OverTheCounterToday

Caution: Product May Contain More Than Just Nuts

The finding of salmonella in peanut butter and peanut paste from a Georgia facility has had ripple effects across the landscape of packaged foods. Ice cream, cereal, cookies and even nutritional and energy bars containing tainted peanut butter have been recalled by the hundreds, and the list of affected products continues to grow.

In our Jan. 26 issue, The Tan Sheet examines the ways in which dietary supplement firms have set standards of testing and supply chain management that industry experts say should prevent the “spread” of lax manufacturing oversight to their industry.

Separately, we look at how FDA has handled this latest outbreak of a foodborne contaminant. Former FDA execs and consumer advocacy groups alike are unimpressed with the agency’s seeming inability to protect consumers, but not all are convinced that radical change to the food safety regulatory structure is the answer. Check out the full story below.

FDA says store brand jarred peanut butter is still safe.

 

 

Nonprescription Alli approved in Europe: First Centralized EU Switch

GlaxoSmithKline has received final EU approval to market weight-loss drug alli (orlistat 60 mg) in all 27 EU countries and Norway, the company said in a press release Wednesday.

While GSK is touting alli as the first licensed nonprescription weight-loss drug in Europe, the approval has greater significance for the industry at large as the first Rx-to-OTC switch approved under Europe's centralized procedure.

But with regulatory structures varying across member states, individual nations are left to determine for themselves how the drug will be sold, in particular whether it will be sold truly OTC, Or General Sales List, as it's called in the U.K., or behind the counter (Pharmacy class in the U.K.)

For more detail, read the Tan Sheet's coveragefrom October, when alli cleared the European Medicines Agency. Or read a free reprint, below. This story contains links to more great in-depth stories, including a look at how alli has performed in the U.S., and what hurdles face drug makers trying to switch products OTC in Europe. These links will work only for subscribers, but you can subscribe or get a trial here.

Alli Pioneers EU Centralized Process For Nonprescription Switch 

Sharfstein Speaks

Our colleagues at the IN VIVO Blog are keeping a close eye on Baltimore City commissioner of health Joshua Sharfstein, a finalist for the post of FDA commissioner. Is he headed to Washington? Check it:

Is he Headed to Washington?

During a Baltimore City rally for Barack Obama on Saturday, Dan Rodricks, a host for the local National Public Radio station, WYPR, got a coveted interview with a Baltimore official who has been making national headlines.

FDA Commissioner Search at an End?

With the presidential inauguration nigh, the incoming administration appears to be moving rapidly to put new leadership in place at the FDA. Our colleagues at the IN VIVO Blog have been working feverishly to track the candidates for the permanent post. They have heard a pick has been made and we are waiting only on an announcement from the transition team. Read the IN VIVO blog post here.

And in the meantime, former FDA Chief Scientist Frank Torti was named Acting Commissioner. Our Pink Sheet Daily colleagues took a look at his agenda. Here's an excerpt, below, and a link to the full story.

 Torti's Next Hundred Days: Active, Not Just Acting FDA Commissoner
 
Frank Torti might not be in charge of FDA for very long, but he seems determined to make the time count.

NDAC Tentatively Slated for April/Food Committee in May

FDA's Nonprescription Drugs Advisory Committee will (tentatively) ride again in April, according to a Federal Register notice FDA posted today, listing tentatively scheduled 2009 advisory committee meetings for its various centers.

Per standard protocol, FDA isn't saying what they have in mind for the meeting's topic. Another panel with a TBA April meeting is the Drug Safety and Risk Management AC, which may or may not be related.

The most recent convening of NDAC - and the commitee's sole 2008 meeting - was a joint panel with the Antiviral Drugs committee, to discuss possible plans and applications for emergency home stockpiling of influenza MedKits containing antiviral drugs such as Roche's Tamiflu, for use in case of a pandemic. Late in 2007, the panel reviewed Merck's statin Mevacor, examined the efficacy of cough-cold ingredient phenylephrine, and recommended against the use of certain cough/cold ingredients by 2 to 5 year-olds.

But to see some of the likely candidates for Rx-to- OTC switch in 2009, take a look at The Tan Sheet's chart and stories about the developing switch landscape here and here.

Our dietary supplement readers will want to note the agency's food center's food advisory committee is tentativley scheduled to hold a meeting May 20 and 21.

