chevron-down Created with Sketch Beta.

Public Contract Law Journal

Public Contract Law Journal Vol. 52, No. 2

A Prescription for Calamity: Why the Department of Labor's Pharmacy Benefit Management Program Falls Short as a Singular Solution to the U.S. Opioid Crisis

Davis Nicole Madeja


  • Provides background information concerning the impact of the opioid crisis and the impact of COVID-19 on the rates of misuse and addiction in the United States
  • Analyzes the Department of Labor's Pharmacy Benefit Program, addressing the singularly preventative nature of the program, which fails to support a holistic solution
  • Addresses concerns relating to the use of pharmacy benefit management services in general, particularly the cost-increasing nature of such mechanisms
A Prescription for Calamity: Why the Department of Labor's Pharmacy Benefit Management Program Falls Short as a Singular Solution to the U.S. Opioid Crisis
smartstock via Getty Images

Jump to:


The purpose of this Note is to create a holistic solution for the U.S. Department of Labor to apply amidst the United States’ ongoing opioid crisis, which will serve to both prevent addiction before it can develop and treat existing cases of addiction. To this aim, this Note examines and analyzes the connections between the opioid crisis and another co-existing public health crisis, the COVID-19 pandemic, and the procurement procedures taken to resolve them.

The argument is developed throughout three sections. First, this Note provides background information demonstrating the detrimental impact of opioid misuse and addiction, as well as the impact that COVID-19 in particular has had on rates of misuse and addiction in the United States. Additionally, this section introduces efforts taken to resolve the crisis, including the Department of Labor’s Pharmacy Benefit Management program, which is the subject of this Note.

Second, this Note examines the Department of Labor’s Pharmacy Benefit Program, addressing the singularly preventative nature of the program, which fails to support a holistic solution. Additionally, this Note addresses concerns relating to the use of pharmacy benefit management services in general, particularly the cost-increasing nature of such mechanisms.

In the final section, following an examination of the procurement procedure used to acquire COVID-19 vaccines, this Note proposes the application of a similar pharmaceutical procurement approach to combatting the opioid crisis. To conclude, this Note argues that by contracting with pharmaceutical companies to develop a safer and less addictive treatment plan, the Department of Labor would be able to prevent, as well as treat, opioid addiction.

I. Introduction

Since the outbreak of SARS-CoV-2 (COVID-19) at the start of 2020, national attention has remained fixed on the global pandemic, ongoing or reemerging mask mandates, recent distributions of vaccine boosters, and the near constant search for a more permanent solution to the tragedy and turmoil, for a reprieve from the “new normal.” COVID-19, however, is not the only major health crisis with which the United States currently contends. The opioid crisis, which emerged in the 1990s, still persists and has only garnered momentum as a result of the ongoing COVID-19 pandemic. Yet, as we have moved closer to finding a solution to COVID-19, a similar comprehensive solution to the opioid crisis remains out of reach. As the rates of opioid addiction and opioid-related casualties continue to rise, it is clear that the need for such a solution has become all the more pressing.

One of the most recent initiatives implemented to resolve the nation’s opioid crisis is the Department of Labor’s Pharmacy Benefit Management Program, designed to reduce the cost of pharmaceuticals and to provide claimants, particularly those receiving opioid prescriptions, with greater regulation and oversight. The program adopts a variety of measures intended to prevent opioid addiction before it begins. However, such guidelines will not serve to resolve the overall crisis. The shortcomings of this program ultimately reflect the narrow approach taken by previous federal agencies over the past several decades. Given the impact that the opioid crisis continues to have on the United States, the Department of Labor must find a solution that will not only prevent but treat addiction. Recent successes in responding to the COVID-19 virus are greatly attributed to the procurement of vaccines. For this reason, the Department of Labor should aim to develop a safer treatment mechanism via pharmaceutical procurement, which would offer a solution to the overall crisis.

