OverTheCounterToday

"The Tan Sheet": New Paradigm Needs Clear Switch Criteria, Standard Dispensing Rules

 

"The Tan Sheet" is your go-to source for coverage and analysis of FDA's proposed "new paradigm" for approving nonprescription pharmaceuticals under conditions of safe use. See below for a sample of our extensive coverage of the agency's recent public hearing.

Get the most in-depth reporting on the OTC pharma and nutritional industries in "The Tan Sheet." Your free trial subscription begins 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.

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 Weighs Rulemaking To Realize New Switch Paradigm

The March 26 issue of "The Tan Sheet" offers a front-row view of last week's FDA public hearing on the proposed "new paradigm" for nonprescription drug access.

We've got in-depth coverage and analysis of what agency officials think is needed to expand the possibilities for OTC switch, as well as what major industry players like GlaxoSmithKline could bring to the table.

This week's edition also looks at Procter & Gamble's "New Chapter" in consumer health products, what OTC firms should know about social media and why adolescent consumers have such a hard time obtaining emergency contraception.

For much more, and "The Tan Sheet's" March 26 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.

 

--Dan Schiff (d.schiff@elsevier.com)

"The Tan Sheet": FDA To Tackle Critical Generics Issue In Switch Paradigm Debate

 

"The Tan Sheet" is your go-to source for coverage and analysis of FDA's proposed "new paradigm" for approving nonprescription pharmaceuticals under conditions of safe use. In advance of the agency's March 22-23 public hearing, check out the below story on what innovative switches could mean for drug innovators and their generic counterparts.

Get the most in-depth reporting on the OTC pharma and nutritional industries in "The Tan Sheet." Your free trial subscription begins 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.

"The Tan Sheet": Consumers Challenge DMAA Safety After DOD Bans Products

 

This free story is brought to you by "The Tan Sheet," 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.

This Week In OTCs And Nutritionals: Generics In New Switch Paradigm, J&J's Latest OTC Delay, Possible NDI Legislation

This week's issue of "The Tan Sheet" looks at what FDA's proposed "new paradigm" for nonprescription drug access might mean for the generic versions of innovative switches, given that current law would allow equivalents to bypass voluntary access restrictions and just go completely OTC. 

Inside, we've got stories on Johnson & Johnson's struggles to return recalled OTCs to market under its consent decree with FDA and congressional supplement boosters considering legislation to bring FDA's new dietary ingredient draft guidance in line with DSHEA if the agency declines to pull back on the controversial document. There's also a feature on supplement firm ChromaDex and its pharma-like approach to product development.

For much more, and "The Tan Sheet's" full March 12 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.

 

--Dan Schiff (d.schiff@elsevier.com)

"The Tan Sheet": E-Cigarette Firm Targets Harm Reduction In Therapeutic Claim

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

“The Tan Sheet” Mar. 5, 2012, Vol. 20, No. 10

Venture capital firm Advent Life Sciences invested in U.K. startup CN Creative Ltd. to try to fundamentally change the OTC nicotine replacement therapy market with an electronic inhaler indicated for smoking cessation.

CN Creative’s promotion of harm reduction – a strategy for decreasing the number of people with diseases or other health problems linked to smoking tobacco, as opposed to strictly targeting cessation of smoking or all use of nicotine – is central to Advent’s interest, the investment firm says.

Advent led CN Creative’s first financing round, which raised $3.1 million (£2 million), the firms said Jan. 25. CN Creative will request regulatory approval for its Nicadex electronic nicotine inhaler as an NRT and already markets EVOlution e-cigarettes in Europe and the U.S. through its Intellicig business.

The timing may be right, though some experts predict that in the U.S., FDA will continue to oppose e-cigarettes and harm reduction. But legal changes have opened FDA more to considering harm reduction indications.

To continue reading this story, 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.

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

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: FDA Inspects Novartis, Pfizer Likes Consumer Fit, CHPA Quantifies OTCs' Value

The Feb. 6 issue of "The Tan Sheet" examines the recent inspection report that suggests FDA influenced Novartis Consumer Health's decisions to cease production at its Nebraska facility in December and recall OTC products in January.

As earnings season continues, we look at Pfizer's plans for its consumer health business -- which increased sales 8% in the fourth quarter -- once it divests the nutritionals and animal health segments.

Elsewhere in this week's edition, we delve into a study sponsored by the Consumer Healthcare Products Association to reveal the full economic value of OTC drugs. Additionally, we've got stories on Johnson & Johnson's latest consumer personnel changes, a follow-up on FDA's pediatric review of Plan B One-Step, and a cover story on the agency's tendency to make broad policy statements via guidance documents -- such as the new dietary ingredient notification draft.

 

This blog 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.