Former Food and Drug Administration Commissioner Scott Gottlieb said Juul is in a “tough spot” to get approval. Gottlieb said the product’s history with teen use and allegations of marketing to youth will give Juul a difficult path in the application and FDA-approval process. E-cigarette makers need to submit applications within 10 months to continue selling their products. (CNBC)
President Donald Trump is reportedly planning to issue an executive order to address healthcare price transparency on Monday. The order would direct federal agencies to create regulations that require insurers, doctors, hospitals and others to provide information about the negotiated cost of care. (Wall Street Journal)
The FDA is expected to approve Amag’s female sex-drive drug, Vyleesi. The drug would be a new, take-as-needed injection for low sex drive in women. The FDA approved the first women’s libido drug in 2015, Addyi, which is a daily pill. (NBC News)
A healthcare value nonprofit said the price of Novartis’ multiple sclerosis treatment is too high. The Institute for Clinical and Economic Review said the $88,561 list price for Mayzent did not match the benefits that patients receive from the treatment and recommended that Novartis lower the price. (Reuters)
Pharma’s lobbying succeeded in watering down legislation to tackle drug-patent “thickets.” The bill would have addressed drugmakers’ practice of obtaining a large number of patents, called patent thickets, to protect their exclusivity and extend their pricing monopoly. (STAT)
