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: 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decree with FDA and congressional supplement boosters considering legislation to bring FDA's new dietary ingredient draft guidance in line with DSHEA if the agency declines to pull back on the controversial document.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)

This Week In OTCs And Nutritionals: OTC Anthrax MedKit, E-Cigarette Harm Reduction, FTC Vs. Garden Of Life

In addition to in-depth coverage of FDA's notice of a public hearing to consider a "new paradigm" for OTC pharmaceutical access, this week's issue of "The Tan Sheet" features stories on an upcoming FDA advisory committee meeting to discuss OTC home-use anthrax MedKits and an electronic cigarette company that aims to make harm-reduction/nicotine-replacement therapy claims.

"The Tan Sheet" also looks at a federal court's ruling that went in favor of supplement firm Garden of Life and against the Federal Trade Commission. We've got updates on Abbott, Colgate-Palmolive and Procter & Gamble, too.

For much more, and "The Tan Sheet's" full March 5 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.

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

 

- Dan Schiff (d.schiff@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: Plan B Pediatric Analysis, Class Action Claims, Supplement Industry Year Ahead

This week, "The Tan Sheet" examines FDA's review of Teva Pharmaceutical Industries' Plan B One-Step levonorgestrel product, and its determination that the emergency contraceptive does not raise pediatric safety concerns. The agency's Pediatric Advisory Committee is meeting this week to discuss Plan B and other drugs.

Our Jan. 30 issue also features coverage of the Food and Drug Law Institute's Food Week, including a discussion of what makes functional food and supplement companies vulnerable to class action lawsuits.

"The Tan Sheet" additionally checks in with supplement industry leaders on what to expect in 2012, and looks back at 2011 via the full-year financial results from Johnson & Johnson, Novartis, Procter & Gamble, and more.

 

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.

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: Beyond A Shadow Of A Doubt Edition

FDA advisory committees May 18 made clear their preferences on each question the agency posed on dosing directions and labeling for pediatric single-ingredient 
acetaminophen products and on whether a single concentration is needed for solid oral dosage forms. 

“The Tan Sheet” this week makes clear the advisory panel members’ concerns about the safety of children’s acetaminophen products. This issue also leaves no question that industry stands behind the products' safety.

Additionally, we report the development of OTC drugs based on probiotics might require a regulatory system more receptive to research on the microorganisms' use as therapeutic ingredients, and on Procter & Gamble and Colgate-Palmolive touting the growing strength of their branded products over generics.

(Eliminate any doubt about being on top of the OTC drug and nutritional product markets by reading “The Tan Sheet” every week. Click here for a free 30-day trial.)

FDA Advisory Panel Backs One Concentration For Kids' Solid-Dose Acetaminophen

The votes are in, and a joint advisory panel says FDA should consider requiring that OTC manufacturers produce a single concentration of acetaminophen in solid-dose, single-ingredient pediatric products.

Manufacturers recently said they would voluntarily standardize the concentration for liquid acetaminophen products for kids, but did not support a similar move for solid formulations. Regardless, the Pediatric and Nonprescription Drugs advisory committees voted 17 to 3 on this point.

Also at the joint meeting May 17-18, the advisory panels said industry should expand dosing information for all single-ingredient pediatric acetaminophen OTCs to include children as young as 6 months, and voted unanimously that FDA require weight-based dosing information on acetaminophen drug labels.

The May 19 edition of "Health News Daily" will have more on what went down in Silver Spring, and make sure to catch up with "The Tan Sheet" on May 23 for additional perspective and analysis.

For now, continue reading for the full advisory committee meeting preview story from our May 16 issue.

 

[When NDAC comes together, you can be sure "The Tan Sheet" will be there. Check out our in-depth OTC pharmaceutical and nutritional coverage with a risk-free 30-day trial. Click here for more info.]

This Week In OTCs And Nutritionals: Back To The Future Of OTC Drugs

 
This week's issue of "The Tan Sheet" looks at a number of potential turning points and future implications for OTC drugs. Our cover story goes inside Acura Pharmaceuticals' "extraction-resistant" pseudoephedrine, which the firm believes could transform the category of decongestants fueling the methamphetamine controversy in many states.

Our May 16 edition previews the May 17-18 FDA advisory committee meeting, at which the Pediatric and Nonprescription Drugs panels will mull the future of dosing, labeling and packaging for children's acetaminophen products. We'll have more coverage of the meeting this week in "Health News Daily" and in our May 23 issue.

Additionally, "The Tan Sheet" visits with members of the Health Choices Coalition, which seeks to repeal the provision of health care reform limiting coverage of OTC drug purchases under tax-exempt accounts. Future health care costs could grow if consumers have less incentive to buy OTCs, coalition members warn.

Finally, we look at what diagnostic technology and personalized medicine could mean for the future of nonprescription drug development and Rx-to-OTC switches. It will take some ingenuity on the part of industry to make that future a present reality.

 

["The Tan Sheet" sees in-depth OTC news and analysis in your future. Click here to sign up for a free 30-day trial.]  

This Week In OTCs And Nutritionals: Table Of Contents

 
While "The Tan Sheet" eagerly awaits next week's FDA advisory committee meeting to discuss pediatric dosing of acetaminophen, the OTC industry announced last week it plans to voluntarily move to a standardized concentration of acetaminophen in single-ingredient products for all children up to age 12.

But our May 9 issue has plenty of non-acetaminophen stories, too. We've got exclusive coverage of last week's SupplySide East conference and trade show in Secaucus, N.J., where supplement industry stakeholders examined the food safety law's impact on ingredient suppliers and FDA supplement official Brad Williams said agency inspectors are finding "pretty dismal" compliance with good manufacturing practices.

Additionally, with earnings season in full bloom, "The Tan Sheet" looks at Perrigo's streak of record revenues and profits, and Pfizer's gradually unfolding restructuring plans, which may include consumer business divestments.

 

["The Tan Sheet" will be your source for news and analysis from the May 17-18 FDA advisory committee meeting on acetaminophen, as well as everything else happening in the world of OTC drugs and nutritionals. For information on a risk-free 30-day trial subscription, click here.]

 

TOP STORIES

OTC Industry Standardizes Pediatric Liquid Acetaminophen Concentration
Over-the-counter drug firms will make single-ingredient liquid acetaminophen pediatric products only in one standard concentration to help prevent dosing errors, their trade association said May 4.

Supplement Ingredient Suppliers Should Prepare For Food HACCP Regs
The exemption Congress gave dietary supplement manufacturers from the hazard analysis and critical control points regulations for food products does not extend to ingredient suppliers, experts say.

Perrigo Rogaine Foam ANDA May Help Extend Record Growth
Perrigo's regulatory green light to market the first OTC generic of Men's Rogaine Foam further extends the pipeline that has kept the firm on a streak of record earnings.