First, this Note will provide a brief background on the impact of the opioid epidemic, the relationship that has developed between the two co-existing crises, and federal efforts to resolve opioid addiction in the United States. Then, this Note will examine the Department of Labor’s newly implemented Pharmacy Benefit Management program and its failure to provide an adequate solution to the opioid crisis. Next, this Note specifically analyzes the merely preventative approach of the Pharmacy Benefit Management program and evaluates the concerns of cost increases ascribed to pharmacy benefit management in general. Further, this Note will then discuss the procurement approach used to obtain vaccines to successfully prevent and treat the COVID-19 virus. Finally, this Note will argue that the Department of Labor should implement a similar pharmaceutical procurement approach resulting in the development of a safer and less addictive opioid medication that will serve not only to prevent opioid addiction, but to treat those already suffering from addiction as well.

II. Background

A. The National Opioid Crisis at a Glance

During the 1990s, the rates at which opioids were prescribed to patients across the country began to substantially increase. Unfortunately, this class of pain-relieving drugs has had a devastating national impact. According to the Centers for Disease Control and Prevention (CDC), “From 1999 to 2020, more than 263,000 people died in the United States from overdoses involving prescription opioids,” and “Overdose deaths involving prescription opioids have quintupled since 1999.” In 2019 alone, 48,006 people lost their lives to overdoses involving the use of synthetic opioids other than methadone, and another 14,480 deaths were attributed to overdoses involving the use of heroin.

Despite the readily apparent dangers of prescription opioids, it is clear that these drugs hold an important place within our healthcare system. They serve as a necessary evil in combating a multitude of medical conditions such as chronic pain, and pain management more generally. It is estimated that twenty percent of patients seeking assistance from physicians due to “noncancer pain symptoms or pain-related diagnoses (including acute and chronic pain),” are prescribed opioids as a means of relief. While evidence supports the efficacy of the short-term use of opioids for such patients as described above, little research has been done to examine the pain management benefits of long-term opioid use. Regardless of the crucial role opioids play in pain management, given the undetermined efficacy and lethal side effects of long-term use, it is time to invest in a solution, namely safer and more effective alternatives. The necessity of such alternatives has only become more apparent as the United States contends with a global pandemic.

B. The Impact of COVID-19 on Opioid Addiction

As the nation continues to confront the resulting social and economic effects brought by the COVID-19 pandemic, now more than ever there is a need for resolution of the opioid crisis. According to the American Psychological Association, substance abuse, including the misuse of opioids, has become more prevalent throughout the still ongoing pandemic, likely as a means of coping with stress and other emotions induced by current circumstances. Given the rise in substance use and misuse resulting from the pandemic, it should also come as no surprise that the rate of both fatal and non-fatal overdoses has increased as well. According to research conducted by the National Institute on Drug Abuse, individuals with substance use disorders and those in recovery were one and one half times more likely to have COVID-19 than those who did not, and those same individuals were more likely to experience severe outcomes of COVID-19, including hospitalization and death.

C. Federal Efforts to Curb the Crisis

On January 18, 2022, in the midst of the COVID-19 crisis, the Biden administration made a public statement regarding the actions that have been taken to address the addiction and overdose epidemic. Such actions include efforts targeted specifically at prevention, harm reduction, treatment and recovery, and supply reduction. The current administration’s plan to address these issues is not the federal government’s first attempt at resolving the ongoing opioid crisis. For example, there are fifty-seven federal programs responsible for funding efforts designed to address the opioid crisis. For years, appropriations to opioid response programs have regularly been administered by the Department of Health and Human Services to fund research, criminal justice initiatives, public health surveillance, and supply reduction efforts. However, despite this relative abundance of federal funding, the crisis persists, leaving many agencies still searching for a solution.

Most recently, in February 2021, the U.S. Department of Labor contracted with PMSI, LLC d.b.a. Optum Workers’ Compensation Services of Florida (Optum), to provide Pharmacy Benefit Management (PBM) services for claims under the Federal Employees’ Compensation Act (FECA) Program. According to a FECA Bulletin post published in March 2021:

Pharmacy benefit managers are third-party administrators (TPA) of prescription drug programs for commercial health plans, self-insured employer plans, Federal and State government employee health plans. PBMs are primarily responsible for developing and maintaining formularies which include an approved listing of prescriptions, contracting with pharmacies to increase enrollment, negotiating discounts and rebates with drug manufacturers and processing and paying prescription drug claims.

