Big Brother may not be watching, but the FDA, it seems is!

Here at SRxA, we all know how much physicians like to put on their marketing hats. In future, it seems, they might have to reach for their safety helmets instead!

According to our fellow bloggers at Good Promotional Practices doctors are starting to be held accountable to the same promotional compliance standards as pharmaceutical companies.

As most of our readers know, when FDA approves a drug it does so for a given use or indication. However, physicians are still free to make their own decisions based on how a device is used based on their best judgment. When a drug, biologic, or medical device is used for some indication other than the one approved by the FDA it is said to be “off-label.”

In this almost perfect dichotomy, it is perfectly legal, in the United States, for a physician to use a drug or device for “off-label” but it is unlawful to market, advertise or otherwise promote the off label use of a device or drug. Furthermore, based on the flurry of DOJ, OIG and FDA activity, such as the massive fines leveled out to Allergan ($600M), GlaxoSmithKline ($750 M), Novartis ($422 M) and Pfizer (2.3 billion) companies must keep the practices of their marketing and sales department in check to ensure compliance.

Until now the “it is unlawful to market, advertise or otherwise promote off label use of a drug” has been aimed at Pharmaceutical companies and third parties acting on their behalf.  Now people are asking “What if the hospital or physician group is doing the marketing themselves, not the company?

We’ve all seen the billboards and free in-flight magazine ads promoting the latest medical treatments from liposuction to joint and hormone replacement.  With physicians are competing harder than ever to bring patients to their doors, what’s to stop them from stepping over the same lines that the companies may have, either willingly or not?

Blogger Sean McCarthy uses the example of the irregular heart rhythm Atrial Fibrillation (AF, AFib).  While there are very few approved drugs or devices to treat atrial fibrillation, upwards of 2.5 million Americans suffer from this debilitating condition.  Not so surprising then, that physicians use an array of off-label drugs and devices to treat this disease. So, now the hospital or physician communicates their ability to help AFib patients by promoting their latest treatment for the disease on a billboard or newspaper article. Isn’t this the same thing as a company promoting off-label use?

State Attorney Generals, the DOJ and FDA must be taking notice. They drive by the same billboards we do and read the same newspapers.  McCarthy says he’s heard rumors of a state Attorney General investigating a doctor about his referral patterns and advertising activities.

Who better than the pharmaceutical industry to take the lead in providing education to physicians  to help them prevent compliance snafus.  After all we’ve been there, done this!

Contact SRxA today to see how we can get you started.

Eye Injection that could save the sight of the over 30’s

We’re not telling you how old we are…but SRxA’s Word on Health was thrilled to hear about a new injection that can prevent people over the age of 30 from losing their sight.

The FDA approved drug Ozurdex (dexamethasone intravitreal implant) is the first effective treatment of macular edema following either branch or central Retinal Vein Occlusion (RVO), a disease that affects one in 200 people over the age of 30. The condition is caused by a blockage in the veins that take blood away from the retina.

Sufferers suddenly notice the vision in one eye has become blurred or distorted.

Controlled clinical studies have shown that Ozurdex can reduce swelling at the back of the eye.  By reducing macular edema, it  may help reverse some of the vision loss due to retinal vein occlusion. A third of patients experienced a significant improvement in their vision within 2 months of the injections, compared with only 7% of patients who received a placebo injection.

The Orudex implant is injected into the eye through a small needle. During the procedure patients are awake. According to the manufacturer, the injection is generally well tolerated and is over in seconds. The Ozurdex capsule is just 6mm long and releases the active ingredient over a period of six months before harmlessly degrading.

In the US, the drug is indicated for treatment branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO).

After receiving Ozurdex, patients can typically see an extra three lines on an eye chart.  Ian Pearce, a consultant ophthalmologist of The Royal Liverpool University Hospital, said “The evidence is that 30% of patients might get that benefit. It’s very significant. This drug could make the difference between driving and not driving, reading and not reading.”

Here at Word on Health, we’ll certainly be keeping our eye out for it!

Something to Smile about

SRxA‘s Word on Health broke out a wrinkle-free smile at the news that Allergan’s Botox sales have increased 5.6% over the last quarter.  Sales of the popular cosmetic injections have been declining during the past few quarters mainly due to weak consumer spending and increased competition.

Going forward,  Allergan is looking to grow Botox sales further by gaining approval for additional indications. The company has recently filed for FDA approval of Botox for the treatment of chronic migraine.

SRxA‘s Word on Health hopes this news not only relieves headaches but also  heralds an  upturn in the economy.