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.

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-- 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": Omega-3s And Depression, USP Floats Probiotics Standards, California Limits DXM Sales

This news roundup is brought to you by "The Tan Sheet," your go-to weekly source for OTC and nutritional news and analysis. For information on a free 30-day trial subscription, click here. No credit card required.

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

 

This Week In OTCs & Nutritionals: Ring In The New Year ... And The Old

The New Year starts with a bang as FDA reveals new enforcement against an ingredient banned from use in supplements and as several companies embrace new brands and strategies in an attempt to start 2012 on the right foot.

Just in time for New Year’s diet resolutions, FDA announces the seizure of products adulterated with ephedrine alkaloids – a move that sends a strong deterrence message. An agency official acknowledges other products likely contain the illegal and undeclared diet aid and that FDA will seek these as part of its enforcement against spiked supplements.

Meanwhile, ProPhase Labs’ CEO Ted Karkus discusses the firm’s plans for 2012 and beyond, including several line extensions for Cold-EEZE and new products that use the state-of-the-art delivery technology available to ProPhase through a joint venture with the Australian delivery technology firm Phosphagenics Ltd. Prestige Brands also hopes to expand its offerings in 2012 by closing the acquisition of 17 brands from GlaxoSmithKline, including BC and Goody’s brands.

Finally, we also take a look back at the most read topics of 2011, including how Johnson & Johnson handled quality control problems, the mystery of Pfizer’s consumer division’s future and the future of Rx-to-OTC switches.

Ensure you stay ahead in 2012 by making “The Tan Sheet” your go-to weekly source for OTC and nutritional news and analysis. For a free 30-day trial subscription, click here. No credit card required. Also, follow "The Tan Sheet" on Twitter and Facebook.

This Week In OTCs And Nutritionals: Perrigo Labeling Case, Pfizer Phytosterol Research, GAO Supplement AER Inquiry

Elsevier Business Intelligence launches its revamped website today! Check out the new look of "The Tan Sheet," "The Rose Sheet" and other EBI publications.  

In our Nov. 14 issue, we report on a lawsuit in federal court against Perrigo that raises the question of whether federal regulations pre-empt claims made under state laws on failure to warn. At issue is whether the private labeler should have mentioned the potential for liver toxicity on an ibuprofen product.

Inside "The Tan Sheet," we look at Pfizer's research into the cholesterol-lowering characteristics of nonesterified phytosterols, as used in the firm's Centrum Cardio multivitamin. Pfizer conducted the research to support a comment to FDA arguing that nonesterified phytosterols still should be allowed to make coronary heart disease risk reduction claims, which the agency is planning to phase out.

Additionally, we've got a pair of Capitol Hill supplement stories. Sen. Dick Durbin, D-Ill., requests a Government Accountability Office investigation into FDA's collection and analysis of serious adverse event reports linked to supplements. In the House, Rep. Dan Burton, R-Ind., offers a bill to give the supplement industry an additional 12 years -- up to Jan. 1, 2007 -- of grandfathered status for dietary ingredients on the market.

There's plenty more in this week's "Tan Sheet," including an examination of European obstacles to Rx-to-OTC switch, comments to FDA from Merck and Procter & Gamble on sunscreen regulations, and quarterly sales & earnings coverage.

 

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

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

This Week In OTCs And Nutritionals: FDA Supplement Enforcement, P&G Price Hike, Perrigo Q1

"The Tan Sheet" this week reports on FDA's supplement enforcement priorities with a dispatch from the Council for Responsible Nutrition's recent conference. FDA's Division of Dietary Supplement Programs plans enforcement activity in the areas of new dietary ingredients, good manufacturing practices and adverse event reporting. Also from the CRN conference, a story on what retailers expect to see from supplements and OTCs in the areas of social media marketing and consumer education.

Our Oct. 31 issue keeps pace with the flurry of quarterly earnings reports. In addition to news on Procter & Gamble's planned across-the-board price increase and Perrigo's underperforming OTCs and nutritionals, we've got highlights from Bayer, Colgate-Palmolive, GlaxoSmithKline, Mead Johnson Nutrition and many other reporting companies.

As always, there's plenty more in the latest "Tan Sheet," including a look at how FDA might learn from Health Canada's revised probiotics regulations, scrutiny of Allegra's allergy relief claims, and industry's defense of spray sunscreen safety.    

 

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

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

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.

This Week In OTCs And Nutritionals: The Supplement Industry Challenges Research And CHPA Workshop Features Quality Control, Switch Discussions

The supplement industry takes one on the chin, but keeps fighting after several studies spotlight the risks of supplements and suggest additional regulation may be needed. Supplement firm Herbalife also asks FDA to meet the industry half-way in the debate about what the new dietary ingredient notification process covers.

On the OTC side, FDA and drug industry leaders brainstorm best practices to improve quality control and ways to facilitate switch at the Consumer Healthcare Products Association’s Product Quality & Operations Workshop.

This news preview 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, 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.

"The Tan Sheet" News Roundup: P&G Pares Exec Ranks, Afexa Bidding War, Saw Palmetto Study

 

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.