OverTheCounterToday

FDA, DEA Bear Brunt Of Specter's Wrath Over Steroid "Supplements"

In the wake of yesterday's Senate hearing on "hidden steroids" sold as dietary supplements, mainstream media outlets are focusing on possible efforts to amend the Dietary Supplement Health and Education Act.

The New York Times notes here that Congress is investigating "whether laws, health agency resources and manufacturing guidelines are adequate to protect the public from products that illegally contain steroids but masquerade as dietary supplements." Meanwhile, the San Francisco Chronicle reports that Sens. Orrin Hatch and Arlen Specter, the only lawmakers present at the hearing, "voiced uncertainty" about the need for changing DSHEA.

McClatchy focuses here on FDA's supposed difficulty in keeping tabs on the dietary supplement market. At the hearing, Michael Levy of the Office of Compliance in the agency's drug center discussed the challenge of identifying and analyzing violative steroid products, but did not request more agency authority over supplements.

Actually, "The Tan Sheet" believes FDA and the Drug Enforcement Administraiton took the most heat from Specter, while the supplement industry was generally spared. The Pennsylvania Democrat, who chairs the Judiciary Subcommittee on Crime and Drugs, once again engaged in the cherished congressional pasttime of bureaucracy bashing.

Monday OTC/Nutritional Chatter

Note: This post has been corrected to reflect that Sen. Schumer was comparing his experience with simvastatin, a generic version of the branded statin Zocor, to branded Lipitor (atorvastatin).

Here's what we're talking about around the water cooler as the third quarter wraps up and fall kicks into high gear...

Sen. Grassley plugs supplement benefits during Finance Committee health care reform bill markup...

Schering-Plough CEO Hassan praises his firm's OTC business as Merck merger nears closure...

Commissioner Hamburg talks food, tobacco, devices on public radio...

Sen. Specter hosts supplement interests, opponents for hearing on "hidden steroids"...

OTC Prevacid On Shelves In Time For Thanksgiving Heartburn?

Novartis says its over-the-counter Prevacid 24HR could be available as early as Nov. 12, according to a two-page advertisement in the Oct. 23 issue of All You magazine. 

The company has also updated www.prevacid24hr.com with product packaging, drug facts and a frequently-asked-questions section regarding the proton pump inhibitor, which Novartis licenses from Takeda Pharmaceuticals.

As "The Tan Sheet" reported in May upon the product's OTC switch approval, Prevacid 24HR (lansoprazole 15 mg) appears to be going after the subset of Rx PPI patients suffering from frequent heartburn, rather than targeting users of Procter & Gamble's Prilosec OTC (omeprazole 20 mg).

The Web site offers consumers a value proposition, telling them, "With Prevacid24HR you could save time and money. You may save up to 20-40% over a leading brand of prescription frequent heartburn medication. And think of the added convenience -- you'll be able to find Prevacid24HR at your local retail store or online."

OTC And Nutritionals Business News Roundup

In today's roundup...

Atrium Acquires Garden Of Life, Gains Distribution To Health Food Stores: Atrium Innovations' $35 million acquisition of supplement marketer Garden of Life secures the Canadian firm a strong foothold in the health food store distribution channel and expands its U.S. presence.

Dannon Not Immune To Class Action Objections To Health Claims: The yogurt giant agrees to alter labeling and marketing for Activia and DanActive products, in addition to paying up to $35 million in consumer redress.

FDA To Host Discussion On Future Of OTC Asthma Inhaler: The agency's drug center will hear from industry stakeholders, asthma experts and consumers on strategies for shifting the market and patients away from epinephrine inhalers that use chlorfluorocarbons.

OTC Tax Exemptions At Risk In Health Care Reform

As debate continues over health care reform legislation, over-the-counter drug interests are fighting provisions that effectively would take away tax incentives for the purchase of OTC drugs. We've provided a version of "The Tan Sheet" coverage below. Read our latest issue here or sign up for a free trial or subscription here.

OTCs Lose Health Savings Account Eligibility In Baucus Health Care Draft

Over-the-counter drugs would not be eligible for health savings account reimbursement without a doctor's prescription, under a provision of the health care reform bill draft released Sept. 16 by the Senate Finance Committee.

FDA Emphasizes Need For Food Safety Reform

Top FDA officials highlighted food safety reform at industry conferences this week at a time when the ongoing health care reform debate threatens to overshadow it.

FDA Principal Deputy Commissioner Josh Sharfstein stressed the need for a prevention-based food safety program that includes a hazard analysis and critical control point system to identify and address potential risks.

