Since the Covid-19 outbreak began, chloroquine and hydroxychloroquine have received much attention as potential treatments. Interest in the drugs first sparked in early March after reports of promising test results in French and Chinese studies. In the French study, researchers reported in a non-peer-reviewed draft paper that 14 of 26 Covid-19 patients in their study were virologically cured after two weeks of treatment with hydroxychloroquine and azithromycin. Similarly, the Chinese studies found that chloroquine phosphate “demonstrated marked efficacy and acceptable safety in treating Covid-19 associated pneumonia.”
However, those results were widely criticized as anecdotal and for failing to comport with traditional clinical drug development procedures, such as employing test subject randomization and double-blind testing with control groups and placebos. On April 3, the journal that published the French study withdrew its support and announced that the study did not meet its standards. Since those early results were first reported, the World Health Organization, numerous governments and other organizations have commissioned robust clinical trials to determine the drugs’ true effectiveness against Covid-19.
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Despite the criticism of the early studies and limited other evidence supporting their effectiveness against Covid-19, interest in chloroquine and hydroxychloroquine surged after President Donald Trump touted their potential in several White House press briefings and tweets in March. The Washington Post reported that mentions of hydroxychloroquine on social media went from zero in early February to 87,407 by April 6. During that same time, prescriptions for the drugs also skyrocketed. CBS News reported that “chloroquine orders spiked 3,000% in March and hydroxychloroquine orders rose 260%.”
But the dark side of the widespread interest in chloroquine and hydroxychloroquine has been the hoarding of the drugs by some medical professionals. Shortages have been reported across the country, prompting new, rapidly evolving regulations from various state and federal government authorities.
Chloroquine and Hydroxychloroquine Have Been Approved to Treat Other Illnesses for Decades
For several decades, chloroquine and hydroxychloroquine have been approved by the U.S. Food and Drug Administration (FDA) to treat illnesses such as malaria, lupus, and rheumatoid arthritis. Although the drugs are known to have severe side effects, such as heart complications, diarrhea, and dizziness, the Lupus Foundation of America wrote, “For many people with lupus there are no alternatives to these medications…. [H]ydroxychloroquine or chloroquine are the only methods of preventing inflammation and disease activity that can lead to pain, disability, organ damage, and other serious illness.” After becoming aware of the shortages, the foundation implored Congress to enact legislation to ensure that the drugs were available to patients who need them for non-Covid-19 illnesses.
HHS Designated the Drugs as Subject to Anti-Hoarding Rules
On March 23, President Trump signed an executive order delegating his authority under the Defense Production Act, including the power to promulgate rules to “prevent hoarding of health and medical resources necessary to respond to the spread of Covid-19,” to U.S. Department of Health and Human Services (HHS) Secretary Alex Azar. Secretary Azar has since designated chloroquine and hydroxychloroquine as scarce or threatened materials subject to special federal anti-hoarding protective measures.
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35 States Have Enacted Rules to Limit Hoarding
Additionally, 35 states have issued some sort of guidance aimed at preventing shortages of chloroquine and hydroxychloroquine, ranging from general statements in FAQs to executive orders to emergency regulations. Several states, including Idaho, Louisiana, Nevada, New York, North Carolina, Ohio, Oklahoma, Texas, South Dakota, West Virginia, and Wyoming, have gone as far as promulgating regulations modifying the circumstances in which chloroquine and hydroxychloroquine may be prescribed and limiting the number of pills that can be supplied with each prescription. For instance, Idaho’s rule requires prescriptions to include written diagnoses for illnesses that the drugs have been proven to treat and also limits prescriptions to 14-day supplies.
DOJ Is Leading a Covid-19 Hoarding and Price Gouging Task Force
On March 24, U.S. Attorney General William Barr announced the launch of the Covid-19 Hoarding and Price Gouging Task Force. AG Barr has required that each U.S. Attorney’s Office assign one representative to serve on the task force, which will coordinate with HHS to detect and take enforcement actions against companies and individuals who engage in price gouging or hoarding of scarce or threatened materials, including chloroquine and hydroxychloroquine.
The task force is part of the Department of Justice’s (DOJ) broader response to Covid-19-related unlawful conduct. In a memorandum issued on March 16, AG Barr instructed all federal prosecutors to prioritize the “detection, investigation and prosecution of all criminal conduct related to the current pandemic.”
Expect a Post-Pandemic Enforcement Sweep
Federal enforcement sweeps have followed every major natural disaster in recent memory and there is no reason to believe that the Covid-19 pandemic will be any different. For example, following Hurricane Katrina in 2005, DOJ and its federal partners oversaw federal enforcement efforts related to fraud committed in connection the devastating hurricane.
Indeed, AG Barr has already warned that DOJ “will investigate and prosecute those who acquire vital medical supplies in excess of what they could reasonably use.” If history is any indicator, expect the federal authorities to “aggressively pursue” medical professionals and others who hoard or unnecessarily prescribe chloroquine and hydroxychloroquine during the Covid-19 pandemic.
Photo: Moussa81, Getty Images
Sarah M. Hall is a former federal prosecutor and is senior counsel in Thompson Hine’s White Collar Criminal Practice, Internal Investigations & Government Enforcement group in Washington D.C.. She represents corporations and individuals in government investigations and prosecutions of alleged violations of the anti-fraud, procurement, FCPA, health care, sanctions, export control, securities, commodities and criminal tax laws. Prior to joining Thompson Hine, Sarah served for seven years with the U.S. Department of Justice, Criminal Division, Fraud Section as a white-collar crime and health care fraud prosecutor.
Steven A. Block is a partner in Thompson Hine’s White Collar Criminal Practice, Internal Investigations & Government Enforcement group in Chicago. With significant investigative and trial experience as a federal and state prosecutor, he focuses on internal investigations and white collar criminal and regulatory matters. Steven served as an assistant U.S. attorney and deputy chief with the U.S. Attorney’s Office for the Northern District of Illinois, where he investigated, prosecuted and supervised hundreds of cases involving a wide range of criminal offenses, including public corruption, financial crimes, bankruptcy fraud, tax evasion, insider trading and complex wire and mail fraud schemes.
Jamar T. King is an associate in Thompson Hine’s Business Litigation practice. His broad practices includes general commercial disputes, financial services litigation, and white collar criminal defense. A former assistant public defender for Montgomery County, Ohio, Jamar has successfully tried several cases and argued dozens of motions before multiple courts. He has also represented clients in both the mediation and arbitration settings.
