OverTheCounterToday

Huge Headaches for the OTC Industry

Recommendations of an FDA internal working group on acetaminophen hepatotoxicity have the potential to make a big impact on companies that sell products containing the ingredient. An advisory panel meeting is slated in June to help guide FDA on what actions, if any, to take to reduce risks to patients and consumers.

In the report released May 27 as part of background materials for the meeting, the group recommends eliminating products that combine acetaminophen and other active ingredients, reducing the maximum available OTC dose, and limiting OTC package size, among others. (For a summary and FDA's drug center's overview of the options, skip to page 268 of the PDF).

Manufacturers stand to incur huge costs and reduced revenue opportunities if the agency follows all of the recommendations. Certain products and sizes would come off the market, firms would have to redesign labeling and packaging, and they could incur extensive reformulation costs and potentially even need to conduct new efficacy studies on the lower maximum doses.

For a couple of examples, Johnson & Johnson's Extra Strength products under the Tylenol line would no longer be allowed OTC, because they exceed to proposed new dosage per tablet max. And line extensions containing acetaminophen in lines like Wyeth's Robitussin and P&G's Nyquil would be eliminated as well.

(The next issues of Health News Daily andThe Tan Sheet will provide more details on the potential costs to industry. Not a subscriber? Get a free trial here).

At the meeting in June, FDA's Nonprescription Drugs, Drug Safety and Risk Management and Anesthetic and Life Support Drugs advisory committees will review the recommendations among strategies for reducing liver toxicity risk to patients and consumers using prescription and/or OTC acetaminophen.

The Tan Sheet spells out the key elements of FDA's recent work on the acetaminophen monograph here, and previews the upcoming advisory meeting here. And Tan will be at the advisory meeting, to report on where FDA might be headed, and what costs and opportunities it creates for the OTC industry.

Bloomberg has a good story on some of the recommendations and their impact here.

- Christopher Walker and Liz Crawford

Add A Dash Of Food Safety User Fees, Stir

User fees in a House draft bill for food safety reform could endanger the legislation’s chances for passage.
  
The House draft would impose broader registration and user fee requirements than its Senate counterpart.

While neither the Senate bill nor the House draft refers specifically to dietary supplements, manufacturers of herbals, nutritionals and vitamins could be affected because their products are regulated as food.

The House Energy and Commerce Committee issued draft legislation May 27 that would impose annual registration fees from food facilities to pay for FDA’s inspection costs, and additional fees when facilities must be re-inspected. FDA also would collect fees for recalls and for issuing certificates for food products approved for export, according to the committee.

The Senate bill, the FDA Food Safety Modernization Act, S. 510, would impose fees for re-inspections conducted after FDA identifies foreign and domestic firms' facilities as non-compliant with food safety regulations, but would not require annual registration fees from all food facilities.

The different user fee requirements in the House draft and S. 510 could impede passage of food safety reform during this session. The chief sponsor of S. 510, Illinois Democrat Dick Durbin, says bipartisan support in the Senate for food safety reform depends on not including general user fees in legislation.

As always, subscribe to “The Tan Sheet” or start a free trial here.

Hang Up And Shop

If they can find time between calls, consumers with cell phones will be able access more information about the OTC drugs, personal care products and other items on their shopping lists.

Colgate-Palmolive is among a number of consumer product companies exploring digital technologies to connect with consumers at the point of sale, including two-dimensional “tags” or barcodes on store shelves that allow shoppers with mobile phones to quickly access branded ads, coupons or product demos.

Already popular with marketers abroad, especially in Japan, the medium is beginning to attract advertisers in the U.S. and wide-scale use of mobile technologies among U.S. consumers indicates the timing may be right.

Jagtag is among the firms implementing 2D mobile marketing barcodes – typically a rectangular pattern of squares, dots or other geometric characters.

“There’s something really interesting about the idea of offering consumers the ability to get more content and information about their body via their mobile phone,” says Dudley Fitzpatrick, CEO and founder of Princeton, N.J.-based Jagtag.

Subscribers to "The Tan Sheet" can read here about mobile marketing opportunities for Colgate and other firms. Subscribers to "The Rose Sheet" can read here about how 2D tags work to provide information to consumers.

