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.

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

 

 

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.

 

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This Week In OTCs And Nutritionals: A Cold Front Chills Industry

The temperatures outside are dropping, but Jack Frost is not responsible for the cooling relationship between FDA and the dietary supplement industry. Trade groups respond icily to new dietary ingredient notification draft guidance that they say contravenes the Dietary Supplement Health and Education Act. Most groups agree FDA should rewrite the guidance, but “The Tan Sheet” combs through individual comments to highlight the finer points.

HHS Secretary Sebelius also sent a chill through the drug industry when she blocked Teva Pharmaceutical Industry’s attempted full OTC switch of emergency contraceptive Plan B. We look at why Sebelius overrode FDA’s recommendation to make the pill available OTC to all females of childbearing age, and analyze the potential impact the interference could have on future switch attempts and the potential creation of a third drug class.

We also look at FDA’s enforcement priorities for the New Year and its progress on foreign food facility inspections.

Don't get caught out in the cold. Make "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.

OTC/Nutritional News From "The Tan Sheet": FDA Acts Against GMP Violator, Petition Seeks NDI Guidance Withdrawal

Happy Thanksgiving from your friends at "The Tan Sheet"! Our Nov. 28 issue will feature stories on supplement adulteration and Rx-to-OTC switch self-selection studies, as well as an interview with the CEO of Capsugel.

In the meantime, check out the latest OTC/nutritional news below.

 

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. No credit card required.

Also, follow "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: The Dog Days Of Summer

 

Industry resistance to FDA’s draft dietary ingredient guidance continues to simmer as summer's sweltering days drag on, and the agency says it will wait out the heat before responding to the mounting complaints until after the comment period ends Oct. 3, according to a story in the latest issue of “The Tan Sheet.”

“The Tan Sheet” also looks at how some firms are trying to beat the heat. Desert Labs, for example, is launching a cold product – Ice Cube Diet – and cooling its claims to avoid increasing enforcement in the hoodia supplement market. Companies in the prebiotics market, on the other hand, could flourish in the heat in part because prebiotics do not require refrigeration, unlike most probiotics, which makes them well suited for diverse medical foods.

[Find out what else is hot in the OTC and nutritional industries by signing up here for a free 30-day trial subscription of “The Tan Sheet.”]

FDA Regulation Of Homeopathics Does Not Pre-empt Damages Claims – Court
A federal judge rejected an argument that FDA’s regulation of homeopathic drugs pre-empts a state consumer protection law.

FDA NDI Notification Draft Guidance Contradicts Final Rule – Ullman
FDA contradicts its final rule on new dietary ingredient notifications with its draft guidance requiring notifications for all supplements containing an NDI, food and drug attorney Marc Ullman contends.  

NuMe Among Firms With Gut Feeling About Burgeoning Prebiotics Space
Prebiotics could grow from a currently “nonexistent” market to surpass the flourishing probiotics category in both revenues and supporting science, the chief executive of a prebiotics developer says.

OTCS

• OraSure Plans To File Over-The-Counter HIV Test Application By Year End

DIETARY SUPPLEMENTS

• Desert Labs Seeks To Overcome Hoodia Market’s Reputation
• NDI Notification Draft Guidance Seminar In Brief

IN BRIEF

• GSK touts smoking-cessation brands' allure
• Prestige pulls Compound W from kids' TV
• Phytosterols claim rule comments accepted
• Petition seeks FSMA warehouse exemption
• FDA gives OKs for Superba GRAS, NDI
• Sunsweet brings Function Drinks aboard Sales & Earnings In Brief

SALES & EARNINGS IN BRIEF

• NBTY moves to "everyday low" pricing
• Vitacost absorbs loss as it preps expansion
• Economic woes weign on Reliv
• ProPhase inches toward profitability
• Acquisitions boost Atrium sales

REGULATORY

• Collaboration On Foreign Inspections Helps FDA Improve Resource Allocations

RESEARCH & DEVELOPMENT IN BRIEF

• Phytosterols boost Rx cholesterol treatment
• Combination of analgesics works best
• Prenatal folic acid does not cause asthma
• Vitamin D could decrease mortality

PEOPLE

• People In Brief

-- Elizabeth Crawford (e.crawford@elsevier.com)
 

 

OTC/Nutritional News Roundup

 
In this week's roundup...

Supplement firms contemplate FSMA user fees ... Oklahoma battle brews over local PSE laws ... Circulation journal looks at CVD benefits of functional foods

This Week In OTCs And Nutritionals: Table Of Contents

 

Johnson & Johnson and Tylenol are back in the headlines in this week's issue of "The Tan Sheet," but this time the news is not about recalls. Rather, the firm's McNeil Consumer Healthcare subsidiary makes waves by lowering the maximum daily dose of the Extra Strength painkiller to improve the product's safety profile.

FDA's new dietary ingredient draft guidance also continues to make headlines as industry claims it is a "radical departure" from the Dietary Supplement Health and Education Act of 1994 and that the agency underestimates the cost of compliance.

Merck KGaA's appointment of a new consumer business head and Colgate-Palmolive's launch of a toothpaste to compete with whitening products also catch our eye this week.

[Stay updated about the goings-on in the OTC pharma and nutritional industries featured in "The Tan Sheet" with a  free 30-day trial subscription by clicking here.]

McNeil Lowers Recommended Maximum Dose For Extra Strength Tylenol
McNeil Consumer Healthcare lowers the maximum daily dose indicated on labels of Extra Strength Tylenol, the first in a series of dosing changes for the firm’s acetaminophen-containing products

Merck KGaA Appoints Novartis, J&J Veteran As Consumer Division Head
Merck KGaA appoints a pharma industry veteran without OTC sector experience, Udit Batra, to head its Consumer Health Care unit

FDA Final Rule For OTC Inhaler Labeling Requires Death Warning
FDA disagrees with industry comments regarding the health risks of using OTC asthma inhalers, rejecting suggested language for the final monograph covering asthma and bronchodilator drugs

OTC/Nutritional News Roundup: Fireworks Edition

 
The overhead colors and explosions get the attention in firework displays, but a fuse must be lit to send each Roman candle, spinning wheel or weeping willow skyward. As Independence Day approaches on July 4, with fireworks ready in backyards, ball fields and parking lots around the country, we find some fuses lit in the OTC drug and nutritional product arenas.

J&J says no to report of joint OTC/Rx marketing, according to a VP…
Sen. Durbin wants what from dietary supplement firms? AHPA asks… 
Rhode Island ready to impose OTC sales tax, lawmakers indicate…

["The Tan Sheet" is your weekly source for all the news -- from fuse to finale -- in the OTC drug and nutritional product markets. Click here for a free trial.]

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.