False and Misleading or Just Messy?

When it comes to marketing and promotion, most pharmaceutical companies play by the FDA rules. Violations result in Warning Letters. And Warning Letters are not good. Period.

To avoid such violations, drug companies have introduced promotional review committees and other measures to keep marketers on the straight and narrow.   Additionally, they’ve hired Compliance Officers, regulatory staff and legal counsel.  Now it seems, pharma may have to add house-keeping to the mix!

Last summer, NeurogesX, a San Francisco-based biopharmaceutical company exhibited at the American Academy of Nurse Practitioners meeting in Las Vegas to promote Qutenza  – a capcaisin treatment for neuropathic pain associated with postherpetic neuralgia; a condition that occurs as a result of nerve damage after an outbreak of shingles.

The NeurogesX exhibit included an eye-catching promotional panel for Qutenza featuring a polar bear. The panel made various effectiveness claims, and included all the risk and safety claims required by the FDA.  So, what’s the problem?

Well, according to a Warning Letter sent to the company the risk information was inaccessible to those who stopped or walked by because it was obscured by bags, boxes and other stuff! As a result, the FDA deemed the entire booth to be false or misleading.

How did the FDA know? Well, apparently three different personnel from the FDA Office of Prescription Drug Promotion, visited the booth separately at three different times, meaning this was not a one-off occurrence.

So, was this a simple case of carelessness or was NeurogesX trying to hide the risk information? I’m not sure we’ll ever know the truth, but it’s clear the FDA is “cleaning house” – one exhibit booth at a time.

Was the Agency justified?  If they really care about safety why didn’t they say something at the time, rather than let the boxes obscure the data throughout the show?  Let us know what you think.

A Big “Clap” for the FDA

Sexually transmitted diseases (STDs) have always been a bit of a taboo subject.  Especially it seems among the FDA.   In a joint initiative with the Federal Trade Commission (FTC), the Agency has just sent warning letters to more than a dozen companies selling non-prescription products that claim to treat STD’s such as herpes, chlamydia, genital warts, HIV, and AIDS.

Despite names such as Medavir, Herpaflor, Never An Outbreak and C-Cure, the FDA says that none of the products have been proven to prevent, treat or cure any disease.  In fact, say FDA scientists, the products are a public health hazard because patients could waste time taking them and delay seeking medical care.

A full list of the companies and products involved can be found here.

These products, sold both online and in retail outlets, often claim to be supported by research. A website for Medavir, made claims the product “has been proven effective in several official university research studies, including an official FDA trial.”

Similarly, Arenvy Laboratories’ website for ImmuneGlory touts the product as “the ultimate herpes outbreak solution” and claims the product “strengthens your immune system so that herpes or cold sores have nowhere to hide.”

However, the Agency says that is has never approved any non-prescription products for sexually transmitted diseases.  Drugs are available for herpes, chlamydia, HIV and other diseases, but only via prescription.

These products are dangerous because they are targeted to patients with serious conditions, where treatment options proven to be safe and effective are available,” said Deborah Autor, FDA Director of Drug Compliance.

Companies cited by the FDA will have 15 days to take their products off the market. If they do not, the agency can take legal action, including seizing products and taking company officials to court.

Additionally, under the FTC Act it is illegal to make such unsubstantiated treatment claims.

These companies are on notice that advertising health benefits that are not supported by rigorous scientific evidence violates the FTC Act,” said David Vladeck, Director of the FTC’s Bureau of Consumer Protection. “They also should know that health scams that endanger public health will not be tolerated.”

While we wait with baited breath to see if the companies will comply, Word on Health cautions its readers that appropriate treatment of STDs can only occur under the supervision of a health care professional.

Watch Out – the FDA’s About!

It’s been a busy year for the FDA.  In addition to approving 63 new and original drug applications (NDA’s and BLA’s)  since the beginning of 2010, the Agency has rejected countless more, including the much touted “pink pill” or Female Viagra and the fat fighting drug Qnexa.

They also appear to have taken on the pharmaceutical industry – in a big way.

Industry insiders and observers are all acutely aware of the increase in the number of Warning Letters and Notice of Violation letters coming out of the FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC).

Since January 2010, DDMAC has issued 71 warning letters, notifying pharmaceutical companies about promotional violations. The number has been steadily rising since 2009.

Word on Health suspects that this may, in part, be due to the fact that the FDA recently reversed a policy that required warning letters to undergo legal review before they were issued. Then again, maybe the Agency’s BadAd program is bringing more promotional “no-no’s” to their attention.

Others would like to blame social media and the lack of FDA guidance for the increase. Indeed, just last week the FDA issued a Notice of Violation letter regarding the “Share” function on Facebook.  It’s also rumored that DDMAC has staffed up.

Whatever the reason, it means the pharmaceutical industry needs to be more careful than ever.

SRxA can help companies develop and deliver, compliant and effect programs. Contact us today to learn how we can help you avoid becoming another FDA statistic.