Subscribe or start a free trial for "The Tan Sheet" here and for "The Rose Sheet" here.

FDA Gives Firms Hawking H1N1 Remedies Tighter Deadline To Comply

FDA’s threats of near-immediate action against firms selling products with claims of mitigating or preventing the H1N1 flu virus is the sign of a fleet-footed and serious agency, says a food and drug attorney.

The agency’s consumer protection task force formed in the wake of the virus outbreak is sending warning letters to companies about their allegedly fraudulent products, giving them 48 hours to reply and comply before FDA resorts to enforcement actions – including product seizures or injunctions – or possible referral to the Office of Criminal Investigations. 

This level of warning indicates that “FDA seems to be acting much more quickly than they have in the past,” according to Robert Church, a partner in the Los Angeles office of Hogan & Hartson.

Giving a 48-hour window to take corrective actions “shows that they’re moving pretty quickly over there,” said Church, a former associate chief counsel for drugs in FDA’s Office of the Chief Counsel.

Heartburn Competition Heats Up Worldwide

Two Swiss firms are poised to expand the OTC heartburn remedy market on either side of the Atlantic.       

Nycomed gears up to launch Pantozol Control (pantoprazole 20 mg) later this year with an expected approval for European Union nonprescription marketing authorization. The firm’s proton pump inhibitor is the first to gain an advisory panel’s positive opinion for centralized nonprescription status in the EU.

Meanwhile, Novartis has received FDA approval for OTC sales of the PPI Prevacid 24HR (lansoprazole 15 mg). The company plans to launch in 2009 but says it is waiting until it has adequate inventory to meet consumer demand.

What will these products face in the existing markets, and how will they change  the competetive landscape? Subscribers to “The Tan Sheet” can read about Nycomed’s challenges for marketing Pantozol here and Novartis' strategy for gaining market share here.

As always, subscribe or start a free trial here.

New Kid on the Block

Novartis will bring the first branded competitor to Prilosec OTC to the nonprescription PPI market.

The Tan Sheet gives you the details, below. For much more news and analysis of the OTC market, read the full publication online here.  Not a subscriber? Sign up or get a free trial here.

Prevacid OTC Switch Gets FDA Go-Ahead, Novartis Says

FDA has approved the proton pump inhibitor Prevacid 24HR for OTC sale, Novartis says May 14. The decision marks the first successful Rx-to-OTC switch in the U.S. since Johnson & Johnson’s Zyrtec was approved in November 2007.

Novartis notes delayed-release Prevacid (lansoprazole 15 mg) is the first PPI approved for OTC use in its original Rx formulation. It will join Procter & Gamble’s Prilosec OTC (omeprazole 20 mg) and private-label products on the OTC PPI market.

Why FDA's Cheerios Warning Is Bigger Than You Think

Borrowing a page from the playbook of former commissioner David Kessler, acting FDA chief Josh Sharfstein has slapped a major food firm to get the attention of the whole industry and sent a message that there’s a new sheriff in town.

Specifically, the agency’s warning letter to General Mills that Cheerios’ cholesterol claims as currently worded render it an unapproved drug can be read as a message to all food and dietary supplement manufacturers that make any type of health claims on their products: hew tightly to FDA’s claims regulations and approved language, or else.

This is the agency’s clearest message yet since the administration transition that things are going to work a little differently in the regulated industries than they have over the previous eight years.

General Mills uses a soluble fiber claim the agency approved years ago, but the agency says certain variations in the Cheerios labeling take it over the line.

Read The Tan Sheet’s story, which shows just how particular the agency will be about claims language now (Subcription only).

Observers who followed FDA in the '90s are having flashbacks to the tenure of former Commissioner David Kessler, who sent a message to juice manufacturers that the agency would not tolerate claims that juice made from concentrate was “fresh.” In that case, the agency actually seized product from a big company ­– Procter & Gamble.  Read about it in the New York Times archives here.

While a seizure is clearly a more aggressive move, the strategy is the same: pick a prominent target, and let the whole world know in one stroke that things have changed. And the Cheerios attack also got plenty of headlines and front-page treatment.

