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Report: Pfizer said to seek OTC switch for Lipitor

BY Alaric DeArment

NEW YORK — The world’s top-selling drug may become available over the counter, if its manufacturer has its way, according to published reports.

The New York Times reported that Pfizer may be looking for Food and Drug Administration approval for an OTC switch for Lipitor (atorvastatin calcium), a cholesterol-lowering medication. The Times quoted an unnamed source as providing the information, though Pfizer declined to comment.

Lipitor is the world’s top-selling drug, with annual sales of more than $7 billion in the United States alone, according to IMS Health. But it’s set to lose patent protection this year and face competition from cheaper generic versions. An OTC switch would allow Pfizer to continue profiting from the drug even if sales of the prescription version took a dip.

But the going won’t be easy. While Rx-to-OTC switches for drugs to treat allergies and heartburn generally have been successful, switches for statins haven’t been. In 2008, the FDA declined to allow an OTC switch for Merck’s Mevacor Daily (lovastatin) due to issues with patient self-selection that emerged during clinical trials; some patients taking prescription-strength statins had reported that they would be willing to switch to the weaker Mevacor Daily, thus putting themselves at risk of being inadequately protected against heart disease. Other patients had misconceptions about Mevacor Daily, thinking it would be more appropriate because it was cheaper and that it would have fewer side effects, with half of patients already taking a statin saying they would switch to OTC Mevacor due to cost concerns.

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B.MAY says:
Aug-09-2011 11:41 am

I do not think the switch to OTC status is a good idea. As with the Mevacor attempt, the potential for undermedication and cardiac risk is too great. In addition there is potential for untoward drug interactions.

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NAD challenges respiratory-relief claims made by Nu Century Herbs for its supplement Resprin

BY Michael Johnsen

NEW YORK — The National Advertising Division of the Council of Better Business Bureaus on Thursday recommended that Nu Century Herbs discontinue certain disease-state claims promoting the company’s Resprin dietary supplement.
 
NAD requested substantiation from Nu Century for claims made in Internet advertising, including: 

  • “The natural solutions for your asthma/allergy customers growing healthcare concerns;”

  • “Clinically shown to support upper respiratory health and clearer, easier breathing;” and

  • “This natural herbal breathing enhancer is specially formulated with a unique blend of 23 herbs, clinically shown to support respiratory health and clearer breathing.”

In addition to the specific claims above, the Council for Responsible Nutrition raised a concern over the consumer testimonials on the advertiser’s website.

The advertiser, upon receipt of NAD’s inquiry, informed NAD that it had permanently discontinued claims that state Respirin is “clinically shown” to produce any health benefit. Further, the advertiser asserted that it had discontinued all claims that reference specific diseases, including asthma and allergies, claims at the company’s website that reference “clinical support” and all testimonials.
 
NAD reviewed evidence indicating the ingredients in Respirin have been recognized and used in traditional Chinese medicine for lung health and considered the report of a TCM expert who concluded that “… there is sufficient support from a TCM perspective to support the use of Resprin as a formula to assist people with breathing difficulties.”
 
NAD concluded that the advertiser provided a reasonable basis for certain claims based on TCM for the ingredients in Resprin, to the extent they are clearly stated as such, in accordance with the Federal Trade Commission Guides, i.e., “[claims] based on historical or traditional use should be substantiated by confirming scientific evidence, or should be presented in such a way that consumers understand that the sole basis for the claim is a history of use of the product for a particular purpose.”
 
In this case, however, the advertiser maintained it could support its advertising claims independently of the TCM based evidence. NAD disagreed.
 
NAD recommended that the advertiser discontinue certain claims that go beyond TCM-based evidence, including claims that Resprin can “naturally enhance your breathing;” is “the natural way to clearer breathing;” or will help one “breathe easier.”
 
"Nu Century accepts the conclusions and the recommendations of NAD in its final case decision," the company stated. "Accordingly, Nu Century agrees to take these recommendations into account in the language of its future advertising."

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NACDS, NCPA ask FTC to just say no to Express Scripts-Medco merger

BY Michael Johnsen

ALEXANDRIA, Va. — The National Association of Chain Drug Stores and the National Community Pharmacists Association on Thursday delivered their first formal letter to the U.S. Federal Trade Commission in shared opposition to the proposed merger of Express Scripts and Medco Health Solutions.

The initial correspondence emphasized joint opposition to the proposed merger on the grounds of the merger’s anticompetitive impact on patients, consumers, the market and the entire healthcare delivery system.

The joint NACDS/NCPA letter can be read here.

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