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": Advocates Refile Plan B Lawsuit; Plan B Available in University Vending Machine; Korea’s Wider OTC Access Stalls

This Week In OTCs And Nutritionals: Pfizer Launches Nutrition Site, Valeant Snaps Up OTCs, FDA Elevates Supplement GMPs

The Jan. 23 issue of "The Tan Sheet" features a look at Pfizer's launch of nutritionpossible.com, a website designed to educate consumers about dietary supplements as well as drive interest in the company's Centrum vitamin brand.

This week's edition also examines how consumer health products play into the amibitious growth goals of Valeant Pharmaceuticals and checks in on CMP Therapeutics, a U.K. start-up preparing to introduce an OTC nasal spray derived from chitin.

Additionally, "The Tan Sheet" has stories on FDA's elevated expectations for supplement good manufacturing practices in 2012, cooperation among supplement trade groups, 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.

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Deja Vu All Over Again: McNeil Recalls Motrin Product

McNeil Consumer Healthcare’s voluntary recall of 12 million bottles of its Motrin product marks the third consecutive year the Johnson & Johnson business ended the year recalling an OTC drug product.

In a Dec. 21 statement on the Motrin website, McNeil said it is recalling from retailers 59 lots of Motrin IB coated caplets and tablets in 24-count containers and coated caplets in 24+6-count packages -- each product contains 200 mg ibuprofen. The firm said testing of samples showed some caplets may not dissolve as quickly as intended when the products near their expiration date. The lots are being recalled "since there is a chance they could experience a similar problem as they approach expiration,” the J&J business said.

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: 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: 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: 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: 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