The Federal Trade Commission (FTC) unanimously voted to rescind its previous policy statements that opposed requiring pharmacy benefit managers (PBMs) be more transparent about their business practices, in today's bite-sized hospital and health industry news from the District of Columbia and North Carolina.  

• District of Columbia: Juul Labs last week said it was seeking FDA authorization of a new, next-generation e-cigarette. The device, which is already available for sale in Canada and the United Kingdom, includes age-verification capabilities and can prevent the use of counterfeit or unauthorized refill cartridges. According to Juul, the application for its new device avoids technical issues that led FDA to order the company's products off the market last year. The application includes research on how Juul's device exposes users to fewer carcinogens compared to cigarettes and that it can help adult cigarette smokers switch to a safer alternative. "We have designed a technological solution for two public health problems: improving adult smoker switching from combustible cigarettes and restricting underage access to vapor products," said Kirk Phelps, Juul's chief product officer. (Maloney, Wall Street Journal, 7/19; Reuters, 7/19)
• District of Columbia: FTC last week unanimously voted to rescind its past policy statements that opposed transparency regarding PBM business practices. Between 2004 and 2014, FTC published 11 reports and letters that discouraged disclosure and transparency rules, arguing that companies sharing such information would hinder competition. According to FTC Chair Linda Khan, these statements deterred states from implementing PBM transparency laws. "In light of this ongoing work [investigating the PBM industry], we want to make sure that prior statements that the FTC made are not being relied on in a way that could be impeding ongoing efforts at the state level or even at the federal level, to be examining the practices of these PBMs and, in some cases, requiring certain types of transparency or disclosure requirements," Khan said. In response, the Pharmaceutical Care Management Association (PCMA) issued a statement pushing back on FTC's decision. "In the absence of any new FTC guidance and considering the FTC's previous actions, it is critical to carefully protect data that helps maintain a competitive marketplace. Therefore, PCMA will continue to cite previous FTC studies, statements and enforcement actions that recognize the risks associated with proprietary pricing disclosure requirements that would limit pharmacy benefit companies' ability to manage costs for employers and consumers and would only serve to empower drug companies to raise costs," the organization said. (Reed, Axios, 7/21; Berryman, Modern Healthcare, 7/20)
• North Carolina: Last week, a tornado heavily damaged a major Pfizer drug manufacturing site in Rocky Mount, North Carolina. According to Pfizer, around one-fourth of the injectable medications it provides to U.S. hospitals, including drugs to block pain and fight infections, were produced at the facility. Although the company has not yet reported the extent of the damage at the facility, Erin Fox, senior pharmacy director at University of Utah Health, said it "will likely lead to long-term shortages while Pfizer works to either move production to other sites or rebuilds." So far, both Pfizer and FDA have sent teams to assess the damage at the site. "We are following the situation closely as it evolves and are working with the company to understand the extent of the damage and any potential impact to the nation’s drug supply," said Chanapa Tantibanchachai, an FDA spokesperson. (Jewett, New York Times, 7/20; AP/Modern Healthcare, 7/20)