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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

Homeopathics, Supplements, OTC Medicines Overlap In Pharmacists’ ‘Over-The-Counter’ Survey

Results of U.S. News & World Report’s first “Best OTC Medicine & Health Products” survey include homeopathic formulations, supplements and non-drug topicals in same categories of indications with nonprescription pharmaceuticals.

Consumer Market Intelligence

NMN Supplement Firm Works On Disclosing Sales Relationships With Advertising Affiliates

Renue By Science agrees with National Advertising Division recommendations to “clearly and conspicuously disclose” material connections in online advertising by employees, nonprofits and others offering sales to its supplements containing nicotinamide mononucleotide, quercetin or resveratrol.

Dietary Supplements Ad Complaints

Pending Decision On First US OTC Birth Control Shines Spotlight On Self-Report Study Data

Approval likely would account for all weight on scale of FDA decision if not for self-report element in design of HRA Pharma’s actual use study for OTC switch of 0.075-mg norgestrel branded Opill. HRA’s sNDA offers lesson for using electronic diary apps in self-report studies.

FDA Prescription To OTC Switch

House Appropriations Subcommittee Proposes FDA FY2024 Budget $662M Short Of Request

Appropriations Agriculture, Rural Development, FDA and Related Agencies Subcommittee marked up its FY2024 bill on 18 May, proposing $6.579bn for FDA. Total is up from current budget of $6.562bn, but Biden administration proposed $7.2bn for FY2024.

FDA Consumer

Salonpas Samples Its History To Attach US, Canadian Consumers To Topical Analgesics

"Our eyes are more on Advil, Tylenol. We want to be considered first-line treatment for pain, for pain appropriate for what our products are," says Hisamitsu America CEO John Incledon.

Ad Campaigns OTC Drugs

Over The Counter 22 May 2023: What You Need To Know About HRA’s Historic US OTC Pill Switch With HBW’s Malcolm Spicer

HBW Insight catches up with US executive editor, Malcolm Spicer, to discuss Perrigo subsidiary HRA Pharma’s Rx-to-OTC switch application for its daily contraceptive, Opill. With the switch currently under consideration by the US Food and Drug Administration after a positive recommendation from its advisory committees, Spicer draws on his in depth coverage of the subject, as well as his extensive experience writing about the US consumer health market, to tell listeners what they need to know about this historic switch.

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