OverTheCounterToday

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: 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 Trade groups respond icily to new dietary ingredient notification draft guidance that they say contravenes the Dietary Supplement Health and Education Act.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.

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This Week In OTCs And Nutritionals: Rx-to-OTC Switch Tool, NDI Guidance Opposition, PGT Healthcare Interview

Our Nov. 21 issue takes a look at a risk/benefit assessment tool from the World Self Medication Industry group that could aid the development of Rx-to-OTC switch applications. We've also got an exclusive interview with the leaders of PGT Healthcare -- the new consumer health joint venture between Procter & Gamble and Teva Pharmaceutical Industries.

Additionally, "The Tan Sheet" this week features stories on some vociferous opposition to FDA's new dietary ingredient notification draft guidance and the government's cost estimates associated with compiling an ingredient dossier, as well as the latest on congressional funding for FDA's food safety activities.

 

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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.

 

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Burton, Durbin Offer Divergent Views On Supplement Safety

  


In the past week, Rep. Dan Burton, R-Ind. (above left), and Sen. Dick Durbin, D-Ill., demonstrated the range of congressional perspectives on dietary supplement safety.

Burton introduced a bill Nov. 4 to move up the dietary ingredient grandfather date by more than 12 years -- from Oct. 15, 1994, to Jan. 1, 2007. The Dietary Supplement Protection Act, H.R. 3380, would give the supplement industry a reprieve from submitting potentially thousands of new dietary ingredient notifications for products that came on the market after the Dietary Supplement Health and Education Act of 1994.

"The Tan Sheet" News Roundup: Pfizer Plots Lipitor Switch, Crest NAD Case, OTC Inhaler Measure Fails

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.

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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.

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This Week In OTCs And Nutritionals: Class In Session Edition

 
“The Tan Sheet” this week reports on a GlaxoSmithKline-backed study that shows educating consumers about the safety and efficacy of nicotine-replacement therapies could lower their concerns about the products’ prices.

We also report that Pfizer would need to learn a lot about consumers’ safe self selection if the firm wants to switch its high cholesterol treatment Lipitor to OTC, and dietary supplement industry trade groups want to learn more about how FDA will calculate the user fees authorized by the Food Safety Modernization Act.

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Education About NRT Safety Overcomes Smokers’ Cost Barrier – Study
Drug firms could educate consumers about the safety and efficacy of nicotine-replacement therapies to show the products’ value, according to recent research.

Lipitor OTC Switch Would Force Pfizer To Clear Big Research Hurdles
Pfizer would face major hurdles in research on consumers’ safe self-selection for FDA to approve an OTC switch of the firm’s cholesterol treatment Lipitor.

Supplement Industry Questions FDA's Calculations For Food Safety User Fees
Good manufacturing practice compliance becomes more critical for dietary supplement firms as FDA sets the first user fees to cover agency costs for follow-up inspections of facilities and imports and work on mandatory recalls.

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.

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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