Loyola University Chicago School of Law, JD 2019
After years in an opioid crisis, the United States now faces an opioid epidemic that has left the government and public desperate for relief and a workable solution. A group of senators hopes to be part of the solution with the introduction of a bipartisan bill that aims to better enable the DEA to establish opioid quotas. Despite already-present struggles to effectively manage its quota system and policies, the DEA would be given significantly more responsibility under this bill. Drug manufacturers, directly responsible for following DEA, FDA, and OIG regulations to hopefully resolve the epidemic, will need to grow their compliance efforts and create responsive solutions to remain both profitable and compliant.
The Opioid Crisis, and current strategies to end it
On October 26, 2017, acting HHS Secretary, Eric D. Hargan, declared a nationwide public health emergency regarding the opioid crisis. A problem since the 1970s, the opioid crisis in the United States is now a confirmed epidemic. HHS reports that in 2016 alone there were over 42,000 deaths from opioid overdoses and 2.1 million people with an opioid-use disorder, creating a $504 billion economic cost. After various federal and state actions to combat and help control the epidemic, HHS prioritized the following in its five-point Opioid Strategy in April 2017::
- Improve access to prevention, treatment, and recovery support strategies
- Target the availability and distribution of overdose-reversing drugs
- Strengthen public health data reporting and collection
- Support cutting-edge research on addiction and pain
- Advance the practice of pain management.
The American Medical Association (AMA), in recognition of “the need for increased physician leadership” in its own efforts to end the epidemic, created an Opioid Task Force. The task force encourages physicians to use drug monitoring systems, enhance training and education, support comprehensive treatments, aid in the elimination of stigma, prescribe naloxone (an overdose-reversing drug) to those patients at risk of overdose, and encourage safe medication storage and disposal.
Opioid quota reform
On Monday March 12, 2018, a bipartisan group of senators introduced a bill, the Opioid Quota Reform Act of 2018, that would allegedly “strengthen the Drug Enforcement Administration’s (DEA) ability to prevent opioid abuse.” With a current, limited ability to lower opioid quotas, the bill’s proponents claim that it would allow the DEA to weigh and consider abuse rates and overdose deaths in its annual quota setting for the Schedule I and II controlled substances manufactured and produced in the United States. Senator Dick Durbin of Illinois commented, “Opioid quota reform is needed so DEA can take important factors like diversion and abuse into account when setting quotas, rather than chasing the downstream consequences of this crisis.” In his reference to downstream consequences, Durbin implies that the introduction of quotas is an upstream solution, one that addresses “the underlying systemic causes, aspects, and issues at play.” The bill could move quickly, circumventing Congress through DEA’s administrative rule-making process. It is necessary to consider the compliance implications of this bill.
Complying with drug quotas
The DEA’s efforts to keep scheduled drugs under control culminates in the establishment of production quotas. The Controlled Substances Act allows the DEA to control the production of Schedule I and II drugs, including drugs used for research purposes. “These quotas—known as Aggregate Production Quotas (APQs), Bulk Manufacturing Quotas (BMQs) and Procurement Quotas (PQs)” set the legal production amount of each drug. However, the quota system has not always been well-received.
“In 2011 and 2012, many patients with attention deficit hyperactive disorder (ADHD) said they found it profoundly difficult to obtain FDA-approved ADHD treatments containing amphetamine salts, a DEA-controlled substance. In response to pressure from patients and legislators, DEA eventually increased its production quota on amphetamines intended for sale from 25.3 million grams per year to as much as 49 million grams per year in 2014.”
Critics of the DEA’s quota system argue that the troubles move beyond amphetamines and towards drug manufacturers. The quota system negatively impacts the drug manufacturers desperate to comply and maintain their businesses and profits. While manufacturers can make a direct request to the DEA for quota adjustments in the face of drug shortages, the Government Accountability Office (GAO) found that those requests for adjustments were often significantly delayed as compared to the DEA’s guidelines. GAO identified “significant weaknesses” in the DEA’s management of its quota process, namely that “[t]he agency frequently failed to meet regulatory deadlines for bulk manufacturing and procurement quotas, and on average took half a year to establish quotas in 2011 and 2012” A 2012 law requires the DEA to coordinate with the FDA to increase quotas. Therefore, in addition to the DEA’s troubles, “[m]anufacturers estimated that 17% of schedule II medicine shortages were caused by FDA between 2011 and 2013.”
The DEA’s Diversion Control Division sets the Aggregate Production Quotas (APQ) for Schedule I and II controlled substances, and requires that manufacturers of these controlled substances apply for a quota.
Drug manufacturers are expected to comply with quotas and the DEA’s process to obtain permission to manufacture their products. They must also remain abreast to changing quotas and laws in an effort to pro-actively prepare for increases and decreases that could dramatically affect production. They bear social and industrial responsibility for drug shortages and crises (like the opioid epidemic), but must also remain innovative and profitable through research and development and the sale of drugs that maintain their ability to invest in such endeavors.
While not America’s favorite healthcare institution (Business Insider reports that despite an overall improvement in public opinion, drug companies continue to have a “so-so” reputation), drug manufacturers are not exempt from thorough OIG, DEA, and FDA compliance regulations. They strive to balance their goals and objectives with governmental and internal compliance oversight encompassing all seven elements of compliance.
Would this bill create more compliance burden for drug manufacturers?
The proposed bill asks a lot of the DEA. Senator Grassley of Iowa, one of the bill’s backers, lists the following changes to the DEA’s process:
- Directing the DEA to consider additional factors and existing statutory considerations in quota development;
- Requiring the DEA to publicly defend any annual increase to an opioid quota;
- Requiring the DEA to publish manufacturer trends and authorizations to Congress; and
- Requiring the DEA to identify better methods for incorporating data collection and changes in accepted medical practices.
The DEA has documented struggles with adhering to its quota process and being able to assist the healthcare industry and drug manufacturers in responding to changes in drug availability. Is the introduction of more responsibility going to allow them to work with manufacturers, as they are expected to, and adequately respond to changes and developments in the opioid crisis and [hopefully] the crisis’ solution?
Drug manufacturer compliance leaders must continue to ensure that their companies follow all new and existing rules and regulations despite the delay from announcement to implementation and the difference in expected interaction with the DEA and reality.
Policies and procedures for DEA interaction will need restructuring, as the DEA’s response to its new reporting responsibilities will require data from manufacturers.
Monitoring and auditing will hopefully remain the same as manufacturers should already be tracking compliance with existing quotas. Perhaps an increase in the oversight of opioids will influence positive change in manufacturers.
It is hard to argue that efforts to combat the opioid epidemic should be questioned simply because they have a heavy impact on drug manufacturers. Those producing opioids should already be aware of the power they wield with such powerful, and presently deadly, medications supporting their business. Nonetheless, drug manufacturers must be aware that change is coming. Whether through this bill or the next, drug manufacturers will need to continuously work with the DEA to respond appropriately to the public and governmental demand for change, and with their own internal controls to ensure they remain compliant and prosperous.