalties effectively hold manufacturers accountable and help stem diversion.
Thank you for your consideration.
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