A Look Back at Regulatory Enforcement by Therapeutic Category

In past years, I have always provided quarterly updates of the Warning and Untitled Letters that the Office of Prescription Drug Promotion (formerly DDMAC) puts out, regulating the promotion of pharmaceutical products. However, with only one letter issued each month so far this year through August – and none posted for September or October, enforcement appears at a near standstill. It seemed like a good time to look back at past letters in the aggregate for some insights.

Keeping all of the letters in a database that is regularly updated allows me to sort on a number of fields. Fields tracked include the type of communications vehicle (digital or non-digital), the specific communications vehicle (brochure, website) and pertinent to this posting, the treatment area for the indication, among other things. This accumulation not only provides perspective – but it also a great source to use as a training tool.

The Warning/Untitled letter database spans back through 2004 (inclusive) and covers the contents of 307 letters which address communications carried by pharma companies in over 400 different communications vehicles (sometimes a letter will address violations across more than one communications vehicle produced by a company). The total number of violations over that period of time is nearly 1100.

I thought that a good place to start in a retrospective might be whether or not therapeutic categories stand out in any way from one another.

And the answer is yes. If for no other reason than by volume.

Treatment areas are broadly categorized as follows:

  • Antiviral/Antimicrobial
  • CKD/Renal
  • CNS
  • Cardiovascular
  • Dermatologic
  • Endo/Metabolic
  • Gastrointestinal
  • Imaging Agents
  • Oncology
  • Ophthalmic
  • Pain
  • Pulmonary
  • Reproductive
  • Urologic
  • Other

As you can see CNS is a big category involving the treatment of a broad spectrum of conditions, including depression, Alzheimer’s, schizophrenia, bipolar, ADHD, smoking cessation products and others. While CNS would normally include Pain – Pain is such a large sub-category that it is backed out and made its own for these purposes. Oncology spanned all types of cancers. Cardiovascular included treatments for hypertension, cholesterol, blood thinners and related conditions. And AntiInfective includes antivirals such as HIV medications, hepatitis and herpes as well as antibiotics and antifungals. (Note sub-categories can also be sorted so that one can look only at HIV-related issues.)

Looking back to all the letters over the years, what we see is that those drugs in the CNS area garnered by far the most letters (58), probably mainly due to the fact that the category is so broad and varied in terms of products (not implying that CNS is a riskier area – the numbers alone don’t tell that story).

It was also interesting that the pain category, while fourth in total letter volume overall, had a very large proportion of its letters coming in the form of a Warning Letter (represented in red), as did Dermatology. This perhaps indicates that when it comes to the these particular categories there may be an argument for taking extra care in devising communications – or at least being highly conversant with the circumstances by which other pain and derma meds have received letters. By contrast, the lowest proportion of Warning Letters went to Endocrinologic (which includes diabetes, osteoporisis) were only 2 out of 11 letters were Warning Letters.

On average, the percentage of violations overall cited in Warning Letters across all treatment areas was about 25 percent). The treatment areas that had proportions of Warning Letters higher than that included Anti-Infective, Cardiovascular, Dermatological (nearly half!), Gastrointestinal, Pain and Pulmonary. Surprisingly, CNS – with its many black box warning labels – and Oncology were below the average.

The real value comes in characterizing the reasons for violations in these categories. But it is clear, not all therapeutic categories are equal.

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