It is for this reason that the Department of Labor contracted with Optum to provide such services to, among others, claimants currently receiving ninety MED (Morphine Equivalent Dosage) or higher of prescribed opioids. As with many of the federal government’s current and previous efforts to curb the opioid crisis, the FECA program warrants justifiable scrutiny due to the shortcomings of both this new program and other PBMs.

III. The Department of Labor’s Pharmacy Benefit Management Program

It is not unreasonable to believe that greater regulation, through the Department of Labor’s Pharmacy Benefit Management program, of prescribed opioids might serve as an adequate tool in this ongoing crisis. However, given the program’s relatively recent implementation and rollout, it may be too soon to reach conclusions regarding the program’s ultimate long-term success. Based upon the information that has thus far been provided by the Department of Labor and the perspectives of experts in relevant fields relevant, it appears unlikely that the implementation of a PBM program will succeed on its own.

A. Pharmacy Benefit Management in Practice

Following the implementation of the program in February 2021, the FECA program first began mailing welcome letters introducing the program to all FECA claimants in April 2021. Employees who were injured while performing their duties received pharmacy cards, which make it possible for claimants to receive their prescribed medications through the program. More recently, however, in November 2021, the Department of Labor published various policies guiding the FECA program and dispensation of pharmaceuticals, including prescription opioids.

Initially, the Department of Labor incorporated a drug formulary system to enhance the management of claimants’ treatment. A FECA Bulletin details the program’s prescription management policies:

A drug formulary is a continually updated list of medications and related products supported by current scientific research. The formulary’s goal is to assist prescribers in the selection of safe, effective, and affordable medications. The drug formulary system is designed as a list of medications FECA will cover, and includes additional prescribing and dispensing guidelines for prescribers and pharmacies to further safe and effective medication use. This includes the application of prospective, concurrent, and retrospective drug utilization review (DUR), and prior authorization for non-formulary medications.

Prescribers will be able to rely on this formulary, which is currently set to be updated on a quarterly basis, when treating and assisting claimants. Although the formulary appears to have been designed with prescribers’ needs in mind, the Department of Labor also mandated that prescribers notify claimants of any changes in the formulary that may affect them and their treatment, such as if a product is removed from the formulary due to changes in the pharmaceutical market or new safety information.

Most notably, as described in FECA’s definition of a drug formulary system, the Department of Labor has incorporated drug utilization review practices into their new program. According to one pharmacist employed by Genex Services, a health care cost-containment and disability management services provider, PBM programs stand no chance at success without the incorporation of a drug utilization review component.

According to the Genex pharmacist, when pharmaceuticals are running through a PBM firm, a patient necessarily receives oversight from a pharmacist who will have the training and tools to identify whether or not the medication prescribed is consistent with a given individual’s condition and diagnosis as presented. As such, a pharmacist would be able to determine whether or not an opioid is the correct prescription to administer. For example, the pharmacist may be able to determine that, because an individual’s surgery was not invasive, an opioid prescription is not necessary. Overall, the Genex pharmacist expressed confidence that greater pharmacist intervention would lead to the prescription of more successful and safer pharmaceutical regimes.

Additionally, with access to an individual’s medical history, a pharmacist will be more successful in identifying contraindications, such as a pre-existing medical condition or the use of another medication that would make the use of an opioid unsafe for a patient. This information is useful because it will prevent patients from using medications that are particularly likely to be harmful.

From these policies set forth by the Department of Labor, it appears that the regulation and drug utilization review are more complex with respect to the initiation of opioid therapy for new claimants. For a new opioid prescription recipient, or an individual with no documented claims for opioid prescriptions with the FECA program in the past 180 days, the program will additionally consider the guidance provided by the CDC.