As FDA says in its official biography of Kessler:

“Early in his tenure, he took action to protect consumers from misleading uses of the term ‘fresh’ in conjunction with processed or partially processed orange juice and tomato products, gaining himself the nickname ‘Elliot Knessler.’”

We know what you’re wondering. Will the current leadership be able to earn enforcer nicknames that are anywhere near that awkward?

We’ll just have to keep an eye on Josh Harshstein and Peggy “the Grinder” Hamburg.

FDA Will Rev GMP Inspections Of Medium Supplement Firms, After A Pause

Medium-sized dietary supplement firms should not be fooled if FDA gets off to a slow start inspecting for good manufacturing practices compliance, but should expect a marked uptick in the agency's volume of inspections.

Medium-sized firms - firms with 20 to 499 employees - have a June 25 deadline to comply with FDA's GMP final rule.

("The Tan Sheet" also reports that experts say ingredient suppliers have an incentive to comply voluntarily with dietary supplement good manufacturing practices: to stay in business.)

Brad Williams, special assistant to the director at FDA's Division of Dietary Supplement Programs, says inspectors are not likely to come knocking too soon after June 25 because the companies will have only just begun keeping GMP records, leaving limited data to review.

However, inspections will start "within a number of months and then I would expect a fair number," he told industry stakeholders April 30 at the annual SupplySide East tradeshow in Secaucus, N.J.

Williams said the agency's relatively slow pace of GMP inspections during the first year of compliance for large firms, which began June 25, 2008, is no predictor for the coming year.

Informed Pharmacists Can Help Boost OTC Sales

Consumers increasingly prefer the convenience and cost savings of visiting pharmacies instead of primary care providers for general health advice, industry experts say.

Consumer health care product manufacturers and marketers can capitalize on this trend and potentially boost product sales by working with pharmacists to spread the word about their products, said Nicholas Hall, chairman and CEO of Nicholas Hall & Co., at the company’s recent conference in Venice.

Specifically, he suggested firms offer training about their products and the ailments they treat so pharmacists are more confident recommending the product.

Categories that could benefit from pharmacist education include nicotine replacement therapy, emergency contraception, weight-loss and cough and cold products because consumers often seek these products and have conflicting information or feel overwhelmed.

At the very least, Hall said, drug companies should give pharmacists comprehensive merchandising material about their products. Pharmacists can refer to the literature or give it to customers. That way, even if patients do not buy the product when the pharmacist first recommends it, the literature might prompt them to buy it next time they suffer similar symptoms.

To pull this off, firms need to take trade marketing as seriously as consumer marketing.

All too often in product presentations to executives, “when you talk about consumer advertising and show TV ads, you have wide eyes and lots of attention, but when you get to the trade marketing part, the general manager usually visits the bathroom” or stops paying attention, Hall said, adding this disregard for trade marketing “is a pity.”

 

H1N1 Spread Makes Antiviral Market Possible Adulteration Target

Pandemic flu is a “perfect opportunity” for adulterated ingredients or products to reach the market, a pharmaceutical industry executive warned during FDA’s May 1 public meeting on economic adulteration.

“The world is in short supply of antiviral agents – governments all around the world are trying to increase their stockpiles so they can treat their populations,” said Martin Van Trieste, Amgen’s VP for quality and chairman of the Pharmaceutical Research and Manufacturers of America’s Quality Technical Group.

“It’s the perfect opportunity … for someone to come in and make a quick buck. So now knowing that, we must stop, think like criminals, we have to think like the criminal, so that we can prevent what a criminal would do.”

FDA has not warned about adulterated ingredients for antivirals, but the agency and the Federal Trade Commission published a May 1 consumer alert about bogus products marketed to treat or prevent H1N1influenza infection. Additionally, FDA’s incident management structure for responding to the outbreak includes a consumer protection team.

The Centers for Disease Control and Prevention, which posts its latest N1H1 information here, today said the H1N1 outbreaks appears less severe than initially expected, the Washington Post reported here.

“The Tan Sheet” reports here about FDA’s response to the H1N1 virus, including targeting preventing sales of possibly dangerous products fraudulently offered to prevent or treat the flu. Read about federal agencies’ development of a program for home stockpiling of antivirals here, and about consumer demand for hand sanitizers and other products in response to H1N1 here.