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A US meeting of experts to discuss testing for OTC antiseptic topicals that help prevent the spread of diseases as well as conferences for an industry that relies on increasing regard by consumers for self-care as a key growth driver have been postponed or cancelled due to the coronavirus.

In addition to announcing that its Nonprescription Drug Advisory Committee meeting on food handler antiseptic drug products scheduled for 11 March is postponed, the US Food and Drug Administration said it is suspending most inspections of manufacturing facilities in foreign countries through April due to the Covid-19 outbreak.

CDC Tracks Outbreak

The US Centers for Disease Control and Prevention reported that through 4 p.m. EDT on 10 March:

  • Total US Covid-19 cases: 647;
  • Total deaths: 25;
  • Jurisdictions reporting cases: 36, including Washington, DC.

     

The latest consumer health industry conferences to be cancelled or postponed due to Covid-19 are Consumer Healthcare Product Association and Informa Markets events. CHPA’s executive conference scheduled for 22-24 March in Orlando, FL, is cancelled, the trade group said on 10 March.

“These are indeed challenging times for our country and the global community as we collectively struggle to address the impact” of the Covid-19 outbreak, said CHPA president and CEO Scott Melville in a statement sent to people who had registered to attend the conference.

Melville said the association is determining whether the planned content for the conference could be shared later in the year. All other CHPA 2020 meetings are proceeding as planned, subject to change as events require.

The SupplySide East food and supplement industry trade show in Secaucus, NJ, conducted by a separate division of HBW Insight’s parent firm, Informa Inc., has been postponed from 20-22 April until 23-24 June. Informa Markets on 9 March said its SupplySide West and Food ingredients North America 2020 show remains scheduled for 26-30 October in Las Vegas.

“This is an unprecedented time for our industry, and our focus will continue to be on what is best for our industry partners,” said Jon Benninger, SupplySide’s vice president and market leader. “This is new territory for all of us,” Benninger added.

Energy And Commerce Wants Covid-19 Impact Update

A day before the FDA's statement about its foreign inspection plans in response to Covid-19, on House Energy and Commerce Committee members are asking the agency for a comprehensive assessment of the outbreak's potential impact on US drug industry supply chains and on its impact on the agency's inspections.

A letter submitted on 9 March requested a briefing on the potential impact on the supply of drugs and other medical products in the US. It was signed by Chairman Frank Pallone, D-NJ, ranking member Greg Walden, R-OR, Health Subcommittee Chairwoman Anna Eshoo, D-CA, and ranking member Michael Burgess, R-TX, and Oversight and Investigations Subcommittee Chairwoman Diana DeGette, D-CO and ranking member Brett Guthrie, R-KY.

They "would like to know how many manufacturers, distributors, and importers might be affected by supply chain issues,""are "interested in FDA's ongoing work to combat shortages, including what the Agency is hearing from potentially affected" industries it regulates and "what steps it is currently considering or taking to reduce potential shortages."

Additionally, the committee's leadership wants an updated on Covid-19's resources. "To ensure the agency remains responsive and prepared, we would like to know more about FDA's resources, specifically, how existing resources are being used to account for this new challenge, how this will affect other vital operations at FDA, and whether the agency will need additional resources to meet supply chain demand."

The American College of Physicians also has cancelled its Internal Medicine Meeting 2020, scheduled for 23-25 April in Los Angeles, referencing reports from the World Health Organization and the CDC “of rapidly escalating concerns about” Covid-10. The ACP also noted in a 10 March release because “of the vital role of internal medicine physicians in diagnosing, managing and caring for their patients and communities on the front lines,” it decided “the only responsible choice was to cancel” the meeting.

A separate consumer health industry trade show conducted in Anaheim, CA, by an Informa business, New Hope Network’s Natural Products Expo West, also has been postponed due to Covid-19. New Hope on 3 March said the event scheduled that week could be re-scheduled by mid-April, either in Anaheim or elsewhere. (Also see "HBW Market Roundup: Expo West Postponed, FDA Needs International Cosmetics Meeting Input, More" - HBW Insight, 3 Mar, 2020.)

