The sub-headline of Dr. Kenneth Beer’s article in the March
2013 issue of The Dermatologist reads: “There are numerous
ways to decrease the cost of toxins and fillers,
including importing materials from another country and using
less expensive materials, but the results achieved with such
products may be less than optimal.â€1 There is nothing incorrect
about this statement; but the possibly harmful repercussions to
both patients and practitioners may be significantly greater than
outlined in that article. Karen Rothschild, a Regulatory Counsel
with the Food and Drug Administration (FDA) in the Center for
Drug Evaluation and Research (CDER), has partnered with Dr.
Beer to elucidate the scope of the issues such practices raise.
FDA’s Office of Drug Security, Integrity, and Recalls
To help protect patients from the potential harm caused by impure,
counterfeit, or otherwise illegally sourced drugs, the FDA
has established an office within CDER’s Office of Compliance that
is dedicated to promoting the quality, integrity, and security of human
drugs for US patients. Due to the global sourcing of drugs
and easy availability of products distributed through dubious
supply chains, there was a need to establish such an office. The
increasingly complex global drug supply chain has increased the
risk of patient exposure to substandard drugs and has necessitated
that the FDA dedicate more resources to protecting patients
from counterfeit, diverted, or intentionally adulterated drugs.
Drugs purchased through the legitimate, regulated supply chain in
the US continue to be safe and effective. The US has one of the
most secure regulated supply chains in the world. However, when
there is an opportunity to increase profit, unscrupulous suppliers,
doctors, other practitioners, and corporations may seek to exploit it.
And patients may seek out less expensive “alternative†drugs, without
considering or understanding the risks that arise from obtaining
drugs from unregulated sources. The combination of a global recession,
increasing drug prices, and improving manufacturing and
printing technologies create sophisticated counterfeiting opportunities
that are cheaper and easier for criminals.
Over the past 2 years, FDA has sent informational letters to well
over a thousand doctors, to provide information about suppliers
working outside of the legitimate pharmaceutical supply chain.
Despite these warnings, some doctors have elected to continue
purchasing less expensive products through questionable suppliers.
Some of these doctors may know that they are buying
unregulated products, but many do not. Amongst the recipients
of letters have been many cosmetic doctors, medi spas,
and medical practices that were known to have purchased or
received drugs from unlicensed, foreign, and unsavory suppliers,
which FDA has confirmed have sold substandard or counterfeit
products. When a product is unapproved or comes
from a source outside of the regulated supply chain, no one
monitors the quality of manufacture, storage, or the purity of
the ingredients. Quite simply, no one is looking.
Possible Harm to Patients
Patients may be harmed by drugs that have not been approved
by FDA, as the products have not been determined to be safe or
effective, and the companies (or individuals) making the drugs
have not had their manufacturing practices or handling procedures
inspected by FDA. This means that there is no guarantee,
or even a reasonable expectation, that the drugs are of suitable
quality and there is no reason to believe that they been proven to
be safe and effective pursuant to FDA standards. Drugs imported
from foreign or unlicensed suppliers may be from unknown
sources, may have unknown ingredients, may be counterfeit, or
may not have been manufactured, transported, or stored under
proper conditions as required by US law, regulations, and standards.
Drugs that have not been reviewed for safety, efficacy,
and good manufacturing may be subpotent, superpotent, or
have no active ingredient whatsoever. These products may not
be even remotely close in composition to what the drug is being
advertised as by those trying to sell them. They could lead to
poor results, adverse reactions, or worse.
With respect to botulinum toxins in general, and Botox® in particular,
the potential for harm to patients is not new. In November
2004, four patients became paralyzed after being injected with potent,
unapproved botulinum toxin that a doctor used instead of
FDA-approved Botox® Cosmetic. By July 2008, 29 people had been
convicted of purposely using an unapproved, cheaper version instead
of FDA-approved Botox® Cosmetic. These people injected
about 1,000 unknowing patients. Unfortunately, despite publication
of their names in several local and national newspapers,
many of these practitioners remain in practice. Particularly with a
toxin, doctors have long known about the precision required for
optimal results and for patient safety. However, because patients
trust their medical provider to obtain safe and effective injections,
patients should be suspicious about any “deals†or discounts. Patients
should also be aware that when doctors start to compete
based solely on price, the pressure to dilute the products injected
may increase substantially. Dilution of Botox® is the most common
reason for patient complaints to doctors that the injections
“don’t last†or that “Botox just doesn’t workâ€.
How Patients are Scammed
Botulinum toxins are now undergoing a new phase of counterfeit
that is extremely dangerous. In contrast with the events of
2004 where the doctors knowingly used an unapproved product
instead of Botox® on unsuspecting patients, the new danger is
primarily driven by patients who demand ever less expensive
injections. They come to their doctor offices armed with internet
