Topic1: Proactivity vs. Risk- Subject to Interpretations

How can so many sophisticated organizations with access to piles of lawyers have such different interpretations?  The answer is that the regulations themselves are less than clear in terms of pharma’s rights and limitations in terms of scientific outreach and education.

Here is a great reference page with most of the important regulations from the FDA web site:

http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm109905.htm

Looking at things in terms of the MA Proactivity Spectrum discussed in the previous post, we see the following:

Disease State Proactivity

There is not approved guidance in this area yet, but here we have available a draft guideance:

"Help-Seeking" and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms*DRAFT*(Issued 1/26/2004, Posted 2/4/2004)

Per the draft guidance, disease state education aimed at HCPs that does not mention and not make any suggestion concerning a particular drug is not considered advertising and thus not subject to advertising restrictions.  There are many details behind this but this is a good starting point.  Even here, with a direct guidance (draft), there are still areas of uncertainty as the Agency can take a different perspective based on the number of drugs or treatment options available.

Supportive Information for Existing Label

In this case, the most directly related regulations are those associated with the original FD&C and related comments since this is essentially discussions of an approved drug:

Federal Food, Drug and Cosmetic Act

Chapter II - Definitions (Sec. 201 [321] (g)(1), (k), (m), (n), & (p))

Chapter III - Prohibited Acts and Penalties (Secs. 301 [331], 302 [332], 303 [333], & 304 [334])

Chapter V - Drugs and Devices (Sec. 502. [352] (a), (e), (f), & (n))

And,

Code of Federal Regulations

The following links go to the Government Printing Office web site.

21 CFR 99 - Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices

Unapproved Use

In 21 CFR 312.7(a) we can see that  FDA regulation restricting promotion of investigational new drugs provides that a manufacturer may “disseminat[e] . . . scientific findings in scientific or lay media” without engaging in promotional activity, but promotional claims of safety or effectiveness for a use for which the product is under investigation are subject to FDA regulation as advertising or labeling.

Hence the draft guidance available:

Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices*DRAFT* (Posted 12/27/2011)

Closing Thought

Clearly there is a lot to consider but the most important takeaway is the understanding that these regulations are subject to interpretations when you consider MA’s role in pharma, thus the need for an effective compliance department and the “room” for the MA Proactivity Spectrum.

What do you think?  Leave a comment below.

Legal Note:  All information and interpretations presented are only the opinion of the author(s) who are not lawyers. And, even if we were lawyers, given the wide range of interpretations of the current regulations you would still need to get the input from your own compliance organization.  Simply put – your mileage may vary.