OverTheCounterToday

News Roundup: Taking It To The States

While FDA regulates OTC approvals at the federal level, availability of OTCs can be affected by state regulations. This week Alabama considers requiring a prescription for pseudoephedrine and a federal court in Washington will decide whether to continue requiring pharmacists to dispense emergency contraception despite religious objections.

"The Tan Sheet" is your source for the most in-depth coverage of over-the-counter pharmaceutical and nutritional industry news. For more information on a free 30-day trial, click here -- no credit card required! Check out "The Tan Sheet" on Twitter and Facebook. 

This Week In OTCs And Nutritionals: Capsugel Moves Past Pfizer, CHPA Talks Self-Selection, GNC Expands Abroad

Our post-Thanksgiving issue of "The Tan Sheet" has a lot more than leftovers. We've got an exclusive interview with Capsugel CEO Guido Driesen, who talks about the oral dosage technology firm's growth plans since being divested by Pfizer.

Inside our Nov. 28 edition, you'll find out what details the Consumer Healthcare Products Association suggests FDA should add to its guidance on self-selection studies for Rx-to-OTC switches. We've also got stories on GNC's expansion into China, Pronova BioPharma's leap from Rx omega-3 drugs to supplements, and what FDA wants industry to do about supplement adulteration.

 

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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.

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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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Exclusive OTC/Nutritional Coverage From "The Tan Sheet": PGT Healthcare

"The Tan Sheet" offers ongoing coverage of PGT Healthcare, the global consumer health joint venture between Procter & Gamble and Teva Pharmaceutical Industries. Above, Teva CEO Shlomo Yanai (left) and P&G Vice Chairman, Global Business Units Dimitri Panayotopoulos seal the deal Nov. 3.

Our contribution to "Health News Daily" on Nov. 15 took a closer look at what the firms hope to accomplish through PGT. Keep reading for a full version of that story, and check back with "The Tan Sheet" on Nov. 21 for an extended version.

 

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.

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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.

This Week In OTCs and Nutritionals: More Sunlight Edition

The end of daylight savings time means more sunlight in the morning, and "The Tan Sheet" team continues to shine light on all the top OTC and nutritional stories. In this week's edition, a consultant says consumer complaints can reveal systemic supplement GMP problems, an EU authorization process for Rx drugs could make for a more efficient centralized process for OTCs and an industry group announces a program to make detection of adulterants in herbal products less costly. And we continue to highlight quarterly earnings, including Pfizer and its outlook for OTC Lipitor. 

GMP Complaint Procedures Can Flag Broader Problems

Consumer complaints that FDA inspectors say dietary supplement firms frequently fail to address adequately could reveal systemic problems if investigated.

Phased Rx Drug Approval In Europe Could Help Switches – EU Execs

An authorization process the European Union is studying for Rx drugs eventually could help facilitate OTC switches through the centralized system, according to EU executives.   

Industry Herbal Adulterants Program Seeks To Simplify Detection

The industry-backed Botanical Adulterants Program announced Nov. 2 could make detection of herbal supplement adulteration less complicated and costly for manufacturers.

You can always fall back on "The Tan Sheet" for your OTC and nutritionals industry news. For more on a free trial subscription, click here. And don't forget to follow us on Facebook and Twitter!

"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.

Also, check out "The Tan Sheet" on Twitter and Facebook.