OTCs in Action Episode 32: ED in NZ, not .com

OTCinActionheaderIllegal internet sales of Rx and OTC drugs, as well as adulterated dietary supplements, put consumers at great risk. “Tainted Sexual Enhancement Products”, published on the FDA’s website, warns consumers:

“The FDA has identified an emerging trend where over-the-counter products, frequently represented as dietary supplements, contain hidden active ingredients that could be harmful. Consumers may unknowingly take products laced with varying quantities of approved prescription drug ingredients, controlled substances, and untested and unstudied pharmaceutically active ingredients. These deceptive products can harm you! Hidden ingredients are increasingly becoming a problem in products promoted for sexual enhancement. Remember, FDA cannot test all products on the market that contain potentially harmful hidden ingredients. Enforcement actions and consumer advisories for tainted products only cover a small fraction of the tainted over-the-counter products on the market.”

Last week, this blog’s sister publication, OTC.NewDirections, reported that an international crackdown on  illegal internet trade of medical products yielded $81.8mn worth of items from 115 different countries, and 156 arrests. In the UK, a record $25.1mn worth of counterfeit and unlicensed medicines and 15,000 devices was seized, including potentially harmful slimming pills, erectile dysfunction, anaemia and narcolepsy tablets. The US FDA took action against 1,050+ websites that illegally sell potentially dangerous, unapproved Rx medicines and medical devices.

In fact, regulators around the world are playing a high stakes game of Whack-a-Mole, a popular arcade game in which players hit cheeky little moles with mallets, but as soon as one is knocked out another appears elsewhere.

WHACK A MOLE_0However, the risky business is driven by consumer demand, and now OTCs are in Action in New Zealand to satisfy those needs safely and legally. One of the more common unapproved ingredients in the FDA’s list of adulterated products is sildenafil, more commonly known by its legal Rx brand name, Viagra. The Rx-to-OTC switch of Silvasta (sildenafil) erectile dysfunction treatment in New Zealand was approved in late 2014. Men aged 35-70 years can purchase Silvasta without an Rx following a screening process with a trained pharmacist. This spring Nicholas Hall & Company awarded Douglas Pharma its top marketing award for the launch of Silvasta. A consumer campaign includes TV ads featuring an “everyday” man explaining that help is at hand from pharmacies without the need to see a doctor, while a pharmacy finder website directs men to the nearest outlet.

Another interesting development that will ensure consumer access to safer drugs is the UK’s new requirement that online medicine sellers must be registered with the Medicines & Healthcare products Regulatory Agency. They must display on every page of their website the new European common logo, which will be linked to their entry in the MHRA’s list of registered online sellers. The medicine being offered online must be licensed in the member state where the purchaser is based, and the seller must be legally entitled to sell medicine in accordance with UK legislation. Registered pharmacies can sell general sales list and pharmacy medicines or supply Rx-only medicines that they have dispensed against a prescription. Other retailers can only sell GSL (self-selection OTC) products. The penalty for disobeying the registration and logo rules is up to two years in prison, a fine or both.

In an somewhat related matter, as it affects consumer safety and appropriate use of OTC medicines by reducing illicit methamphetamine manufacture, Acura Pharmaceuticals has entered into an agreement with OTC cold remedy giant Bayer to license its IMPEDE technology. IMPEDE technology, which is available in the US in Acura’s Nexafed, has demonstrated significantly reduced yields of methamphetamine compared to traditional formulations in lab tests and has been associated with a reduction in meth labs in local markets of up to 90%. OTCs in Action covered the launch of Acura’s Nexafed Sinus Pressure + Pain (pseudoephedrine and acetaminophen) in February.

Episode 17: Outwitting meth manufacturers

OTCs in Action Episode 12: Science uncovering life-extending benefits

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OTC.Newsflash reported that the global community is living longer – by about 6 years to 71.5 in 2013 compared to 1990’s life expectancy. The Global Burden of Disease Study 2013, published in The Lancet, indicates that improvements in healthcare have prompted dramatic shifts, including a major reduction in child mortality from diarrhoea and lower respiratory infections. However, death rates from many types of cancer, as well as lifestyle-influenced, chronic diseases such as diabetes and heart disease, have increased.

Can OTCs be part of the solution? In the past year, Nicholas Hall’s OTC.NewDirections has kept us up to date on the OTC scientific developments that are a significant factor in the preventive and therapeutic advances that are extending lives. In the most recent issue, we read about how vitamin E can protect older mice from pneumonia, creatine may improve blood pressure, selenium might lower the risk of colorectal cancer and NSAIDs might reduce the risk of skin cancer.

Because of their safety profile, accessibility and affordability, the importance of OTCs is often understated – they don’t often grab the headlines in mass media or corporate financial reports. But to families around the globe, OTCs are in Action improving lives everyday by treating acute illnesses, and increasingly, preventing chronic disease.

Best wishes for a healthy New Year!

OTC.Newsflash and OTC.NewDirections e-mail bulletins are published weekly by Nicholas Hall & Company.

 

 

 

 

Nicholas Hall’s OTC.NewDirections: FDA rulings in Medical Devices and Dietary Supplements

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Two areas we focus on in our latest OTC.NewDirections bulletin are new regulations for dietary supplements and medical devices. In Canada, quality assurance measures are being introduced for Natural Health Products, while across the border in the US, the FDA has issued guidance to help marketers distinguish between liquid dietary supplements and beverages.

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OTC NewDirections Welcomes you to 2014

NDNWEditorsHeadersThe latest Newsletter from Co-Editor on OTC.NewDirections, Nicola Watts.

OTC.NewDirections, welcomes you to 2014 with the first bulletin of the year, where we are looking at the latest in clinical trial data transparency. The UK government has said it is “surprised and concerned” that data is routinely withheld from the medical and academic community. Meanwhile, a provisional agreement between the European Parliament and Council of Ministers would require both Pharmaceutical companies and academic researchers to upload all their results to a publicly accessible database. Continue reading