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Malcolm Spicer

US Consumer Health Managing Editor

Washington, DC
Malcolm has expertly covered the OTC drug and nutritional supplement industries and markets since 2006. He provides authoritative and highly analytical insight into how and why the US Food and Drug Administration regulates OTC drugs, including homeopathics, and nutritional supplement manufacturing and marketing and also how companies competing in these industries can most efficiently and effectively comply with FDA regulations, the cornerstone for their success.

Latest From Malcolm Spicer

Symptoms Change But Savings OTC Drugs Deliver For US Health Care Spending Continue Growing

Substantially more consumers in 2022 report sleep issues, allergies and skin problems than in 2018 while using quit smoking aids has dropped, according to CHPA’s latest “Value of OTC Medicines” survey. Average annual household spending on OTCs is $645.

Consumer OTC Drugs

US FDA, Industry Prepare For Potential Spread Of Surging Demand For Children’s Pain Relief OTCs

FDA “understands that manufacturers expect availability to continue to increase in the near future.” CHPA is working with members “focused on safeguarding the US supply by maximizing capacity to produce and direct product to where it is needed most.”

Supply Chain OTC Drugs

US Proposed ACNU Rule Rings Bell About Rx Drugs Marketed After NDAs Eliminated With OTC Switches

Proposal for simultaneous Rx and OTC sales of same drug at same dose and indication has CHPA hoping FDA acknowledges Pataday and Voltaren Arthritis Relief are competing with Rx equivalents even though elimination of prescription NDAs was part of approvals for the two switches.

FDA Prescription To OTC Switch

Will ACNU Proposal’s Dual Rx/OTC Component Simultaneously Help And Hinder Switches?

Proposal is counter to fundamental of FDA platform for approving drugs as either Rx or OTC, with a formulation of a drug with a certain indication available in one class, not both. CHPA says the proposal also runs counter to encouraging pharma firms to invest in research needed for OTC switches.

USANA Looks Inside US, Outside Nutrition Sector For Growth Drivers, Acquiring Oolah, Rise Bar

USANA also signals its turning outside nutritional products sector for potential growth driver. One of two firms it’s acquiring, Oola Life Inc., also provides life coach services directly to customers as well as nutritional supplements.

Dietary Supplements M & A

In Comments And In Person, Pharmacist Groups Remind US FDA They'll Provide ACNU Help

Pharmacist groups’ representatives, in meeting with FDA officials, reiterate argument for greater role in access to OTCs through “additional conditions for nonprescription use.” Group not at meeting, American Society of Health-System Pharmacists, suggests “intermediate approach to nonprescription status.”

Prescription To OTC Switch FDA
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