WASHINGTON – U.S. Senator Amy Klobuchar (D-MN) sent a letter to the Food and Drug Administration (FDA) regarding recent reports that opioid manufacturers misled physicians on the effects of OxyContin to increase sales. In the letter, Klobuchar asked FDA Administrator Scott Gottlieb to explain what steps the FDA is taking to address the use of deceptive sales tactics and fraudulent marketing by opioid manufacturers.
“I write in response to recent reports that executives at Purdue Pharma concealed the addictive nature of OxyContin through deceptive marketing and to ask what steps the Food and Drug Administration (FDA) is taking to protect consumers from the use of such tactics by opioid manufacturers,” Klobuchar wrote. “As litigation against the company continues, many have rightfully pointed out the role of OxyContin in sparking the opioid epidemic that has devastated communities across the country and claimed more than 200,000 lives since 1999—including more than an estimated 70,000 just last year. I look forward to your response on how the FDA is working to prevent more tragedies like the ones that have arisen from the improper marketing of OxyContin.”
As a former Hennepin County Attorney, Klobuchar has long led local and national efforts to curb drug abuse and help people overcome addiction. In October, three bipartisan bills Klobuchar led to combat the opioid epidemic were signed into law as part of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act. The Synthetic Abuse and Labeling of Toxic Substances (SALTS) Act, which Klobuchar introduced with Senator Lindsey Graham (R-SC), would make it easier to prosecute the sale and distribution of “analogue” drugs, which are synthetic substances that are substantially similar to illegal drugs. The Synthetics Trafficking & Overdose Prevention (STOP) Act, which Klobuchar introduced with Senator Rob Portman (R-OH) would help stop dangerous synthetic drugs like fentanyl and carfentanil from being shipped through our borders to drug traffickers here in the United States. The Eliminating Kickbacks in Recovery Act, which Klobuchar introduced with Senator Marco Rubio (R-FL), would help crack down on health care facilities or providers that try to game the system to take advantage of vulnerable patients.
Last February, Klobuchar, Portman, and Senators Maggie Hassan (D-NH), Sheldon Whitehouse (D-RI), Shelley Moore Capito (R-WV), Dan Sullivan (R-AK), Bill Cassidy (R-LA), and Maria Cantwell (D-WA) introduced the bipartisan Comprehensive Addiction and Recovery Act (CARA) 2.0 Act. The bill would increase the funding authorization levels for the CARA programs enacted in 2016 and put in place additional policy reforms to help combat the opioid epidemic. To build on the monumental first step of CARA, Klobuchar also introduced the Prescription Drug Monitoring Act, which would require the use of strong prescription drug monitoring programs (PDMPs) in all states that receive certain federal funding to combat opioid abuse and also requires states to make their PDMP data available to other states.
The full text of the letter can be found below:
Dear Commissioner Gottlieb:
I write in response to recent reports that executives at Purdue Pharma concealed the addictive nature of OxyContin through deceptive marketing and to ask what steps the Food and Drug Administration (FDA) is taking to protect consumers from the use of such tactics by opioid manufacturers.
These recent reports have revealed new details as to how Purdue Pharma executives concealed the strength of OxyContin from medical professionals after its launch in 1996. These latest reports follow previous reporting on the company’s misleading marketing practices and litigation in which the company and top executives pleaded guilty to criminal charges and agreed to pay roughly $600 million in fines. As litigation against the company continues, many have rightfully pointed out the role of OxyContin in sparking the opioid epidemic that has devastated communities across the country and claimed more than 200,000 lives since 1999—including more than an estimated 70,000 just last year.
In light of these deeply troubling reports, I respectfully request responses to the following questions.
- Since reports of the misleading and illegal marketing of OxyContin first came to light years ago, what actions has the FDA taken to deter and prevent pharmaceutical companies from misrepresenting the risk of addiction to medical professionals and consumers?
- What actions does FDA take to review the advertising, promotional materials, and educational materials for a particular drug prior to its dissemination? Has FDA made additional efforts to review these materials following these reports?
- Does FDA have data indicating whether its Opioid Risk Evaluation and Mitigation Strategy, which was issued in September 2018, has been effective in reducing the abuse and misuse of opioid painkillers, as well as the risk of addiction and overdose from these drugs? If not, does FDA have any plans to obtain such data?
I look forward to your response on how the FDA is working to prevent more tragedies like the ones that have arisen from the improper marketing of OxyContin. Thank you for your attention to this critical issue.