For example, FECA prohibits the issuance of more than two opioids at the same time, as well as the prescription of extended-release or long-acting opioids. As such, for the foregoing reasons, and although not explicitly stated, the Department of Labor appears to hold its new PBM program out solely as a tool in preventing the misuse of opioid prescriptions and the possible development of a substance abuse disorder.

B. Pharmacy Benefit Management as a Preventative Measure

Given the applicability of both the FECA guidelines and the adopted CDC guidelines to new opioid users, the program appears to be largely targeted at preventing addiction for claimants who have been prescribed opioids for treating workplace injuries, ideally, in the short term. For example, the program will not make an allowance for a new opioid user with non-cancer pain for more than one seven-day supply of an on-formulary, or an immediate release opioid prescription, without prior authorization for such an allowance. Further, such an allowance of a seven-day supply may not exceed greater than ninety MME per day. After the seven-day supply has concluded, any subsequent fills will require prior authorization. It is at this point that prescribers and pharmacists will review claimant medical histories and other relevant factors to determine whether the continued use of the opioid prescription is necessary to the recovery process.

The preventative nature of Department of Labor’s PBM program is also implicit within the language of the program’s policies and guidelines alone. Section IV, Initiation of Opioid Therapy of the New FECA Prescription Management Policies, begins, “On September 9, 2019, the FECA Program instituted new controls on new opioid prescriptions (FECA Bulletin No. 19-04).” It continues: “This policy will apply to new opioid users starting December 9, 2021.” The following guidelines both provided by the FECA program and drawn from existing CDC guidelines for the prescription of opioid medications apply to those who do not currently suffer from opioid addiction and seek to prevent addiction as a result of the prescription.

While Section V of these policies discusses the application of retrospective drug utilization review (DUR) (i.e., the review of drug therapy after the claimant has received a medication), such guidelines still appear to apply to claimants who entered the program as new opioid users and later meet or exceed ninety MME per day. Per the language of the guidelines, “[T]his is an opioid dose where the CDC recommends providers should avoid or carefully justify a decision.” However, this language does not suggest that addiction has set in in such cases, but simply that these claimants require stricter review due to how they have responded to the opioid treatment prescribed thus far.

The ninety MME Review Program’s guidelines contain markedly less detail than those put in place for new users. Following case review and, if medically necessary, the authorization of a short course of opioids, the program will use drug use evaluations (DUE), qualitative evaluations of drug use and prescribing, to perform retrospective drug utilization review to determine the appropriate drug therapy. This process is completed through the assessment of a claimant’s medical records and prescription history, leading to the identification of areas for prescription improvement. Once this process has been completed, non-opioid therapies, dose adjustments, naloxone, proper opioid weaning, or other guideline-driven suggestions to the treating provider may be recommended.

Yet, these particular guidelines are not outlined within the FECA program’s policies. Even in cases where addiction has set in, there is an unmistakable lack of clarity as compared with the guidelines put forward for new users. There is no definitive course of action or treatment plan, but instead a plethora of unresolved questions for those currently battling addiction.

Given the seemingly preventative (and singular) nature of the Department of Labor’s implementation of the FECA program, it is difficult to foresee pharmacy benefit management successfully serving as the sole initiative to resolve the opioid crisis. This is also largely due to the overwhelming concerns surrounding PBM programs more generally, which many suggest serve the singular purpose of multiplying costs for both the purchasers of medications and their patients.

C. The Shortcomings of Pharmacy Benefit Management

Despite the potential benefits brought about through the implementation of a PBM program, such as the tools effectively designed to limit the use of opioid prescriptions for new recipients before addiction has the chance to set in, the drawbacks of pharmacy benefit management should not be ignored.

Originally designed in the 1960s to process claims for insurance companies, according to advocates of PBMs, they now serve the primary purpose of lowering prescription drug costs for patients and sponsors such as the federal government. Critics of PBMs, however, take the contrasting position that, while they may lower costs for corporations, PBMs significantly increase the costs imposed upon patients themselves. According to the Pharmaceutical Care Management Association, “PBMs will save health plan sponsors and consumers more than $1 trillion on prescriptions over 10 years.” This cost-reducing tool, PBM supporters generally argue, will lead to more successful health outcomes for patients in the long run.

