OverTheCounterToday

FDA's 2009 Countdown

With only December standing between us and the futuristic-sounding "2010," FDA still has some things to check off its to-do list. Here's what we could see from the agency in the remainder of 2009, listed in order from most to least likely.

Zegerid switch decision. FDA told Schering-Plough and Santarus in June to expect a December "action date" on the proton pump inhibitor's Rx-to-OTC switch application. In January, the switch hit a roadblock as FDA indicated via complete response letter it was not ready to approve Schering's application, which we reported here. In recent months, Zegerid's originator Santarus has shown some confidence in the switch approval, which would bring the firm millions in milestone payments from the licensee. We noted here that Santarus expects Schering/Merck to launch OTC Zegerid in the first half of 2010, assuming agency approval.

Transparency Task Force recommendations. The group of FDA senior officials is slated to release its draft recommendations for agency transparency policy in December or January. Principal Deputy Commissioner Josh Sharfstein, who chairs the task force, said in a recent interview with "The Pink Sheet" that the group continues to wrestle with the question of "what is the right thing to do" in terms of publicizing private or proprietary information. The supplement industry hopes, as we reported here, that greater transparency will mean improved communication with the agency and less ambiguity.

This Week In OTCs And Supplements: Table Of Contents

 

 

Last week, as we eyed the bountiful contents of our holiday tables, we gave thanks for you, our loyal readers. This week we're back, with another bountiful table of contents from the Nov. 30 issue of "The Tan Sheet."

FDA Identifies "Fatal Flaws" That Block Approval Of Health Claims
FDA likely will refuse new health claims applications if petitioners fail to provide relevant studies in healthy humans that evaluate the relationship between the substance and the disease, an agency official says.

FDA Requires Liver Injury Warning On Acetaminophen Stick Packs, Sachets
Acetaminophen products sold in stick packs and sachets must carry warnings about the risk of liver injury by April 29, 2010, a technical amendment to the final rule for internal analgesics says.

GRAS Food Ingredient Process Faces Possibility Of Mandatory Notifications
A Government Accountability Office investigation may foreshadow administration interest in amending the "generally recognized as safe" food ingredient notification program, potentially requiring firms to submit GRAS determinations to FDA.

This Week In OTCs And Supplements: Table Of Contents

 
  
Today we begin a weekly post of the table of contents for the current issue of "The Tan Sheet." As often as we refer to previous stories we've reported related to news items in our blog, we decided the natural next step is to  let you know what we've reported in our current issue.

Plavix Stomach Drug Interactions Upset Heartburn Market
An FDA warning that people prescribed Plavix (clopidogrel) should not take specific heartburn drugs creates a significant opportunity for other OTC products in the category "to make some hay," a marketing consultant says.

Co-Packaging Enters Gray Area As Option For OTC/Supplement Combos
Experts disagree whether creative co-packaging of OTC drugs and dietary supplements is a legitimate alternative to problematic combination products or simply another regulatory quagmire.

Mead Johnson Likely To Draw Suitors Following BMS Split
Mead Johnson's impending split-off from Bristol-Myers Squibb, announced Nov. 16, makes the rapidly growing nutritional company an appealing acquisition target for the back half of 2010, analysts predict.

OTC/Supplement Business Roundup

We like a good safari story as much as the next insightful and timely OTC drug and nutritional product industries blogger, so we wanted to post these items about a firm on the acquisition trail, a lobby group cutting to the chase on health care reform and a commentator barking up the supplement regulatory tree.

Reckitt ready, but Colgate out of reach: The Financial Times reports...

Lobby group slams axing OTCs from FSAs: The Wall Street Journal reports ...

Conservative criticizes DSHEA: According to a CNN online piece ...

Upset In The Heartburn Market?

 
An FDA warning could significantly shift OTC heartburn drug use among people who are prescribed Plavix (clopidogrel) to prevent blood clots.

The agency said Nov. 17 that U.S. consumers who take Plavix should not take the proton pump inhibitors omeprazole or esomeprazole or the H2 blocker cimetidine to reduce stomach acid because they also reduce the effectiveness of the blood-thinner.

This may be good news for marketers of antacids and H2 blockers other than cimetidine.

"The Tan Sheet" explained FDA's decision and how the change could affect the OTC drug market here in Elsevier Business Intelligence's "Health New Daily" online publication. We've also looked at regulatory issues concerning OTC PPIs here and at competition in the PPI market here.

We will expand our analysis of FDA's action in our Nov. 23 issue.

(Not a subscriber to "The Tan Sheet"? Click here for a free trial.)

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

OTC/Nutritional Business Roundup

 

We're not spinning off anything here at "The Tan Sheet," but we'd like to bring to your attention these news items today spinning around the markets we cover.

BMS goes "fully" biopharma: Bristol-Myers Squibb says it will spln off its 83 percent stake in Mead Johnson Nutrition to move entirely into the biopharmaceutical arena.

IFT says tracing means connecting the dots: The Institute of Food Technologists recommends requiring third-party food safety auditors be capable of tracing products.

AHPA makes its pen mightier than steroids: Trade group President Michael McGuffin writes a letter to the editor about inaccuracies in a Boston Globe editorial on FDA's authorities over dietary supplements.

Novartis Enters PPI Fray; Reynolds Tobacco May Buy Into Cessation

We're working on plenty of OTC drug and nutritional product market stories this week, but today two items are simply burning to be posted.

Novartis spares little promoting Prevacid 24HR launch …

Reynolds American looks at quitters' market ...

OTC Business News Roundup

 
In today's roundup...

Health care reform debate moves to Senate…

India reconsiders OTC sales of emergency contraceptives…

Odd taste and smell prompt Tylenol recall…

Humpday OTC/Nutritional Chatter

It's that magical time of year when the four major sports overlap for an all-too-brief few days. But around our water cooler (or countertop water filtration system) OTCs and nutritionals are still the word. Here's a sampling:

Bodybuilding.com steroid "supplements" retreat from market in voluntary recall...

OTC dosing device guidance pours forth from FDA...

Glaxo adds alli warning in EU...

Vitamin Shoppe, Vitacost.com start reporting earnings with a bang...

Dietary Ingredient Science In Limbo

 
The development of ingredients that have been part of abandoned drug applications is at stake because FDA has failed to clear an important pathway to market, dietary supplement champions on Capitol Hill argue.

"The Tan Sheet" reported this and explained why it's important to supplement manufacturers here.

We report unique, critical stories like this every week. Read about the threat to the Dietary Supplement Health and Education Act and why companies need to act now to protect it here ($ subscription required).

Here's more on the development of dietary ingredients, "FDA Must Lift 'Limbo' Over Trials In Supplement Development – Caucus"...