HEALTH

West Virginia prescription-only PSE bill passes Senate, heads to House of Delegates

BY Michael Johnsen

CHARLESTON, W.Va. — The West Virginia Senate on Tuesday voted 25-to-9 to make pseudoephedrine a Schedule IV prescription drug and exempt medicines that can’t easily be diverted to methamphetamine, according to published reports. A similar bill is being considered by the West Virginia House of Delegates.

According to reports, the two exceptions to the prescription-only requirement would include Acura Pharmaceuticals’ Nexafed and Westport Pharmaceuticals’ Zephrex-D. 

"It is very disheartening that certain members of the West Virginia legislature are determined to impose higher healthcare costs and onerous burdens on responsible taxpayers in the face of overwhelming evidence that such an approach would fail to address the root causes of the methamphetamine problem," said Carlos Gutierrez, senior director and head of state government affairs for the Consumer Healthcare Products Association. 

"Under a prescription requirement, thousands of West Virginians will have to take time off from work or school, drive to the doctor and pay additional copays at the pharmacy — just to get the nonprescription medicines they rely on to treat common cold and seasonal allergy symptoms. It would be one thing if the costs of these considerable burdens led to significant gains against meth cooks and dealers, but any honest examination of other states that have passed such a policy reveals that meth-related crime remains a vexing problems for law enforcement officials in those states," he said. "We would also urge members of the House of Delegates to consider the fact that West Virginia’s greatest drug threat involves narcotics that already require a prescription."

 

 

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ERSP recommends truDERMA discontinue certain claims supporting Troxyphen

BY Michael Johnsen

NEW YORK — The Electronic Retailing Self-Regulation Program on Tuesday recommended that truDERMA discontinue certain claims for the company’s Troxyphen dietary supplement, including claims that the product is “safe and clinically researched.”

As support for the performance and establishment claims at issue, the marketer submitted testing on its key ingredient. After reviewing the evidence, ERSP concluded that truDERMA provided a reasonable basis for claims relating to an “increased sex drive.”

However, ERSP determined that the marketer did not provide adequate support for claims that Troxyphen will “burn excess fat” or that users will “gain muscle mass.” ERSP recommended that the marketer discontinue any claims of weight and/or fat loss, increased muscle and improved BMI.

ERSP also recommended that the marketer discontinue claims that promise quantified performance results and modify general claims of increased testosterone by disclosing that the product must be used in conjunction with resistance training.

The marketer did not provide evidence indicating that the dosages of ingredients contained in Troxyphen will provide the results specifically stated in the advertising. As a result, ERSP recommended truDERMA discontinue several ingredient claims and the claim that “Troxyphen is safe & clinically researched.”

The company, in its marketer’s statement, said, “truDERMA appreciates ESRC’s comments and direction on our advertising. We are committed to helping people lead healthier, happier lives. truDERMA will give serious consideration to ESRC’s recommendations in our advertising practices.”

ERSP is an investigative unit of the advertising industry’s system of self-regulation and is administered by the Council of Better Business Bureaus. The marketer’s advertising came to the attention of ERSP through an anonymous competitive challenge.

 

 

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Asthma solutions in demand

BY Michael Johnsen

The one-time $100 million asthma-relief brand Primatene may make a comeback to the marketplace after a more than two-year hiatus. Primatene Mist had been withdrawn from the market in December 2011 when the agency removed all inhalers containing chlorofluorocarbons from the market.

The Nonprescription Drugs Advisory Committee will be meeting Feb. 25 to discuss data submitted by Armstrong Pharmaceuticals in support of a new drug application for the over-the-counter marketing of Primatene HFA, an epinephrine inhalation aerosol 125 mcg/actuation, as a temporary reliever of mild symptoms of intermittent asthma for consumers ages 12 years and older.

The demand for an asthma inhaler in the self-care space is there. Nephron Pharmaceuticals has been seeing quite a lift in sales of its Asthmanefrin nasal spray, which reached $17.7 million, up 987%, for the 52 weeks ended Dec. 1 across total U.S. multi-outlets, according to IRI. Asthmanefrin contains racepinephrine USP 11.25 mg, a bronchodilator.

There also are homeopathic solutions that have carved out a niche in the asthma space. At the 2013 NACDS Total Store Expo, Homeolab launched its Real Relief Asthma Nighttime product. Retailing for a suggested $11.99, the homeopathic tablets help relieve symptoms associated with asthma, including gasping for air, difficulty breathing, wheezing, coughing and excess mucus. And homeopathic supplier King Bio in 2012 launched its AsthmaCare homeopathic spray.

According to the Asthma and Allergy Foundation of America, 25 million Americans have asthma.

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