Trending News Today: Resignation of FDA Commissioner Shocks Pharma Industry

Yesterday’s stunning announcement by FDA Commissioner Scott Gottlieb, MD, that he will resign after nearly 2 years in the position to spend more time with his family sent shockwaves through the industry. STAT reports that the announcement will leave biotech and pharma executives, as well as health care investors, “nervous at best and frightened at worst.” The article notes that the uncertainty surrounds libertarian officials who were previously linked to the job prior to Gottlieb. These potential appointees had designs on limiting the FDA’s drug oversight and review process, which left pharma stakeholders concerned that the deregulation would be taken too far, according to the article.
The FDA has approved Spravato, a mind-altering treatment for depression that is related to the club drug Special K, for patients who failed to previously find relief with at least 2 other antidepressants. The Associated Press reports that the drug has high potential for abuse, similarly to its cousin ketamine. These medications can lead to psychotic episodes in those at high risk, but advocates are hopeful that Spravato can relieve the symptoms of depression in the most desperate patients, according to the article.
The FDA is raising concerns that CanaRX, a company used by more than 500 US cities, counties, and school districts to import cheaper drugs from overseas for their employees, is sending “unapproved” and “misbranded” drugs to US consumers, according to Kaiser Health News. The report noted that drug prices from pharmacies overseas can be lower by as much as 70% compared with the United States because costs are regulated by the foreign governments. The FDA did not clarify why it waited more than a decade to take action against the service, which has been used since 2004 by some US customers, and acknowledged there have been no reports of individuals being harmed by drugs received through CanaRx.

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