About six weeks ago, the FDA set precedence when they took
action against a dietary supplement maker that used Facebook to “Like” an
unapproved claim regarding one of its products.
In this Warning Letter, FDA cited a multitude of serious violations
against the marketer of a drug product called Poly-MVA. The company had sold
its product through the use of testimonials that were not substantiated by good
science, according to FDA.
Just one week prior to this, the FDA issued a warning letter
to a drug maker over that company’s use of a search bar on its web site. The
FDA faulted the firm for improperly linking disease queries directly with drugs
that the company marketed.
The FDA has historically been reluctant to publish clear
guidance when it comes to how it regulates promotion. With the speed of the web, must they adapt
their traditional governing principals?
If they have plans to regulate Internet Pharmacies starting with
promotion regulations, what’s next?
Going back a few months to October 2012, we noted a new FDA
campaign - “BeSafeRx - Know your Online Pharmacy". The FDA BeSafeRx is a national campaign to
raise awareness of the dangers of buying prescription medicines from fake
online pharmacies. This campaign provides the resources to help consumers: (1)
Know the Risks - Learn the Dangers of Buying from an Online Pharmacy (2) Know
the Signs - Identify the Signs of a Fake Online Pharmacy (3) Know your Online
Pharmacy - Find a Safe Online Pharmacy.
Was this the first hint of regulation by establishing a consumer
baseline of sorts?
There is no question that the FDA is seeking to keep up with
the demands and fast-paceness of the digital age with the goal of protecting
consumers. However, the warning letters
are just the start. Also, look for
external guidance for third-party organizations such as the Alliance for Safe
Online Pharmacies (ASOP).
In my option, Online Pharmacies should take proactive action
in protecting themselves. This includes
keeping extremely current with forthcoming guidance from the FDA. There will probably be more of these types of
warning letters in the near future.
Online pharmacies should operate within this guidance and have the
Standard Operating Procedures in place and documented. In terms of Social Media, this means creating
more private networks that are less than ‘socialable’ (just to be safe). In efforts to offset this regulation by the
FDA, online Pharmacies should also familiarize themselves with the manufacturers
promotion of such items as their advertisements are heavily regulated. Internet Pharmacies can also take note from
the Pharmaceutical, Clinical and related drug development industries. These very tight regulations will likely
trickle down in various forms, particularly the regulations related to consumer
promotion.
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