OR WAIT null SECS
With over 70 companies manufacturing immediate-release opioids in the United States, federal regulators may look to limit, or at least impose greater control over, marketing as a strategy to reduce the prescription, and more specifically, the improper and/or over-prescription of opioids.
After months of mixed signals, President Donald Trump stated in an October 2017 speech that he would declare a national health emergency to address the nation’s opioid epidemic. Less than a week after the President’s announcement, a presidential blue ribbon commission offered its own report on the opioid crisis, recommending that the president focus on three goals: 1) preventing addiction, 2) providing treatment for those already addicted, and 3) developing new non-addictive medications. Both the decision to announce this national health emergency and the recommendations of the blue ribbon commission appear to signal that the federal government does not intend to directly target the pharmaceutical industry in its efforts to curb opioid addiction. However, certain recommendations foreshadow the potential for increased regulation of marketing and increased litigation involving manufacturers of opioids.
With over 70 companies manufacturing immediate-release opioids in the United States, federal regulators may look to limit, or at least impose greater control over, marketing as a strategy to reduce the prescription, and more specifically, the improper and/or over-prescription of opioids. Indeed, the commission’s report noted that “[c]onstant vigilance is necessary to recognize if marketing efforts are suppressing scientific evidence.” That being said, the commission did not offer any concrete proposals for restricting the marketing of opioids. Instead, the report focuses on preventing opioid addiction through “a wide-reaching, national multi-platform media campaign addressing the hazards of substance use.” Significantly for the pharmaceutical industry, the report seeks collaboration with the private sector to achieve this goal.
Both the declaration of a national health emergency and the final report of the blue ribbon commission reflect a desire to work with the manufacturers of pharmaceuticals in other capacities as well. For example, in his October speech the President specifically praised the National Institutes of Health for a public-private partnership intended to develop non-addictive painkillers. Similarly, the blue ribbon commission encouraged the National Institute on Drug Abuse to “continue research in concert with the pharmaceutical industry to develop and test innovative medications” for treating those addicted to opioids. This latter recommendation may serve to invigorate opportunities for manufacturers of other therapeutics.
The commission’s report also addresses possible sources of funding to address the crisis. Specifically, the commission proposes two avenues for funding, both of which are directed to public health programs. 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.”
One concern for pharmaceutical manufacturers is the negative attention that President Trump’s declaration is bringing to the industry. There is little doubt that American presidents can influence public opinion and that presidential communications-from executive orders to tweets-may skew the perception of consumers. In his October announcement, the President has declared this to be an “emergency,” referenced a “truly evil” pharmaceutical, and referenced “people and companies that are hurting people.” Such statements raise concerns about not only casting a negative shadow on the pharmaceutical industry as a whole, but also spurring additional litigation. Even within the context of ongoing litigation, this negative taint cannot be considered helpful in the context of pre-trial publicity in any cases involving pharmaceuticals and pharmaceutical manufacturers.
Overall, both increased regulation and negative media attention represent future challenges for the pharmaceutical industry as the federal government continues to address the opioid crisis. However, the government’s espoused eagerness to work with the private sector suggests that manufacturers may have a significant voice as the industry works to curb abuse while still providing treatment to those suffering from chronic pain.
David B. Sudzus is a partner in Drinker Biddle & Reath LLP’s Chicago office and focuses his practice on products liability, mass tort, pharmaceutical, medical device and asbestos litigation and class actions. He represents manufacturers of medical devices and other products in single and multidistrict cases across the U.S. Dave also advises companies in preparing product manuals and warning labels, and in developing and implementing product-recall programs. He can be reached via email at firstname.lastname@example.org.
Russell J. Chibe is a products liability litigator at Drinker Biddle & Reath LLP, with a focus on the pharmaceutical and medical device industries and asbestos litigation. Russ also advises companies regarding consumer product testing and certification as well as product manuals and warning labels. In addition to his products liability practice, Russ provides consultation to the brewing industry on a variety of legal matters. You can follow him on Twitter at @RussChibe or contact him via email at Russell.email@example.com.