Manufacturing

Stada will ship a wide range of consumer healthcare products from its new Romanian production facility, into which the German firm has invested over €70m.

Although FDA concluded OTC oral phenylephrine is ineffective as a nasal decongestant in doses up to highest studied level, federal preemption precludes challenges to agency’s regulation of labeling for phenylephrine and other Rx and OTC drugs, according to recent decision in New York federal court.

FDA tobacco programs chief emphasizes moving smokers to lower risk alternatives and NIDA executive encourages proposals for e-cigarettes as nicotine replacement treatments. FDA also seizes $76m in unauthorized e-cigarettes.

Requests for “enforcement actions are not within the scope of FDA’s citizen petition procedures,” CDER says, rejecting petition dosing device firm Parenteral Technologies submitted as it prepares for workshop on Pediatric Research Equity Act requirements for OTC NDA sponsors.

UK pharma also reaches agreement in principle, subject to DoJ approval, to pay $70m to resolve a whistleblower complaint filed by Valisure, the testing lab which in 2019 raised concerns about a potential link between the use of drugs containing ranitidine, a histamine-2 blocker, and cancer.

NDAs for additional OTC products containing acetaminophen and/or NSAIDs and indicated for use by children between 2 and less than 12 years old would trigger compliance by application sponsors with the act passed in 2003 to address lack of pediatric use information in drug labeling.

Regenerative Processing replaces nozzle to prevent backflow for its Regener-Eyes drops but FDA warning states numerous questions about sterility at the firm’s plant and about its procedures and systems for preventing microbial contamination.

After launching Retaine MGD Advanced, OcuSoft says a release by Bruder Healthcare referenced Retaine MGD trademark and statements from a previous OcuSoft announcement about the original product attributed to an optometrist. B+L, Rohto brand and homeopathic firm Relief Products also make US OTC eye care space moves.

Jessica Spence joins as North American president while CFO Dan Sullivan becomes COO and Francesca Weissman, finance and business strategy SVP, adds CFO to her title in latest executive office changes by the marketer of brands including Schick men's and women’s shaving, Playtex, Stayfree, Carefree and o.b. feminine care and Banana Boat and Hawaiian Tropic sun care.

Streamlined process for reporting problems is key piece of “unified Human Foods Program” which officially launched on 1 October, as Commissioner Robert Califf says, “a new model for field operations and other modernization efforts.”

Nonbinding forecast, fourth for the program, includes risks associated with codeine-containing cough medicine as a topic FDA will include in ongoing evaluation of GRASE for pediatric cough cold drug products marketed under monograph for cold, cough, allergy, bronchodilator and anti-asthmatic OTC drugs.

Mucinex Sinus saline nasal spray is designed to treat sinus-related symptoms as “first-ever drug-free saline product” with a dual nozzle offering two spray settings, marketer Reckitt-Benckiser says.

Following Energy and Commerce Health Subcommittee hearing about FDA’s human food and tobacco programs on 10 September, gap between what the trade groups, committee leadership and the FDA each want more of doesn’t appear to be shrinking.

In addition to commentary and information about the OTC drug, dietary supplement and cosmetic industries, speakers offered candid remarks on subjects well known across the consumer health industry or well recognized by consumers.

Reorganization creating in Human Foods Program makes the work of additional staff available for dietary supplement office programs. FDA’s “got a little tiny workforce” for “a huge industry,” says Commissioner Robert Califf.

“It's really the elected officials who are making the final determination on what happens. They're really the owners of the teams, you guys in the industry are playing the game we’re refereeing,” FDA Commissioner Robert Califf says at Consumer Healthcare Products Association conference.

In this episode of HBW Insight's Over The Counter podcast, we connect with Neil D’Souza, CEO of Makersite GmbH, a data software company based in Stuttgart, Germany that offers “next generation” product data management tools that help personal care and other industries manage product sustainability, cost and compliance.

Agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.

The revised EU Urban Wastewater Treatment Directive, which obliges pharmaceutical and cosmetic industries to contribute at least 80% towards the costs of removing micropollutants from wastewater through quaternary treatments, will place an additional burden of around €2bn per year on German manufacturers, says Pharma Deutschland. 

“Control of Nitrosamine Impurities in Human Drugs” guidance, FDA’s third on the subject, adds nearly 20 pages to 2021 guidance document it revises with more extensive discussions of each topic included in the earlier guidance.