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.
"The Tan Sheet" this week looks at adverse event reporting data that may point to a kidney stones risk among consumers taking GlaxoSmithKline's weight-loss drug alli (orlistat). Not exactly opportune timing for Glaxo, which is trying to unload the drug, along with other non-core OTCs.
Our Jan. 16 issue also features stories on a wrongful death lawsuit against Johnson & Johnson relating to its recalled OTC products; Novartis' recalls of Bufferin and Excedrin after quality control issues arose at one of its plants; and Perrigo's forthcoming private-label Mucinex launch.
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.
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"The Tan Sheet" this week features stories on some vociferous opposition to FDA's new dietary ingredient notification draft guidance and the government's cost estimates associated with compiling an ingredient dossier, as well as the latest on congressional funding for FDA's food safety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.
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.
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.
"The Tan Sheet" this week reports on FDA's supplement enforcement priorities with a dispatch from the Council for Responsible Nutrition's recent conference. FDA's Division of Dietary Supplement Programs plans enforcement activity in the areas of new dietary ingredients, good manufacturing practices and adverse event reporting. Also from the CRN conference, a story on what retailers expect to see from supplements and OTCs in the areas of social media marketing and consumer education.
Our Oct. 31 issue keeps pace with the flurry of quarterly earnings reports. In addition to news on Procter & Gamble's planned across-the-board price increase and Perrigo's underperforming OTCs and nutritionals, we've got highlights from Bayer, Colgate-Palmolive, GlaxoSmithKline, Mead Johnson Nutrition and many other reporting companies.
As always, there's plenty more in the latest "Tan Sheet," including a look at how FDA might learn from Health Canada's revised probiotics regulations, scrutiny of Allegra's allergy relief claims, and industry's defense of spray sunscreen safety.
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.
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.
Continue reading "This Week In OTCs And Nutritionals: Switch, GMPs, Abbott " »
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.]
Continue reading "This Week In OTCs And Nutritionals: Tough-Pill-To-Swallow Edition" »
