OverTheCounterToday

FDA Panel Supports Lower Acetaminophen Dose, Liquid Limits, But Spares Combo Products

In what could be a major blow to manufacturers, acetaminophen sold in 500 mg tablets, such as Tylenol Extra Strength, will come off the OTC market if FDA follows a joint advisory committee's recommendations.

Voting today on a number of potential regulatory and risk-mitigating actions, panelists with expertise in nonprescription and anesthetic drugs and drug safety and risk management also overwhelmingly supported limiting liquid acetaminophen products to a single concentration, with only one member opposing and 19 ranking it a high priority. However, the industry may be spared the additional pain of losing combination products that include acetaminophen and other ingredients, such as many cold and flu products.

"The Tan Sheet" detailed manufacturers' objections to FDA's proposals concerning acetaminophen safety here. 

OTC And Nutritionals Business News Roundup

In today's roundup...

FDA Panel Begins Acetaminophen Assessment: McNeil Consumer Healthcare says label changes and innovative package designs will more effectively reduce the risk of liver damage from acetaminophen overdosing than FDA's proposal to remove certain forms of the drug from the market.

Watson Hints At August Delivery For Plan B Generic: A Watson Pharmaceuticals spokeswoman confirms that the company is pursuing approval of a nonprescription levonorgestrel equivalent, aiming to make it available upon the expiration of Teva's market exclusivity August 24. The only wild card remaining is the speed of FDA's approval process, she says.

NSAID Labeling Rule Cost To Industry Explodes: FDA corrects its April 29 final rule requiring organ-specific label warnings for OTC products containing acetaminophen or nonsteroidal anti-inflammatory drugs. The revised final rule, according to an advance June 30 Federal Register notice, bumps up first-year, one-time, industry-wide re-labeling costs from $32.6 million to $62.7 million.

CSPI Puts FDA In The Loop On Bayer One A Day Multivitamins: The Center for Science in the Public Interest says it is not enough for Bayer, without FDA intervention, to remove qualified health claims linking selenium to prostate cancer prevention from its One A Day Men's multivitamins labeling and marketing.

Whey Protein Supplier Recalling Ingredients With Salmonella Concerns: FDA announces the latest recall of salmonella-contaminated products, this time from the Plainview Milk Products Cooperative. Two years worth of ingredients, including whey protein and fruit stabilizers, are being recalled, the Plainview, Minn.-based company says.

Panel To Rank Acetaminophen Priorities

An FDA joint advisory panel will vote on prioritizing the agency's options concerning whether to take certain types of over-the-counter acetaminophen products off the market in addition to voting on the proposed options.

 

 

"The Tan Sheet" is following every word and noting every presentation today as FDA kicks of the two-day meeting of the nonprescription drug, safety and risk management and anesthetic drug advisory committees.

 

Reporters Elizabeth Crawford and Christopher Walker are there, and Walker is posting notable developments – such as FDA officials' indication that the panel will vote on ranking the agency's priorities – on Twitter as well as here on Over the Counter Today.

 

To reduce the risk of acetaminophen overdose, an internal FDA working group proposed options including eliminating the ingredient from all OTC combination products, reducing maximum available tablet strength to 325 mg, lowering the daily adult dose, standardizing liquid suspensions with the ingredient and limiting package size.

 

Crawford's piece on drug manufacturers' take on FDA's possible acetaminophen actions from this week's issue of "The Tan Sheet" is here.

 

"The Tan Sheet" next week will offer more reporting from the June 29-30 meeting, and break down what the experts' recommendations mean for manufacturers and other stakeholders in the OTC market.

 

Not a subscriber to "The Tan Sheet"? Get a sub or a free trial here.

 

-- Malcolm Spicer (m.spicer@elsevier.com)

 

FDA Looms Large As Bayer Surrenders Selenium Cancer Claims

The new FDA has indicated that playing fast and loose with health claims won't be tolerated, and industry seems to have gotten the message. Bayer says it will discontinue labeling and advertising language that links selenium in its One A Day Men's multivitamins to a reduced risk of prostate cancer -- without any direct FDA intervention.

While a Bayer spokeswoman calls the move "a result of our evaluation of the evolving science," the company notes it has seen FDA's June 19 decision to label selenium's preventive effect on prostate cancer "highly unlikely" (as Over The Counter Today blogged here). 
 
"Even though the FDA has not made an official communication about the use of the previously approved qualified health claim, 'Selenium may reduce the risk of certain cancers,' we have decided to no longer utilize this language in our promotion and labeling of our products," the spokeswoman writes in a June 25 e-mail.

FDA Panel To Mull Acetaminophen Questions

A panel of experts will advise FDA June 29 and 30 on whether to take certain types of over-the-counter acetaminophen products off the OTC market.

No one is on top of this issue and what it means for your business like "The Tan Sheet," as our exclusive profile of some of the panelists reveals. If FDA's regulation of OTC drugs affects your business, you need to read Elizabeth Crawford's story, Meet The NDAC, Minus One... provided for free below.

(On June 25, look for her piece on manufacturers' take on FDA's possible acetaminophen actions at "The Tan Sheet" here [$]).

Reporters Crawford and Christopher Walker will be at the meeting, so look for us there. We'll provide up-to-the-minute reporting and then break down  what it means for your business in the future.

