OverTheCounterToday

This Week In OTCs And Nutritionals: FDA Hears Concerns About Allowing Novel Switches

Health care industry experts' comments to FDA show that clearing alternative routes to nonprescription status will encounter bumps and generate concerns, as you’ll read in the April 2 issue of “The Tan Sheet.”

At a public hearing on ideas about making more drugs available nonprescription but “under conditions of safe use,” stakeholders questioned whether some prescription "antidotes" should be switched to restricted nonprescription status, and noted that  drug firms likely will not invest in novel switches without market exclusivity and a requirement to make generics also subject to consumer access restrictions. 

In this issue we also report on the Health Choices Coalition urging Congress to support legislation that would strike the health care reform law requirement that consumers obtain a prescription in order to purchase OTCs with a pre-tax savings account.

For much more, and "The Tan Sheet's" April 2 table of contents, click here.

"The Tan Sheet" is your source for the most comprehensive and in-depth coverage of the OTC drug and nutritional industries. Start your free trial subscription here -- no credit card required.Your company or organization may already provide access to "The Tan Sheet." To find out if you should have access, email custcare@elsevier.com.

Also, follow "The Tan Sheet" on Twitter and Facebook.

-- Malcolm Spicer (m.spicer@elsevier.com)

 

 

This Week In OTCs And Nutritionals: FDA Considers “New Paradigm” To Switch More Rx Drugs

We added to our web site a breaking news alert that FDA is considering a “new paradigm” for approving new drugs to facilitate making more Rx products available nonprescription, according to a notice for a March 22-23 public hearing.

Our Feb. 27 issue offers in-depth analysis of Prestige Brands Holdings’ response to Genomme Labs’ unsolicited acquisition offer. “The Tan Sheet” also explains why some firms are using the GRAS affirmation process instead of submitting supplement NDI notifications, and why Rx-only requirements might not be the solution to prevent purchases of pseudoephedrine drugs to make methamphetamine.

Click here for a full table of contents from our Feb. 27 issue.

 "The Tan Sheet" is your source for the most comprehensive and in-depth coverage of the OTC drug and nutritional industries. Start your free trial subscription here -- no credit card required.

Also, follow "The Tan Sheet" on Twitter and Facebook.

– Malcolm Spicer (m.spicer@elsevier.com)

 

OTC/Nutritional News From "The Tan Sheet": Advocates Refile Plan B Lawsuit; Plan B Available in University Vending Machine; Korea’s Wider OTC Access Stalls

This Week In OTCs And Nutritionals: Switch, GMPs, Abbott

The Oct. 24 issue of “The Tan Sheet” reports on researchers’ recommendations for sponsors of OTC switch applications based on questions FDA has asked in previous switches, as well as additional news in the OTC sector from firms including Johnson & Johnson and Help Remedies.

We also note that for the first time, FDA submitted GMP warning letters with language explaining the agency considers own-label dietary supplement marketers responsible for their contract manufacturers’ violations. Plus, we look at how Abbott Laboratories’ nutrition business gains importance with the firm’s plan to spin off its research-based branded pharmaceuticals business.

Make "The Tan Sheet" your go-to weekly source for OTC and nutritional news and analysis. For information on a 30-day free trial subscription, click here.

Also, follow "The Tan Sheet" on Twitter and Facebook.

"The Tan Sheet" News Roundup: J&J Tops Forbes Brand Rankings, Studies Question Supplements, Pryor Re-tries Nanotech Bill

This news roundup is brought to you by "The Tan Sheet," your source for the most in-depth news and analysis from the world of OTC drugs and nutritionals. For information on a 30-day free trial subscription, click here.

Also, check out "The Tan Sheet" on Twitter and Facebook.

This Week In OTCs And Nutritionals: Tough-Pill-To-Swallow Edition

As the dietary supplement industry continues digesting FDA’s expectations that significantly more new dietary ingredients notifications are necessary, the agency also dishes out some news on serious adverse event reports that the industry could find hard to swallow, this week’s issue of “The Tan Sheet” reports.