Yet, many have argued that reducing costs should not be the primary concern of agencies hoping to make an impact on the opioid crisis. In the opinion of the Genex Services pharmacist, many plans like PBMs fall short and become less effective when the primary purpose of implementation is to pay for pharmaceuticals at reduced costs. In their opinion, there may be an enormous financial incentive in considering additional concerns. For example, this may include taking into account of the welfare of employees and ensuring that employees are able to safely return to work following a workplace injury.

Conversely, others have argued that PBMs are not actually cost-saving mechanisms to begin with, but are instead cost multipliers due to the complex and polarizing nature of rebates. PBMs work with drug makers to develop the formulary. In the process, PBMs negotiate, and are incentivized by, manufacturer rebates—which they keep in part or in whole. “The more expensive the covered drug, the higher the rebate. And while the term ‘rebate’ usually means the buyer receives some money back post-purchase, this is not the case for prescriptions. The patient and the insurer buy the product but the PBM receives the rebate.” PBMs will often structure their contracts to allow them to collect and keep rebates as part of an “administrative fee” or “rebate sharing” arrangement with the health plan instead of passing the rebate to its rightful owner—the purchaser of the medication.

Drug manufacturers argue that they have been given no choice but to raise the list prices for their products due to the growing rebates they pay to PBMs. “According to a recent analysis, manufacturer rebates to PBMs increased from $39.7 billion in 2012 to $89.5 billion in 2016, partially offsetting list price increases.”

As a result of the above-described concerns regarding the use of PBMs, policy makers have proposed various reforms to better regulate PBMs, including requiring greater transparency around rebates, banning spread pricing, and requiring PBMs to pass through rebates to payers or to patients. In spite of these reforms, the implementation of pharmacy benefits management programs continues. Most recently, Mark Cuban’s self-named Cost Plus Drug Company (MCCPDC) has garnered scrutiny as a result of the company’s promises to keep pharmaceutical costs low (notably through the use of the company’s own PBM wing).

If pharmacy benefit management is raising the prices of prescription medications, including prescription opioids, such cost increases may negate the benefits of the regulation that PBMs provide by restricting access for those who are unable to afford such prescriptions. According to Travis N. Rieder, the Director of the Master of Bioethics Degree Program at the Berman Institute of Bioethics at Johns Hopkins University and author of the book In Pain, the opioid crisis will not be resolved by any attempts to restrict access to prescriptions. When prescription opioids become less accessible, those suffering from opioid addiction often turn to the black market where the supply is unpredictable due to the lack of regulation of the production of illegal drugs. As such, it is possible that such cost increases will only lead federal agencies further away from the goal of putting an end to the national crisis.

The Department of Labor’s Pharmacy Benefit Management program falls short in providing a meaningful resolution to the opioid crisis. Despite putting forth preventative measures for new opioid prescription users, the FECA program fails to provide a tangible solution for those already battling addiction. While cost reduction is not the Department of Labor’s singular focus, when considering both the overwhelming disdain for PBMs and the shortcomings of this program, the Agency should be reluctant to rely on pharmacy benefit management as a lone tool in this crisis. In confronting the COVID-19 pandemic, the federal government has pursued a variety of measures, including pharmaceutical procurement, to both prevent and treat the virus. The Department of Labor should follow suit by exploring alternative avenues through which we might fight the crisis as a whole.

IV. Pharmaceutical Procurement: A Holistic Solution to the Opioid Crisis

While significant government funding has been and continues to be dedicated to the research, education, and preventative efforts noted above, the United States government should be reluctant to proceed with these efforts alone. Instead, alternative routes to finding a more permanent solution to the ongoing opioid crisis should be the focus of the federal government’s efforts. The Department of Labor, in addition, or even opposed to, the implementation of the Pharmacy Benefit Management program for FECA claimants, should rely on pharmaceutical procurement as a means of both preventing opioid abuse and aiding in cases where addiction has already set in. Such a procurement-based approach has been applied in the course of the federal government’s response to the COVID-19 virus and has thus far had an overwhelmingly positive impact.

