A devastating public health crisis fueled by opioids has been causing the deaths of more than 70,000 Americans each year. Illegal opioids are not the only culprits; as the Centers for Disease Control and Prevention (CDC) reported, nearly 30 percent of opioid-related deaths can be attributed to prescription opioids.
Federal and state governments have responded to this crisis with a barrage of laws, regulations, and guidelines designed to limit opioid prescribing and curb opioid use disorder and addiction. Meanwhile, the Food and Drug Administration (FDA) has been encouraging medical device and pharmaceutical manufacturers to develop products and technologies to prevent new cases of opioid abuse and to treat those addicted.
In addition to these legislative and regulatory activities, the U.S. Department of Justice (DOJ) has stated its commitment to “using every available tool to prevent overdose deaths and hold accountable those responsible for the opioid crisis.” The DOJ’s Consumer Protection Branch as well as the Drug Enforcement Administration (DEA), the FBI, and other federal and state prosecutors have been intensely scrutinizing opioid prescribing practices and beefing up enforcement efforts. Any high volume of opioid prescribing could trigger an investigation—and any provider in the continuum of care, not just the pill manufacturer or the physician prescribing the pills, could become the target of opioid-related claims, regulatory scrutiny, potential civil liability, and criminal penalties.
How We Can Help
As one of the leading health care law firms in the country, Epstein Becker Green knows the legal and regulatory challenges concerning opioids that health care providers face. We formed an opioid taskforce to keep clients apprised of regulatory compliance issues, as well as the risk of potential civil, criminal, and administrative penalties for noncompliance. Epstein Becker Green is adept at assisting health care providers in compliance issues and enforcement matters relating to opioids, guiding medical device manufacturers through regulatory processes so that their opioid-related products and technologies reach the market, and counseling employers across industries on dealing with opioids in the workplace.
The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act of 2018; the Comprehensive Addiction and Recovery Act; the Controlled Substances Act; the Food, Drug, and Cosmetic Act; the Eliminating Kickbacks in Recovery Act of 2018; and the CDC Guideline for Prescribing Opioids for Chronic Pain are just a sampling of the laws and guidance being used to combat the opioid crisis. Epstein Becker Green is familiar with these and other federal and state laws, regulations, and guidelines related to opioids, and we counsel health care providers, pharmaceutical manufacturers, distributors, and pharmacies on complying with them. Our services include, but are not limited to:
- Advising health care clients on establishing, and then following, proper opioid prescription practices and controls to deter inappropriate overprescribing and drug diversion
- Assisting health care clients with reviews and audits of physician prescription practices, marketing activities, and relationships with vendors and substance abuse treatment facilities
- Counseling health care clients on state-level oversight activities of opioid prescriptions, including state Prescription Drug Monitoring Program databases, and confirming that the clients’ prescribing practices comply with all applicable state and federal rules
- Advising hospitals on federal staffing requirements, state-led redesigns of hospital treatment and discharge processes for patients with opioid use disorders, and payment methodologies and funding to address the opioid crisis
- Providing advice on privacy and security issues in the opioid context, as well as the policies and regulations obstructing the sharing of sensitive patient information
- Counseling pharmaceutical manufacturers and distributors on their suspicious order monitoring and reporting obligations
- Defending clients in government investigations and litigation involving alleged violations of the federal Controlled Substances Act and related state pharmacy laws
- Advising pharmaceutical manufacturers on opioid Risk Evaluation and Mitigation Strategies (REMS) compliance and related issues
In addition, not only drug testing laws but also the Americans with Disabilities Act (ADA) restricts the circumstances in which employers can test for certain drugs in the workplace. Epstein Becker Green counsels employers on managing opioid-related issues that impact their workforce, including, among other things, assessing hiring practices and policies on drug use and addiction treatment to ensure compliance with the ADA and other workplace laws, advising on employee assistance programs, and negotiating with unions on opioid-related issues.
Representation in Enforcement Matters
As federal and state agencies and local law enforcement become increasingly aggressive toward violations of opioid standards, the world of opioids is a risky place to be. For instance, in 2018, the DOJ, in conjunction with the U.S. Department of Health and Human Services (HHS) Office of Inspector General, announced the largest health care fraud takedown operation in American history, and much of the takedown was directed at the ongoing opioid crisis.
Epstein Becker Green’s government enforcement attorneys have substantial experience representing pharmacies, hospitals, nursing homes, physicians, and other health care providers in investigations, lawsuits, and administrative actions by state and federal state agencies, including DEA investigations, audits, and compliance actions, relating to opioid prescribing practices and drug addiction treatment. For example, Epstein Becker Green is currently representing several clients in investigations by the DOJ and DEA alleging health care fraud involving opioids.
Guidance Through FDA Submission and Approval
For those medical device manufacturers seeking to bring their opioid-related product or technology to market, Epstein Becker Green, with the assistance of technical advisors from our affiliate EBG Advisors, a national strategy and management consultancy, offers a “one-stop shop.” We provide complete support on all regulatory and payment matters, including, among other things, assisting manufacturers in successfully navigating FDA regulatory submission, review, and clearance processes. For example, we helped a medical device manufacturer obtain marketing clearance for the first FDA-authorized device for managing opioid withdrawal symptoms. We also helped a pharmaceutical manufacturer design an opioid diversion risk mitigation program in anticipation of launching a new opioid drug product.