FDA’s Division of Dietary Supplement Programs suggests that supplement firms should be submitting to the agency more of the reports on adverse events the firms are receiving from consumers and other parties. Meanwhile, industry champion Sen. Orrin Hatch makes clear he agrees with stakeholders that FDA’s draft guidance on NDI notifications oversteps regulations established by DSHEA.

In this issue, we also report on an attorney’s caution about functional food advertising claims due partly to increased enforcement in the area.

[“The Tan Sheet” is your weekly full-course meal with ingredients from throughout the OTC drug and nutritional product industries. Sign up here for a free 30-day trial subscription.]

This Week In OTCs And Nutritionals: Class In Session Edition

 
“The Tan Sheet” this week reports on a GlaxoSmithKline-backed study that shows educating consumers about the safety and efficacy of nicotine-replacement therapies could lower their concerns about the products’ prices.

We also report that Pfizer would need to learn a lot about consumers’ safe self selection if the firm wants to switch its high cholesterol treatment Lipitor to OTC, and dietary supplement industry trade groups want to learn more about how FDA will calculate the user fees authorized by the Food Safety Modernization Act.

[Move to the head of the class in the OTC pharma and nutritional industries with "The Tan Sheet." Start a free 30-day trial subscription by clicking here.]

Education About NRT Safety Overcomes Smokers’ Cost Barrier – Study
Drug firms could educate consumers about the safety and efficacy of nicotine-replacement therapies to show the products’ value, according to recent research.

Lipitor OTC Switch Would Force Pfizer To Clear Big Research Hurdles
Pfizer would face major hurdles in research on consumers’ safe self-selection for FDA to approve an OTC switch of the firm’s cholesterol treatment Lipitor.

Supplement Industry Questions FDA's Calculations For Food Safety User Fees
Good manufacturing practice compliance becomes more critical for dietary supplement firms as FDA sets the first user fees to cover agency costs for follow-up inspections of facilities and imports and work on mandatory recalls.

This Week In OTCs And Nutritionals: NDI Guidance Could Be Summer Blockbuster

Just when the supplement industry thought it was safe to go back in the new dietary ingredient water, FDA's top supplement official says more enforcement activity is likely once the NDI notification guidance hits theaters -- er, dockets -- as is expected next week.

But will the guidance prove a smashing success with the industry that has waited years for it? Or will it bomb? This week's issue of "The Tan Sheet" has the story.

Our June 27 edition also shines a light on what FDA thinks about spray sunscreens and checks in with several ingredient companies making moves in the functional foods arena.

 

["The Tan Sheet" is rated "E" for essential market insight covering the OTC pharma and nutritional industries. Snap up a free 30-day trial subscription here.]

 

TOP STORIES

Low NDI Notice Compliance Sets Stage For Enforcement – FDA’s Fabricant
The volume of noncompliant supplement ingredients on the market likely will prompt an uptick in enforcement after FDA releases its NDI notification guidance, which will draw attention to the problem, dietary supplement program chief Daniel Fabricant says.

FDA Questions Spray Sunscreen Safety, Efficacy And Monograph Status
FDA could exclude increasingly popular spray sunscreens from the final monograph unless firms submit sufficient safety and efficacy data, according to an advanced notice of proposed rulemaking.

Ingredient Supplier Interest In Functional Foods Shows No Sign Of Let-Up
Market research firm Mintel says the consumer market for functional foods and beverages has hit a lull, but at the product development level the segment continues expanding with new ingredients and applications.  

Times Reviews Hatch's Star Turn In Supplement Industry Support

 
The New York Times questions whether Sen. Orrin Hatch’s advocacy has hindered FDA from preventing dangerous products from reaching the market.

OTC/Nutritional News Roundup: New Wrinkles Edition

 
Firms develop wrinkle and pimple creams as more adults seeks treatment for acne…Gerber adds a new wrinkle to the infant formula market with the first qualified health claim… South Korea health agency opposes regulatory wrinkle allowing wider access to OTC drugs…

[Keep up with all the new wrinkles in the OTC and nutritionals industries, including the latest products for preventing wrinkles, in "The Tan Sheet." Click here for a free trial.]