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Malcolm Spicer

Malcolm Spicer, Managing Editor – US

Washington, DC
Malcolm Spicer is lead analyst for Pharma intelligence | informa's coverage of the consumer health care products industries. He provides comprehensive and insightful reporting on manufacturing, marketing, regulation, legislation, financial and research news about the nonprescription drug and nutritional product industries. He has worked in this post for 10 years and previously reported for other publications on regulation of the health care industry, on the telecommunications and internet technologies and on the US energy market.

Latest From Malcolm Spicer

Proposed OTC Switch Rule Anticipates Digital World

FDA’s “Additional Condition for Nonprescription Use” proposal is all about information which won’t be printed on DFLs but will be integral to whether some switch proposals’ approval. But agency doesn’t explicitly exclude switch sponsors from assigning delivery of ACNU information to staff in stores or in online chats.

Prescription To OTC Switch Retail

Since 2012, No Shortage Of Variety In US OTC Switches While Short Of Chronic Conditions

From intranasal corticosteroids to a lice treatment, and from an addition to the OTC PPI market to the first nonprescription acne drug reaching the market through an NDA, US OTC switches in the past 10 years, since FDA began considering widening switch opportunities, haven’t lacked for variety.

FDA Prescription To OTC Switch

Dual Rx/OTC Status In US ‘Additional Condition’ Switch Proposal: Necessary Or Questionable?

OTC drug development and marketing consultants discuss FDA allowing simultaneous Rx and OTC sales of same drug formulation with the same indication and about opportunities for follow-on generic equivalents of switches approved as additional condition for nonprescription use OTCs.

FDA Policy

Expanding US OTC Switches Turns On Flexibility In FDA Drug Approval Process

The “Nonprescription Drug Product with an Additional Condition” for OTC use proposed rule would add to drug firms’ workloads for some OTC switches. Along with NDAs, sponsors would need to show a DFL isn’t sufficient to ensure a consumer can appropriately self-select and use a drug OTC and how an “additional condition” system would work.

Prescription To OTC Switch Drug Approval Standards

Proposed Rule Making More OTC Switches Likely In US Makes More Tools Necessary For Sponsors

OTC drug development and marketing consultants spoke with HBW Insight about FDA’s “Nonprescription Drug Product with an Additional Condition for Nonprescription Use” proposed rule. In first of two articles, they discuss proposed rule’s likely impacts on industry and remaining concerns around incorporating extra-label information in drug labeling.

FDA Prescription To OTC Switch

Expanding US OTC Switches Turns On Flexibility In FDA Drug Approval Process And For Consumers

“Nonprescription Drug Product with an Additional Condition” for OTC use proposed rule would add to drug firms’ workloads for some OTC switches. Along with NDAs, sponsors would need to show a DFl isn’t sufficient to ensure a consumer can appropriately self-select and use a drug OTC and how an “additional condition” system would work.

FDA Prescription To OTC Switch
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