What’s Next In the Fight Against the Opioid Crisis?

David B. Sudzus and Russell J. Chibe explore possible outcomes of the Blue Ribbon Commission Report and the Declaration of National Health Emergency regarding the  U.S’s Opioid Crisis. 

Recent actions undertaken by President Donald Trump and his administration to combat the nation’s opioid crisis have sent mixed signals as to how the declaration of a “national health emergency” will affect the pharmaceutical industry.

His October 26 announcement that he would decline to declare a full-blown national emergency under the Stafford Act—opting instead for the “national health emergency” designation pursuant to the Public Health Service Act—suggests that manufacturers and marketers of pain medications will not be primary targets in the government’s fight against the opioid epidemic.

However, both the President’s statements and the subsequent recommendations of the President’s blue ribbon commission suggest that increased litigation for the pharmaceutical industry is a legitimate concern.

Building the right rescue strategy

The Trump administration’s strategy for combating the nation’s opioid crisis began to take shape in March 2017. At that time, the President issued an executive order establishing a blue ribbon commission to identify existing federal funds used to combat the opioid crisis, examine possible treatment services, report on best practices for addiction prevention, and evaluate existing federal programs addressing drug addiction.

In July, the commission issued an interim report recommending that the President declare a national emergency -- an act that would free up additional federal resources to address the problem.

Then-Health and Human Services Secretary Tom Price pushed back against this recommendation, suggesting on August 8 that “the resources that we need, or the focus that we need to bring to bear to the opioid crisis can be addressed without the declaration of an emergency.”

The President himself added to the uncertainty of the government’s intentions when he announced two days later that he instead agreed with the commission and would formally declare a national emergency. Following this announcement, the White House issued a press release adding that the President had “instructed his Administration to use all appropriate emergency and other authorities to respond to the crisis caused by the opioid epidemic.”

After all these mixed signals, President Donald Trump announced on October 26 that he would declare a “national health emergency” to address the nation’s opioid epidemic —a designation similar to but distinct from the “national emergency” he had previously stated he would declare. The distinction is important in large part because while the Public Health Service Act lifts certain restrictions in the event of a public health emergency, it does not provide significant government funds in the same manner that a national emergency under the Stafford Act would.

Indeed, in the wake of the announcement, Senator Edward J. Markey (D—Massachusetts) criticized the lack of resources cited by the President, objecting that “[i]nstead of a real commitment in the form of emergency funding for our states and communities, President Trump offered half-measures and few specifics.”

Shortly after the President’s announcement, on November 1, the President’s Commission on Combating Drug Addiction and the Opioid Crisis issued its final report outlining its suggestions for fighting the opioid crisis.

Consistent with the President’s remarks, the recommendations of the blue ribbon panel did not target the pharmaceutical industry in a punitive manner but rather focused primarily on three fronts: 1) preventing addiction, 2) providing treatment for those already addicted, and 3) developing new non-addictive medications.

Funding measures

The commission’s report also offers two specific avenues for funding. Initially, it calls on Congress to restart the Public Health Emergency Fund, a fund that provides money to fight public health crises but has been unfunded for the past several years. The report additionally recommends block granting funds for the epidemic to the states. According to the report, block granting “would allow more resources to be spent on administering life-saving programs.”

Both the President’s announcement and the commission’s recommendations suggest the Trump administration does not intend to target the pharmaceutical industry in their efforts to curb opioid addiction.

President Trump has consistently focused on treatment as the main vehicle for addressing the opioid crisis, and when he has taken a hardline stance, he has generally directed his ire toward foreign manufacturers of illicit opioid drugs and the gangs that distribute them.

As for legitimate manufacturers and distributors of pain medications, the administration frequently cites them as potential partners in the war on opioid addiction, lauding private companies that have been proactive in preventing fraudulent prescriptions and encouraging the development of non-addictive opioids.

Litigation concerns for pharma

While one of the biggest risks for manufacturers of pharmaceuticals to date has been regulatory actions and lawsuits against manufacturers of opioids, neither the President’s comments nor his blue ribbon commission’s report discusses these types of lawsuits in any substantial way.

Indeed, one concern about increased funding is that it may be directed to state attorneys general to further pursue civil actions against the pharmaceutical industry. The administration’s focus on addiction treatment and prevention, rather than litigation, tempers this concern.

However, there are still reasons to be concerned about potential additional litigation.

Initially, while much of the funding proposed by the President’s blue ribbon commission is directed toward treatment and public education, certain resources may still become available for states and municipalities interested in pursuing lawsuits.

Additionally, even without a mandate from the President, the Department of Justice may still unilaterally shift focus—and available funds—toward such litigation.

Indeed, the same day that the President gave his speech on the opioid crisis, the Department of Justice announced that it had indicted a pharmaceutical CEO for allegedly bribing doctors and pharmacists to prescribe a highly addictive opioid. Reports document that the CEO denies these allegations. Attorney General Jeff Sessions also recently created an Opioid Fraud and Abuse Detection Unit this past August, and while it claims to be focused on “pill mill schemes and pharmacies,” it is possible that the unit could redirect its attention to manufacturers.

Further, the spotlight that these actions shine on the opioid crisis may itself lead to both an increase in the filing of lawsuits and a potential influence on jury pools and juror perceptions.

While the President has generally focused on the pharmaceutical industry as a partner, he has made certain comments that paint the industry in a less-than-positive light.

For example, in his October 26 announcement, the President declared the opioid crisis to be an “emergency,” referenced a “truly evil” pharmaceutical, and referenced “people and companies that are hurting people.” Such language may serve to both encourage new lawsuits and tarnish the image of the industry with prospective jurors.

Just how the President’s statements and the administration’s actions shape future opioid lawsuits remains to be seen. However, given the inconsistencies of the Trump administration’s actions to date, executives and counsel in the pharmaceutical industry should continue to closely monitor the next steps the government takes in an effort to fight the nation’s opioid epidemic.