A. COVID-19 Vaccine Procurement

In the midst of the COVID-19, it is impossible not to consider the relative speed with which the federal government has responded to another public health crisis. This crisis similarly has yet to be resolved. However, much headway has been made in a short period of time to, when possible, both prevent the development of the virus and to limit its negative effects once contracted.

Not only has the federal government relied on measures, such as mask mandates, to prevent the spread of the virus and the possibly deadly results stemming from contraction, but the federal government has also made numerous efforts to immunize those in the U.S. from the virus altogether. For example, as the result of a partnership formed between the Department of Health and Human Services and the Department of Defense, Operation Warp Speed (OWS), money was awarded to several pharmaceutical companies to research and produce vaccines. Some vaccine candidates like Moderna, Janssen Pharmaceuticals, Sanofi/GSK, and Merck/IAVI received federal support for development. Other candidates like Pfizer/BioNTech (Pfizer) and Novavax participated in OWS through federal purchase of vaccine doses alone. However, OWS purchased all of the candidates’ vaccines, thereby making it possible to distribute doses at no cost to the American public.

Many of these companies, such as Pfizer/BioNTech, continue to produce several million vaccines which the government has procured for distribution to those in the United States. For example, in December 2020, Pfizer announced that it planned to deliver an additional one-hundred million doses of their vaccine by July 31, 2021, which the federal government agreed to paid $1.95 billion for.

Johnson & Johnson, one of the three vaccines authorized in the United States, has also provided their vaccine for approximately fourteen million people across the country. This quantity is despite the relatively bad press their vaccine received due to questions regarding its single-dose regime and comparatively easy storage requirements, as well as the brief pause mandated by the FDA and CDC in order to investigate several rare blood disorders that were speculated to have been caused by the virus.

The procurement of COVID-19 vaccines amounted to a complicated and expensive process involving multiple government agencies and multiple pharmaceutical contractors. While vaccine development typically takes ten or more years to complete, the federal government was forced to act quickly in order to respond to the COVID-19 pandemic. As described above, the OWS initially contracted with numerous pharmaceutical companies to acquire vaccines, and some agreements allowed the government to acquire (and therefore own) additional doses. This process was complicated by the largely unknown nature of the virus and required that the contractors submit their vaccines to various phases of clinical trials. While not every contractor passed the clinical trials, through the OWS initiative, the federal government was still able to acquire hundreds of millions of vaccines to distribute across the country. As of April 2022, approximately sixty-five percent of the U.S. population were fully vaccinated against the COVID-19 virus.

While the process to procure the vaccines used in fighting the COVID-19 pandemic proved taxing, the successful execution of this initiative demonstrates that such a procurement method can succeed. As such, the Department of Labor should adopt and apply a similar procurement model, working in conjunction with these major pharmaceutical companies, to develop a holistic solution to the opioid crisis.

B. Application of the COVID-19 Procurement Model to the Opioid Crisis

The pharmaceutical companies responsible for the production and distribution of COVID-19 vaccines, namely Johnson & Johnson, in conjunction with other companies including McKesson, Cardinal Health, and AmerisourceBergen, are also responsible for the production of prescription opioids in the United States. Recently, these four companies were sued by various communities that have been disproportionately affected by the opioid crisis in the largest settlement in a federal court case in American history, and reached a settlement agreement for $26 billion.

While these major pharmaceutical companies continue to produce and distribute potentially lethal opioid medications, efforts are being undertaken to develop brand new pain-killing therapies that in large part have yet to be implemented. For example, researchers at Astraea Therapeutics and the Wake Forest School of Medicine discovered a compound, known as AT-121 which, like opioids such as oxycodone, binds to the mu opioid receptor. Unlike opioids, however, AT-121 also binds to another opioid receptor which blocks the unwanted side effects commonly associated with opioid medications. In short, the discovery of this novel compound represents a potential advance toward the development of both non-addicting analgesics that are as effective as opioids, but without the liability, and a treatment alternative for opioid abuse disorder.