"We are looking to Congress for authority to apply HACCP plans and change our approach to inspection" to focus on firms' HACCP plans, "and not just inspect after problems have already been identified," Sharfstein said Sept. 14 at the Parenteral Drug Association/FDA Joint Regulatory Conference in Washington. (Read more conference coverage at "The Tan Sheet".)

The House passed the Food Safety Enhancement Act with HACCP-like provisions July 29, but the Senate has not moved its food safety bill out of committee. Sen. Tom Harkin, D-Iowa, who chairs the Health, Education, Labor and Pensions Committee says moving food legislation is a priority.

Neither bill says whether HACCP provisions would apply to supplements, which already must meet the FDA's supplement good manufacturing practices that go into full effect by June 2010.

FDA Commissioner Margaret Hamburg said Sept. 16 at the Regulatory Affairs Professionals Society Annual Conference & Exhibition in Philadelphia that she hopes the Senate will pass the bill soon.

Highway To Smell

As if the threat of pandemic flu hasn't done enough for hand sanitizer sales, one purported treatment could have consumers doubling up on Purell: A Chinese herb known as "dung of the devil" because of its rank smell was found effective against the H1N1 flu virus in a recent study.

Extracts from roots of Ferula assafoetida plants were stronger against the H1N1 swine virus in lab tests than the prescription anti-viral medicine amantadine, according to researchers at Kausiung Medical University in Taiwan.

Amantadine may be a straw man in this study, however, given that it has shown decreasing efficacy against seasonal flu in recent years and does not appear to be recommended for use against swine flu. 

Bloomberg reported here that the research team wrote in a study scheduled for publication Sept. 25 in the Journal of Natural Products that compounds from the plant “may serve as promising lead components for new drug development against" H1N1 infection.

Could it be only a matter of time before FDA issues warnings to online marketers of "dung of the devil supplements" for curing swine flu? The agency certainly already has its hands full with products making dubious antiviral claims, especially so-called supplements, which are compiled here. FDA has been telling companies to immediately cease marketing the fraudulent products and gives them 48 hours to remedy the situation.

Harkin Climbs Into HELP Driver's Seat

Wellness and prevention could play a bigger role in the health care reform debate as supplement industry champion Sen. Tom Harkin takes the helm on the Senate Health, Education, Labor and Pensions Committee.

Harkin announced Sept. 9 he would become chairman of the committee at the front of the Senate's efforts on health care reform legislation and that also addresses FDA's performance and policies on an ongoing basis.

Dietary supplement industry stakeholders may breathe easier knowing an industry champion is taking the leading role on HELP. As "The Tan Sheet" reported here, the Iowa Democrat has said he will defend the Dietary Supplement Health and Education Act against amendments that could put greater restrictions on the products. Along with Utah Republican Orrin Hatch cosponsored DSHEA in 1994.

Adulteration Punches Persist For Supplement Industry

The dietary supplement industry's image takes it on the chin again in recent news stories that question whether manufacturers effectively safeguard their products from adulteration with unapproved pharmaceutical ingredients.

The Washington Post reports here that world champion swimmer Jessica Hardy's suspension from competition was lifted after a U.S. Anti-Doping Agency arbitration panel agreed Hardy's positive test for clenbuterol, an Rx drug ingredient that can increase lung capacity and is on the International Olympic Committee's list of banned substances, was caused by a contaminated supplement.

"The Tan Sheet" reported here that Hardy filed a negligence and product liability claim against the supplement manufacturer, AdvoCare, after she lost her spot on the 2008 U.S. Olympic team due to the test showing clenbuterol in her system, but the Carrollton, Texas-based firm accused Hardy of defamation and "irreparably" harming its business.

Elite athletes are not alone in complaining about supplement ingredients. The Wall Street Journal reports here that a Fraser, Mich., police officer, felt exhausted and suffered chronic, painful itching after using a supplement to facilitate an exercise regimen. A liver specialist linked a steroid on the pills' ingredients list to the liver damage that mainly caused the man's symptoms.

Claritin 12-Hour Aims At Shorter-Duration Allergy Drugs

Schering-Plough extends the Claritin line into the 12-hour allergy relief niche in an effort to go after first-generation antihistamines with shorter durations.

The company announced Sept. 1 the launch of Claritin 12-Hour RediTabs, calling it "the only 12-hour allergy medicine found in the allergy aisle."

Other 12-hour oral remedies for allergies, including Claritin-D 12-Hour, contain pseudoephedrine and must be sold from behind store counters.

Schering's initial marketing for Claritin 12-Hour goes after allergy drugs that offer smaller windows of relief, including Johnson & Johnson's Benadryl (diphenhydramine) and Tylenol Allergy line, which includes diphenhydramine and chlorpheniramine.