The US Food and Drug Administration (FDA, www.fda.gov
) has launched a program to engage health professionals in helping to detect and report misleading prescription drug advertising.
The program is being administered by the Division of Drug Marketing, Advertising and Communication (DDMAC, link
) in the Center for Drug Evaluation & Research (CDER). Historically, DDMAC focused on approving marketing materials
submitted by drug companies for approval, response to consumer complaints and field activities at large public venues but
did not have a robust program to address the proliferation of targeted direct to consumer advertising. With issues and
the potential for abuse growing, DDMAC has embarked on a program to directly entreat the health professional community to
voluntarily serve as watchdogs for DDMAC and the FDA ("FDA: ‘Bad Ad Program’ to Help Health Care Providers Detect, Report Misleading Drug Ads"
). The hope is that by leveraging the knowledge and significant "eyeballs" of our nation's health professional
community that reporting of misleading, inaccurate or unsafe pharmaceutical advertising will increase and improve the FDA's
ability to regulate product marketing. While not clearly stated, it is implied that these new reporting avenues will
tie into other FDA post-market surveillance activities if a direct enforcement activity does not occur. It will be interesting
to see how the FDA's reform of its MedWatch
program to MedWatch Plus
and the continued development of an enterprise-wide adverse event reporting system (FAERS
) and the plan to contract services to monitor the internet to identify the potential illegal sale and marketing of FDA regulated products
. These activities are part of a significant push by the FDA to address consumer and product safety and as these activities
grow and strengthen we should see more robust protection of the public health and attendant improvements in safety and quality
of health outcomes.