It is not necessary for the major pharmaceutical companies to go so far as to invest their time, effort, and financial resources into such experimental treatment programs. However, they should direct funding into research efforts to design a drug like Buprenorphine (often referred to by trade name Suboxone, among others), a medication already approved by the FDA to treat opioid addiction as a medication assisted treatment (MAT). This MAT method combines buprenorphine, an opioid with partial activity that blunts cravings, with naloxone, which reverses opioid overdoses and discourages opioid abuse. Statistically, those treated with buprenorphine have higher rates of success and are less likely to use opioids in the future. Given that buprenorphine is not a new drug and that doctors have been using MAT plans to treat those struggling with opioid addiction for years, such a reality seems to only reinforce the notion that such an undertaking would be well within reason for major companies like Johnson & Johnson, McKesson, Cardinal Health, or AmerisourceBergen.

As such, the Department of Labor should contract with these major pharmaceutical institutions to produce a prescription medication like Buprenorphine to distribute to FECA claimants, including both new opioid users and users already struggling with addiction. Given that the Department of Labor is permitted to engage in sole source procurement, it is possible that the agency would only need to contract with a single pharmaceutical company to meet the needs of FECA claimants, potentially simplifying the process of such a procurement. It is important to note, however, that sole source procurement differs from single source procurement. When the government engages in sole source procurement, this means that it has made the decision to use a single contractor to fulfill the corresponding need. The use of single source procurement alternatively implies that there is only a single source that the government can contract with to fulfill the corresponding need.

Given that there are multiple pharmaceutical companies, or contractors, with which the Department of Labor would be able to contract with to produce and then distribute a less addictive opioid, the agency would still need to be mindful of meeting competition requirements. As such, to contract with a singular pharmaceutical company, the Department of Labor would need to demonstrate that “the basis for not providing for maximum practicable competition is documented in the file . . . or [is] justified when the acquisition is awarded using simplified acquisition procedures.” While the agency should use caution when using sole source procurement, such procurement procedures would likely prove beneficial. For example, if the chosen contractor knows that it is the only source supplying such a product to the agency, and in mass quantities, it is possible that the company will be better incentivized to provide the medication at a more attractive cost.

As with the development and procurement of COVID-19 treatments and vaccines, there is no guarantee the development and procurement process of such a pharmaceutical product would be a smooth one. Such was the case for Merck, who initially contracted with the federal government to produce 1.7 million courses of an investigational antiviral COVID-19 treatment for $1.2 billion. However, the potential concerns that some may hold with respect to such a procurement does not mean that the objective should not be pursued, or that it is not worth pursuing to begin with.

C. Potential Challenges to Pharmaceutical Procurement

The process of pharmaceutical procurement may presents challenges and even raise concerns regarding the limits of government procurement itself. For example, pharmaceutical procurement could potentially reduce patients’ access to medications, result in lower quality treatments for patients, and decrease competition in a given market. Others have even suggested that it may be necessary to consider the potential pharmaceutical procurement has to infringe upon the intellectual property of the companies responsible for the production of the products procured given that these pharmaceuticals are patented inventions. These concerns are not the only ones, however, that contracting with pharmaceutical companies may inspire.

It is possible that the procurement of a medication like Buprenorphine would present unique challenges for the Department of Labor, particularly when contracting with major pharmaceutical institutions. The financial benefits that come from the production and distribution of pharmaceuticals, including prescription opioids, have always served as an incentive for companies like Johnson & Johnson to continue marketing and distributing these drugs. Despite the readily apparent dangers of these drugs, the companies’ profits generally overshadow the financial penalties that they face. These financial benefits then trickle down to doctors who are compensated for prescribing these medications to their patients who are then disincentivized from speaking out against pharmaceutical company practices.

