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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.
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Latest From Malcolm Spicer

FDA's OTC Naloxone Model Labels Confirmed In CONFER Study

Participants in FDA-commissioned CONFER study were scored on following label instructions for checking whether a potential patient has overdosed and administering a naloxone dose before calling for emergency help as well as on a "composite of cognitive walkthrough" of all those steps. Participants were in four groups: adult users of heroin and prescription opioids; those persons' friends and family members 18 years old and up; and separate groups of volunteers, 15- to 17-year-olds and adults.

Prescription To Otc Switch OTC Drugs

FDA Has Model Drug Facts Labels For OTC Naloxone, Wants Switch Proposals

Development of the model DFLs was a first for agency, reflecting alarm over public health crisis of overdoses from opioid abuse, which reached nearly 48,000 in 2017. The project was "part of our broader commitment to addressing the opioid crisis" and should help sponsors with potential naloxone OTC switch NDAs, says Commissioner Scott Gottlieb.

Prescription To Otc Switch Regulation

Perrigo Expanding Consumer Portfolio After Finding Problems Slowing Growth

"Probably the worst offense" among Perrigo's problems is that before appointing President and CEO Murray Kessler in November, it had three CEOs since 2016, making him the fourth chief executive in three years, says Kessler. Perrigo's move to a self-care focus means "a broader emphasis on the wellness component of health and wellness" and opening its portfolio of products and categories to areas including nutraceuticals, oral care, probiotics, therapeutic skin care products and others.

Commercial OTC Drugs

Irish $1.9bn Tax Bill 'Out Of Nowhere' Perplexes Perrigo, Troubles Analysts

Perrigo appeals tax assessment Ireland levied in late December on Rx ingredient royalty rights firm gained when it became incorporated in Dublin but no longer owns, Analysts allowed President and CEO Murray Kessler. benefit of doubt he'll lead Perrigo out of prolonged slump when he joined firm in November after extensive executive experience with tobacco firms and in other consumer goods markets, but they're more circumspect about its chances of prevailing in Irish tax disagreement.

Commercial Policy & Regulation

House Maintains Momentum For OTC Monograph Reform, Senate Regard TBD

House passes, with large bipartisan support, Pandemic and All-Hazards Preparedness and Advancing Innovation Act, which includes Over-the-Counter Monograph Safety, Innovation, and Reform Act for modernizing FDA's system overseeing vast majority of OTC drugs. Provisions would allow FDA to use administrative orders, rather than notice-and-comment rulemakings, to add ingredients, dosages, delivery formats or indications to monographs, or drugs marketed without approved applications.

Legislation Consumer

Herbalife Shakes Up Executive Suite Due To CEO's Earlier Statements On Expenses

Herbalife announced following close of trading on US exchanges that former CEO and current Chairman Michael Johnson returns as interim chief following Richard Goudis' resignation.The firm, which has yet to schedule the release of its 2018 fourth-quarter results, said Goudis’ exit "pertains to comments which recently came to light" he made prior to becoming CEO in 2017.

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