Hand Sanitizer Efficacy And Safety Data Gaps Concern FDA
The Food and Drug Administration wants more information about repeated exposure and use by children and pregnant women, but the agency made clear it is not saying the product is harmful yet. It is just seeking information about ingredients.
The Washington Post:
FDA Raises Questions About ‘Data Gaps’ Regarding Safety, Effectiveness Of Hand Sanitizer
The colorful gels have become the front lines in our fight against germs. Antiseptic hand sanitizers in greens, blues and reds are now ubiquitous in schools, workplaces and hospitals. They are must-haves in moms' pocketbooks. And they have been distributed in West Africa to fight Ebola and in South Korea against Middle East Respiratory Syndrome. Although these products were designed to be used when old-fashioned soap and water aren't available, many people use them multiple times a day even when a sink is nearby under the belief that they are killing more bacteria. (Cha, 6/29)
The Associated Press:
FDA Has A Few Questions For Makers Of Hand Sanitizer
Federal health officials want to know whether hand sanitizers used by millions of Americans work as well as manufacturers claim — and whether there are any health risks to their growing use. The Food and Drug Administration is asking for new studies on how the antiseptic gels and rubs fight germs and get absorbed into the body, with a particular focus on children and pregnant women. The proposal unveiled Wednesday is part of an ongoing government effort to review decades-old chemicals that have never had a comprehensive federal review. (6/29)
The Wall Street Journal:
FDA Seeks Proof Of Safety, Effectiveness Of Hand-Sanitizing Products
The FDA said it was particularly interested in accumulating evidence concerning the safety of long-term, repeated exposure, especially in pregnant women and children. “The idea of the rule is to fill in data gaps, particularly with safety,” said Janet Woodcock, director of the FDA Center for Drug Evaluation and Research. “We don’t know how much they’re absorbed into the body in maximum use.” Dr. Woodcock noted that such products used to be primarily at events such as lobster dinners, but are today omnipresent in sites such as elevator lobbies. (Burton, 6/29)
In other news from the FDA —
Politico Pro:
New FDA Cancer Chief Seeks Both Speed And Quality For New Drugs
Speed versus quality. They're often talked about in health policy as two opposing concepts but FDA’s new Oncology Center of Excellence leader Richard Pazdur believes the agency can speed cancer drugs to patients while maintaining its commitment to quality and safety. What truly speeds drugs to patients? The answer, according to Pazdur, who has led FDA’s review of new cancer drugs for more than a decade, is not science. It's about management. (Karlin-Smith, 6/29)
Austin Statesman:
Don't Ever Eat Raw Cookie Dough, FDA Warns
If you just can't resist eating the last bits of raw cookie dough from the bowl while baking, the U.S. Food and Drug Administration has a message for you: don't. The FDA warned Tuesday against eating raw dough amid an E. coli outbreak that has caused 38 illnesses in 20 states. The outbreak started in December 2015. The Centers for Disease Control and Prevention determined at least half of those who fell ill made something at home with flour. Subsequent tests linked the outbreak with General Mills flour produced in Missouri, and the company issued a voluntary recall of 10 million pounds of flour. (Cox Media Group, 6/30)
