The Way of the Regulator by ProQuest


The minimal strategy," writes Nostrapharmus, "includes assessments, a medication guide or a patient package insert and a communication plan. Since the adoption of FDAAA, a REMS has increasingly been required for product approval, and it is anticipated that requests for post -market REMS will increase with time. With medical devices, it is anticipated that the Center for Devices and Radiological Health (CDRH) may begin demonstrating REMS-like powers in monitoring device risk.

More Info
									                                                                                                       from the editor                05

The Way
of the
Applying pharmaceutical principles now could pave the way to a risk-free future, says Dr Kevin Robinson

           or those of you who may not receive     Devices and Radiological Health (CDRH)           cosmetics and medical devices suggests
           our sister publication, Pharma (www.    may begin demonstrating REMS-like powers         that the industry must proactively address
 , which serves the       in monitoring device risk. While OTC drugs       requirements when preparing a product for
           bio/pharmaceutical manufacturing and    have been subject to the same reporting          market.” Perhaps the most eyebrow raising
life science industries, I thought I’d take this   requirements in the EU as prescription drugs,    thing to note is that the COLIPA regulations
opportunity to pass on some of the information     differences did persist in the US. With the      would bring AE awareness and reporting
that was published in the January/February 2009    passage of the Dietary Supplement and            to an entire industry in which the major
issue, in the regular Nostrapharmus column. The    Nonprescription Drug Consumer Protection         players — you — do not currently have
editorial highlighted the fact that both the US    Act, however, US law now mandates Adverse        pharmacovigilance procedures in place.
and EU have demonstrated an increased focus        Event (AE) reporting for post-marketing             On the topic of regulation, and having shone
on risk-based product evaluation and reporting     serious adverse events associated with           a bright light on globesity in the last issue
with some recent regulatory amendments; the        non-prescription OTC human drug products         of NBT, the Food Standards Agency (FSA)
US has done so most notably with the Food          marketed without an approved application.        has announced its first steps to introduce
and Drug Administration Amendments Act             This requirement extends to vitamins, herbs/     nutrition information for consumers when
of 2007 (FDAAA), and the EU with proposed          botanicals and metabolite products. Likewise,    eating out. Sue Davies, Senior Policy Adviser
legislative amendments to Directive 2001/83/EC     reporting requirements for cosmetics appear      at Which? commented: “Consumers don’t
and Regulation (EC) 726/2004. In the US, the       to be increasing in scope and complexity.        need to be told what to eat, but they should
FDAAA establishes that a Risk Evaluation and       Guidance drafted by the European Cosmetics       be provided with enough information to make
Mitigation Strategy (REMS) may be required to      Association (COLIPA) sets forth procedures       up their own minds. Supermarket product
ensure that the benefits will outweigh the risks   for adverse event capture, trend analysis for    labelling has helped, but as soon as you eat
of a drug. In addition, the emergence of “new      safety, and rep
To top