FDA Halted 500 Foreign Prescription Drugs and Medical Device Shipments

Regulations

On Tuesday, the U.S. Food and Drug Administration announced that it prevented about 500 shipments of potentially dangerous illicit prescription drugs and medical devices from India from reaching American consumers. “Operation Broadsword,” which took place from Jan. 28-30, was the FDA’s first enforcement operation conducted in partnership with the Indian government.

More than 50 different FDA-regulated products were seized, including medications for cancer and HIV and opioid products. FDA Commissioner Dr. Stephen Hahn issued a very strong warning to consumers and physicians about the hazards of ordering pharmaceuticals and other health care products from unauthorized foreign sources. Standards and regulations vary from country to country, Hahn said, and the FDA cannot ensure the legitimacy, safety or effectiveness of products purchased abroad outside the FDA-regulated supply chain.

BeSafeRX is the FDA’s national campaign to raise awareness of the dangers of buying prescriptions from fake online pharmacies. While presented as authentic, these medications may be counterfeit, contaminated, expired, or otherwise unsafe.

For Women, Poor Sleep Associated with Unhealthy Eating

Women's Health

Research published Monday in the Journal of the American Heart Association found an association between poor sleep quality and higher calorie intake including increased consumption of sugar, saturated fat and caffeine. The year-long study of a racially and ethnically diverse group of 495 women age 20 to 76 tracked sleep quality, ability to fall asleep and insomnia. Women who didn’t get enough sleep or had poor-quality sleep consumed an extra 500 to 800 calories per day on average.

The results are concerning because women are at high risk for obesity and sleep disorders, both of which are associated with an increased risk of heart disease. While poor sleep has been previously associated with heart disease, this study expands limited data on the dietary connection. Scientists believe that poor sleep stimulates hunger and/or suppresses hormones that signal fullness.

Generic Drug Execs Pleads Guilty to Price Fixing

Legal Developments

On Friday, the U.S. Department of Justice announced that Hector Armando Kellum, a former senior executive with New Jersey-based generic drug manufacturer Sandoz, had pleaded guilty to conspiring with other generic drug executives to "to fix prices, rig bids, and allocate customers for generic drugs" from 2013-15. Kellum is the fourth executive charged and the third to plead guilty in the Justice Department’s ongoing investigation into generic price-fixing.

Two Sandoz drugs were involved: eczema and psoriasis drug clobetasol, and nystatin triamcinolone cream, an antifungal with a corticosteroid. Sandoz, a division of Swiss multinational pharmaceutical giant Novartis Group, is a global leader in the generics industry with annual sales topping $10 billion. Kellum is the first executive from a major generic drug manufacturer to be charged. The other three executives were from fairly small companies.

According to Reuters, sharply increasing U.S. drug prices, including drugs that have already been on the market for years, has become a political issue.

Global and Domestic Coronavirus Updates

Public Health

• Globally, more than 73,000 people are infected with the coronavirus across 27 countries, with most cases in mainland China.
• More than 1,875 people have died from coronavirus, including 5 people outside of China.
• 29 coronavirus cases are confirmed across seven states: Arizona, Illinois, California, Massachusetts, Washington, Wisconsin and Texas, the latest state to be impacted. California has eight cases while the other states have one each.
• 14 Americans from the Diamond Princess cruise ship who were quarantined for two weeks have tested positive for coronavirus.
• Total number of infected Americans: 43
• Japan trial HIV retroviral drug on coronavirus.
• Half of China’s population, about 760 million people, live in communities that have implemented regulations on residents’ ability to move about freely, although the regulations vary widely in level of restrictiveness.
• The director of Wuchang Hospital in Wuhan, Liu Zhiming, died from the virus Tuesday morning.
• About 3,000 frontline Chinese healthcare workers are infected and eight have died.