Food-Handler Antiseptic Discussion Must Wait

The FDA’s announcement cancelling the NDAC meeting planned at the agency's headquarters campus in Silver Spring, MD, to review information on use of the antiseptic products in food-handler settings came the day before the deadline, 10 March, for comments to the docket – FDA-2020-N-0418. (Also see "FDA Wants Fast Approval For Cosmetic, Supplement Perceptions Survey" - HBW Insight, 10 Feb, 2020.)

The agency didn’t estimate a second date for the event, but said the meeting “is being postponed until further notice.

A review of OTC antiseptics' use in food-handler settings would follow the agency's reviews of the products' use in health care settings and by consumers. In April 2019, it released a final rule for consumer antiseptic rubs, products intended for use when soap and water are unavailable, stating that 28 active ingredients are not generally regarded as safe and effective for inclusion as OTC monograph ingredients and that it will consider additional information on three others – benzalkonium chloride, ethyl alcohol, and isopropyl alcohol. (Also see "FDA’s Final Rule On OTC Antiseptic Rubs Affects Just 3% Of Market; Alcohol Rulemaking Deferred" - HBW Insight, 11 Apr, 2019.)

A separate final rule effective in December 2018 removed 24 ingredients from monograph approval for use in formulations for health care personnel hand washes and rubs, surgical hand scrubs and rubs and patient antiseptic skin preparations and allowed six – povidone-iodine, isopropyl alcohol, benzalkonium chloride, benzalkonium chloride, benzethonium chloride and chloroxylenol – to remain available while facing potential exclusion. (Also see "More GRASE Time For 6 OTC Antiseptic Ingredients But 24 Flushed In Final Rule" - HBW Insight, 19 Feb, 2018.)

"To maintain oversight over international manufacturers and imported products” while inspections are stalled, FDA other continues methods to prevent unsafe consumer health products from reaching the US, including methods familiar to the US food and dietary supplement product industries: denying entry of unsafe products into the US and physical examinations and/or product sampling at US borders.

The FDA also is cancelling or postponing other advisory committee meetings or other events it had planned this month in Washington or the surrounding suburbs. (Also see "As Coronavirus Tightens Its Grip, US FDA Cancels Some Meetings Due To ‘Extenuating Circumstances’" - Pink Sheet, 9 Mar, 2020.)

State Department: No Government Travel

In a 10 March statement, the FDA said it based its decision on suspending foreign inspection on a factors that include a Department of State advisory prohibiting travel for US government employees.

The agency also considered Control and Prevention travel recommendations; Office of Personnel Management guidance; access restrictions imposed on foreign visitors by certain countries; and the importance of the health and safety of its employees.

However, “to maintain oversight over international manufacturers and imported products,” the agency continues other tools and methods, said Commissioner Stephen Hahn.

Those include methods that are familiar to the US food and dietary supplement product industries: denying entry of unsafe products into the US and physical examinations and/or product sampling at US borders. (Also see "Hemorrhoid, Lice Treatments Join Usual Suspects On FDA Import Alerts" - HBW Insight, 19 Jun, 2017.)

Hahn also noted methods of reviewing a firm’s previous compliance history and using information sharing from other governments as part of mutual recognition and confidentiality agreements.

He said another tool is one the agency began using when it postponed on-the-ground inspections of manufacturers of FDA-regulated products in China earlier in the outbreak is requesting records “in advance of or in lieu of” on-site drug inspections.

“We will be vigilant and monitor the situation very closely and will try to mitigate potential impacts from this outbreak in lockstep with the whole of the federal government. We stand ready to resume foreign inspections as soon as feasible,” the commissioner said in the agency’s statement.

Consumer health industry executives as well as FDA officials previously acknowledged that Covid-19 impacts could include disrupting supply chains, while stakeholders also say their earnings will be affected. (Also see "Coronavirus Drives TCM Sales In China, Clouds Global Consumer Health Outlook" - HBW Insight, 20 Feb, 2020.)

However, recent Nielsen Co. LLC research showed that consumers' Covid-19 concerns are spiking sales of essentials. In the US, for example, sales of supplements, fruit snacks and first aid kits are all on the rise. (Also see "Coronavirus Disruption Likely In Supply Chain, Stockpiling Spikes Consumer Health Sales" - HBW Insight, 6 Mar, 2020.)

 

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