When considering how insignificant the financial detriment is to these companies, some may question whether these dynamics are subject to change in the near future. Yet, skeptics should see these financial penalties and the public naming and shaming of these companies as a result of the ongoing opioid crisis as an incentive. By investing in the production of a less addictive pain-relieving pharmaceutical, the companies responsible for the crisis will be able to garner greater favor with the general public.

There may also be no doubt that the procurement of a safer, less addictive pain-relieving medication, even if successful, would present its own unique challenges. As has been seen through the procurement and distribution process of the various COVID-19 vaccines and treatments available in the United States, there is no guarantee that those who serve to benefit from such a pharmaceutical medication would willingly accept or abide by the prescription. It also seems possible that, given how relatively new many of the currently available alternative treatment options are, some users may be hesitant to accept such a pharmaceutical regimen. While Buprenorphine, for example, has long been distributed in emergency departments to patients presenting with symptoms of opioid withdrawal, more research is needed to determine whether long-term use, or MAT plans more generally, are safe.

As of late, research efforts have been taken to further develop generic versions of common naloxone products that will create an increased market supply. In February 2022, Optum reported that the FDA approved both a higher-dosage naloxone injection as well as a high-dose naloxone nasal spray. The company projects that the introduction of these products will reduce the average cost of generic alternatives, especially when compared to their name-brand counterparts. The FDA’s recent efforts to combat the opioid crisis do not stop there.

In August 2022, the FDA introduced a new Overdose Prevention Framework to develop and apply creative initiatives to prevent drug overdoses and the deaths that result from them. On September 23, 2022, the FDA announced efforts to expand access to naloxone products to harm reduction programs in order to build upon the goals of the Overdose Prevention Framework, particularly in underserved communities. This announcement came alongside the release of a statement from President Biden, outlining the current administration’s efforts to lessen the impact of the opioid epidemic, including significant financial contributions to both federal and state-level entities. While the distribution of naloxone products has been exempted and excluded from certain Supply Chain Security Act requirements, the scope of the distributions remains limited to medical emergencies. Although immediately implemented, it remains to be seen whether the FDA’s guidelines support the prescription of naloxone products for long-term, MAT plans.

Overall, a variety of concerns must be taken into consideration with respect to pharmaceutical procurement of a safer and more effective opioid medication, such as profit-driven pharmaceutical institutions and unresolved questions surrounding the proposed alternative treatment plan. However, given the overwhelming opioid-related devastation that continues to plague the United States, it is crucial that the federal government explore all avenues leading to potential solutions. As agencies like the CDC, and even companies like Optum, push for reform in pain treatment and management, it would be prudent for the Department of Labor in leading the country through this medical revolution.

V. Conclusion

Over the past several decades, the prescription and use of opioid medications, which have led to increasingly high rates of opioid misuse, addiction, and in many cases, death, have had an overwhelming and devastating impact on the United States. This has become even more apparent as the country simultaneously confronts the COVID-19 pandemic. Yet, while efforts to prevent and treat the COVID-19 pandemic have produced successful results, the country still has not found a similarly meaningful solution to the opioid crisis. This difficulty is largely due to the narrow focus of the efforts taken by the federal government both in the past and at present. The Department of Labor’s recent adoption of a Pharmacy Benefit Management program reinforces a similarly limited strategy. While the FECA program may provide measures to prevent opioid dependence for new users, it falls short as a holistic solution to the crisis by failing to provide a solution for those already struggling with addiction.

It is for this reason that the Department of Labor should implement a pharmaceutical procurement approach similar to that taken in the federal government’s response to the COVID-19 pandemic. By contracting with pharmaceutical companies to develop a safer and less addictive opioid medication like Buprenorphine, the agency would be able to provide a holistic solution to the opioid crisis. Significant efforts have already been taken to make possible the development of pharmaceutical regimens suitable to both treat and prevent opioid addiction. Now, the onus rests on the Department of Labor to effectively put these treatment methods to use by incentivizing major pharmaceutical institutions with the novel promise of both financial gain and good will to contribute to resolving the crisis that they have created.