OverTheCounterToday

CHPA Opposes Reverse Switch for Pediatric Cold Drugs

Speaking of Dr. Sharfstein, what's the status of that pediatric cough/cold petition? FDA is still working on a proposed rule to amend the monograph. Read about that in the Tan Sheet here.

Meanwhile, the trade association for OTC drug manufacturers, the Consumer Healthcare Products Association, has filed comments with the agency saying an OTC-to-Rx unswitch of the products would have a negative public health impact. Read their 384 pages of comment here. Or read The Tan Sheet's story here or below:

Pediatric Cough/Cold “Reverse Switch” Will Not Increase Safety – CHPA

A potential "reverse switch" of pediatric cough/cold OTC drugs to prescription status would not address concerns about misuse of the products, the Consumer Healthcare Products Association says.

Joshua Sharfstein: the Links

He's getting a lot of press these days, as a figure mentioned for the short list of possible FDA commissioner candidates under the Obama administration. But, putting that guessing game aside for the moment, Baltimore Commissioner of Health Joshua Sharfstein is in a position right now to have a lot of influence on the shape and direction of the agency anyway: he's working on the administration's transition team, specifically evaluating the FDA.

At The Tan Sheet, we knew him before he went pop. Back when he petitioned FDA to take pediatric cough/cold products off the market, and when he recommended to the advisory panel considering the request that parents treat coughs and colds with "love." And liquids.

Whether he gets named to run the agency or not, we think it's a good time to take a close look at Joshua Sharfstein so we've gathered together some links to a few key stories.

We discussed Sharfstein's connections (including his  connections to Henry Waxman, and the California Rep's rising prominence in terms of health legislation) in a recent piece on former FDA commissioner David Kessler, here .  Search our archives for more.

The Baltimore Sun profiled him here. And the Wall Street Journal's health blog, here. And to read him in his own words, here's a 2006 Baltimore City paper interview, when he started as health commissioner for the city.

Procter & Gamble Looks to OTCs as a Safe Bet

The current economic climate is driving interest in OTC drugs and self-care. Some pharma companies have made the choice in recent years to move away from OTCs to focus on core pharma (Pfizer) and others have made increased investments in OTC as part of a diversification strategy (Johnson & Johnson). Now, consumer products giant Procter & Gamble is moving away from investment in prescription drugs to focus more directly on OTCs. Read about the factors behind the firm's decision at The Tan Sheet, the leading source for news and analysis of the OTC drug and dietary supplement industries.

Meanwhile, Reuters reports on Wal-Mart's take on prescription and self-care spending in the weak economy here. And The Tan Sheet has been closely following the increasing prominence of private label products as cost-savings grow in importance for consumers, here.

Or learn how to subscribe or sign up for a free trial here. Here's our P&G story:

P&G Focuses On Consumer Health, “Deemphasizes” Pharma 

 
Procter & Gamble says consumer health trends are on its side as the company increases focus on its consumer health business and moves away from pharmaceuticals.

Rose Sheet Roundup

Keep up with crucial analysis and developments in the cosmetics and personal care industries with The Rose Sheet. Subscribe or get a free trial here. Read on below a quick look at some of what we've been working on, including personnel changes at the Personal Care Products Council, and a petition to amend sunscreen regulations...

FDA Still Hammering Out Adverse Event Guidelines

Something is holding up FDA's guidances on the reporting of adverse events for OTC drugs and dietary supplement products. As a result, the agency has extended the deadline for compiance with the labeling requirements of the 2006 adverse event reporting law another year, to January 2010.

The Tan Sheet looks into what's behind the delay:

AER Label Compliance Extended Until 2010 For OTCs, Supplements

 
FDA is extending the deadline for adverse event labeling requirements for OTC drugs and dietary supplements until January 2010 because it has yet to finalize its guidance to comply with those regulations.

A Stake in the Heartburn Market

In the OTC drug market, the right claims can be crucial to competing in crowded categories. Procter & Gamble had a big hit with the first-in-class Rx-to-OTC switch of the proton pump inhibitor Prilosec  OTC  (omeprazole). But with private label competition eroding market share since earlier this year, P&G is hoping to block certain competitive claims from Schering-Plough's expected OTC switch of Santarus' Zegerid, an immediate release formulation that combines omeprazole with sodium bicarbonate for more rapid absorption. In fact, if you say "immediate release" around any lawyers from P&G, enunciate clearly: in a petition to FDA intended to limit certain claims for Zegerid, P&G says consumers are likely to be misled by the phrase, confusing "immediate release" with "immediate relief." But one consultant thinks the petition won't hold water, and says that sponsors should be able to win some kind of rapid onset claim from FDA. The Tan Sheet, in an exclusive analysis, takes a close look at the petition and its chances.

Subscribe or sign up for a free trial to The Tan Sheet here.

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

The proton pump inhibitor Zegerid should not be allowed on the over-the-counter market with the label claim "immediate release," says Prilosec OTC marketer Procter & Gamble.

In a citizen petition submitted Nov. 17, P&G asks FDA not to approve an OTC version of Zegerid (omeprazole/sodium bicarbonate) with "misleading" labeling that could cause consumers to believe the PPI will provide "immediate relief" for heartburn...

You Can't Spell FDA Without "F"

Over-the-counter drug makers: learn why Joshua Sharfstein, Baltimore's commissioner of health (and the lead petitioner to take OTC pediatric cough/cold drugs off the market) may be on the short list to head the Food and Drug Administration.
Read below, or in this week's issue of The Tan Sheet, about Sharfstein and about the qualities needed in an FDA Commissioner, as described by former commissioner David Kessler.

"The Tan Sheet" is the OTC and dietary supplement industry's leading source of business and regulatory analysis. Click here to start your 30-day, risk free trial of "The Tan Sheet"

Former Commissioner David Kessler says President-elect Barack Obama needs to keep the F in FDA in mind when selecting the next commissioner...

Over-the-counter drug makers: learn why Joshua Sharfstein, Baltimore's commissioner of health (and the lead petitioner to take OTC pediatric cough/cold drugs off the market) may be on the short list to head the Food and Drug Administration.
Read below, or in this week's issue of The Tan Sheet, about Sharfstein and about the qualities needed in an FDA Commissioner, as described by former commissioner David Kessler.

"The Tan Sheet" is the OTC and dietary supplement industry's leading source of business and regulatory analysis. Click here to start your 30-day, risk free trial of "The Tan Sheet"

Former Commissioner David Kessler says President-elect Barack Obama needs to keep the F in FDA in mind when selecting the next commissioner...