Zegerid Switch Application Elicits FDA Questions

FDA has indicated to Schering-Plough Healthcare Products that the firm’s Rx-to-OTC switch application for the proton pump inhibitor Zegerid (20 mg omeprazole/sodium bicarbonate) is not ready for approval.

FDA contacted S-P Jan. 13 with a “complete response letter.” The agency uses the complete response format to state it has completed its review of a new drug application and to explain its reasons for deciding the product is not ready for approval.

S-P licensed Zegerid for the OTC market from drug originator Santarus in October 2006 and submitted the switch application in March 2008.

Sea Changes: Tan Sheet Top Stories of 2008

2008 was a dramatic year for the OTC drug and dietary supplement industries.The Tan Sheet has assembled our top 17 stories of 2008 into 10 topics that defined the changing regulatory and business environment. Subscribers can click through on any item on the list, or keep scrolling and read our narrative tour of these events and trends below, with more chances to click.

Nonsubscribers? Get a free trial or a sign up for a sub here.

Congress Presses FDA To Speak Up On OTC/Supplement Combo Products

OTC Switch Offers Firms Opportunities To Diversify Earnings - Morgan Stanley

Switch Case Study: Alli Review Contrasts OTC, Rx Division Perspectives

FDA Call For Pediatric Cough/Cold Input Signals New Rule Is A Long Way Off

With Democrat In White House, "More Aggressive" FDA Comes Into Focus

P&G Says Zegerid Switch Proposal Should Drop "Immediate Release" Claim

J&J Harnessing Pharma Business Advantages For Global OTC Growth

Bayer's Aspirin/Phytosterols Combination May Draw FDA Warning

P&G Focuses On Consumer Health, "Deemphasizes" Pharma

Managed Care Influences OTC Switch With Zyrtec As Model - Nielsen

As FDA Eyes Cough/Cold Changes, Alternative Products Aim For Mainstream

Will Bayer Supplement-Drug Combo Draw Other Firms Into New Market?

FDA Working Group Considering Changes To OTC Cough/Cold Monograph

The JUPITER Results: Will The Planets Align For OTC Statins?

Congested OTC Monograph Process Can Leave Manufacturers Confused

Early Attention To Marketing Can Make Or Break OTC Switches - Consultant

Schering-Plough Cutbacks Underscore Consumer Business Importance

When an iconic drug brand drew scrutiny on Capitol Hill for possibly violating FDA’s policy against combinations of drugs and dietary supplements, OTC and supplement interests took notice.

OTC Deals In Germany

The OTC unit of German firm Ratiopharm could be sold either as part of a deal for the whole company, or split-off as a separate sale, following the death of founder Adolph Merckle, Reuters reports. Reuters sees Teva as a likely buyer.  Read Financial Times' story here.

Meanwhile analysts are eyeing another potential OTC deal in Germany. We give you coverage from the Tan Sheet below. And click here for a free trial of the leader in OTC drug and dietary supplement market news andanalysis.

Merck KGaA Consumer Business Could Flourish In The Right Hands – Analysts
 
Merck KGaA’s weak consumer health business could be an acquisition target for a larger, more geographically diverse and innovative firm, such as Sanofi-Aventis, according to an analysts’ report.

Diet Coke Plus Warning Letter is the real thing

Companies selling "functional" beverages be aware. FDA has taken a stance on a very prominent target that sends a message to makers of drinks fortified with vitamins and minerals. In a letter to Coca-Cola, the agency says it is not appropriate to fortify snack foods such as carbonated beverages. That's a standard that could give FDA a lot of leeway to go after many functional beverages including nutrition, sport and energy drinks. The Tan Sheet breaks it down for you in our story below.  For some back story on FDA's approach to this market, subscribers can read a story from our archives here. To sign up for a subscription or a free trial, click here.

              

FDA Warning Letter To Coke Could Mean Trouble For Health Drink Market 
 
 
An FDA warning letter to Coca-Cola states Diet Coke Plus is misbranded in part because it is inappropriate to fortify carbonated beverages.

 

The Character "Heroes" Left Out

Maybe you are an over-the-counter product marketer looking for inspiration. Or maybe you miss the special breed of superheroes featured on The Tick. Or maybe you forgot some people on your holiday card list and want to catch them with a tasteful e-card. Whatever the situation, please click to learn about the adventures of C. B. Fleet's Eneman.

 

For slightly more sober coverage of Fleet and other companies, Join us at "The Tan Sheet" for news and analysis of business and regulatory issues for the OTC drug and dietary supplement industries.