Enjoy this complimentary story, below. For an accompanying chart of the NDAC members, read the Tan Sheet here (subscribers only. But get a sub or a free trial here,). And for a look at the potential impact of the acetaminophen issues on the OTC industry,read this).

Meet The NDAC, Minus One, As Conflict Of Interest Rules Come Into Play
New Nonprescription Drugs Advisory Committee member James Kehrer's expertise on acetaminophen toxicity should make him a key figure at FDA's upcoming meeting on the drug, he says.

But when NDAC convenes with two other committees June 29-30 to discuss acetaminophen hepatotoxicity risks, Kehrer will be notably absent.

Clock Ticking On FDA's Tobacco Center

The 90-day deadline for FDA to establish a Center for Tobacco Products is running with President Obama signing legislation giving the agency authority to regulate tobacco products.

At a ceremony in the Rose Garden, Obama said the Family Smoking Prevention and Tobacco Control Act is “a step that will save lives and dollars.” Noting the bipartisan cooperation behind the bill’s passage, the president said the law is “a victory for health care reform, as it will reduce some of the billions we spend on tobacco-related health care costs in this country.”

Following the signing, FDA updated its Web site to include a page for tobacco, including a link to smoking cessation products, both Rx and OTC. 

“FDA looks forward to taking on this challenge and in doing so will partner with public health leaders at our sister agencies, at the state level, and in localities all around the country. FDA will perform its duties by using the best available science to guide the development and implementation of effective public health strategies to reduce the burden of illness and death caused by tobacco products,” FDA Commissioner Peggy Hamburg says on the Web page. “FDA will seek input from the public as we begin working to implement the act.”

The act gives FDA the responsibility to regulate the production, sale and marketing of tobacco products. User fees based on tobacco firms' market shares will fund the center, with FDA entitled to collect $85 million in fiscal 2009, building up to $712 million in 2019. Proponents of the law promised FDA's funds for other activities will not be diluted as a result of the new responsibilities.

FDA Finds Selenium "Highly Unlikely" To Reduce Prostate Cancer Risk

FDA has concluded that minimal evidence supports the linking of selenium consumption and reduced risk of prostate cancer, likely delivering a further blow to Bayer One A Day Men’s multivitamins products containing the mineral and touting its prostate health benefits.

In a decision dated June 19, the agency informs attorney Jonathan Emord that it “intends to consider the exercise of its enforcement discretion” for a claim stating the following:

Two weak studies suggest that selenium intake may reduce the risk of prostate cancer. However, four stronger studies and three weak studies showed no reduction in risk. Based on these studies, FDA concludes that it is highly unlikely that selenium supplements reduce the risk of prostate cancer.

CSPI Threatens To Sue Bayer Over Vitamin Prostate Cancer Claims

The Center for Science in the Public Interest intends to file suit against Bayer Healthcare if the firm does not stop claiming its Bayer One A Day Men’s Health Formula and Men’s 50+ Advantage multivitamins can help reduce the risk of prostate cancer.

Bayer's proof of selenium's anti-cancer effects, CSPI alleges, comes from the Selenium and Vitamin E Cancer Prevention Trial -- SELECT -- which the National Institutes of Health suspended in 2008 after selenium showed a potential link to adult onset diabetes and little effect on cancer rates. "The Tan Sheet" reported on the disappointing study results here. 

CSPI cites a Bayer radio advertisement that mentions the possible reduced risk of prostate cancer through selenium intake. In a 15-second TV spot running regularly during Major League Baseball games, a Little League coach says, “I thought a complete multivitamin was enough, until I learned one in three men will face prostate issues. One A Day Men’s has more selenium than Centrum to support prostate health.” The center claims use of the term "issues" translates directly to cancer.

Health Care Legislation Percolates, With OTC Benefit Cuts A Possibility

Health care reform legislation is likely to emerge from both the House and Senate in coming days or weeks, and it remains unclear whether cuts will be made to benefits that allow OTC purchases in order to help fund a health care system overhaul.

In May, the Senate Finance Committee released a report on policy options for financing the reform. One possibility includes modifying or repealing the tax exclusion for employer-provided reimbursements under flexible spending and health reimbursement arrangements. Such plans often permit employees to purchase OTC health products with funds excludible as gross income.

Another option offered by the committee says the definition of a qualified reimbursable medical expense under FSAs and HRAs could be narrowed to exclude nonprescription medicines.

FDA Questions Safety Of Zicam Products

FDA today advised consumers not to use Matrixx Initiatives’ intranasal Zicam products after receiving more than 130 adverse event reports that the zinc-containing OTC products cause anosmia, loss of the sense of smell.

The agency issued a same-day warning letter to Matrixx to stop marketing the homeopathic products. The Scottsdale Ariz.-based firm must respond within 15 working days with a plan to remove existing inventory from the marketplace.

The products, major growth drivers for the company, include Cold Remedy Nasal Gel and Cold Remedy Swabs. FDA also questions the safety of a discontinued product, children’s size Cold Remedy Swabs.

Previously, FDA excercised enforcement discretion under its homeopathic drugs policy, allowing Matrixx to market Zicam without a new drug application. However, the safety risk of anosmia prompted FDA to take enforcement action.