Malcolm Spicer, Managing Editor – US
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Latest From Malcolm Spicer
"You begin to see FDA telegraphing that this is important. That was lacking in the past two budgets," said Mike Greene, Council for Responsible Nutrition's chief congressional liaison. White House's budget request recommends $67m increase from FY 2019 to $1.4bn for FDA's food industry programs in CFSAN, which includes the Office of Dietary Supplement Programs, and for the Office of Regulatory Affairs' related field activities.
While Rx drug pricing is under attack by Congress, White House and consumer and public health advocacy groups, OTC drugs' value isn't gaining a higher profile. "Our health care system undervalues the contribution of our industry's products," says CHPA chief Scott Melville. Trade group conducts “Value of OTC Medicines" study for reasons including raising the profile of consumer health products in the US health care system.
USPlabs executives, others plead guilty to felony charges stemming from marketing unsafe products labeled as supplements but containing DMAA and linked to hepatitis. Blackstone Labs and other firms indicted on felony charges following FDA investigation for marketing DMBA-containing products. "It's all very welcome news, but I'm not sure this is going to change the overall environment," says Pieter Cohen, a physician who advocates for tighter regulation of supplement manufacturing and marketing.
Online retailer and supplement brand Kraken Kratom is first business American Kratom Association recognized with its GMP Qualified Vendor status. But, FDA reiterates kratom should not be used in supplements until an NDI notification is submitted showing a reasonable expectation of safety for its intended use, and DEA still has pending a proposed order to schedule kratom constituent ingredients as controlled substances.
One active ingredient in unapproved drugs sold by two e-commerce operations, identified by FDA as Rabold and AidAccess.org, is mifepristone, also known as RU-486 in the only drug with the ingredient approved for an indication of medical termination of early pregnancy, Danco Laboratories' Mifeprex. Firms' websites offer sales of products without requiring customers to submit prescriptions.
White House budget request published March 11 proposes a $643m increase in FDA's total FY 2020 funding, with $281m of the increase from FY 2019 in user fees and $362m from the agency's budget authority. Request includes OTC monograph user fees again, increased by $6m.