On Pharma's Shoulders
The United States has the safest supply of drugs in the world—when they are acquired through standard distribution channels.
However, the public now encounters increasingly aggressive internet marketing that falls outside of the normal physician/pharmacy
supply chain and is a ready outlet for the distribution of counterfeit or illegal drugs. The actual size of the US internet
counterfeiting problem is uncertain. But according to a September 29, 2003 FDA News report, an estimated 80 to 90 percent
of these products do not meet US regulatory requirements, and more than 40 percent of the drugs coming into the US through
the internet, from countries such as Mexico, are fake. (For more information about counterfeit drugs, see "Resources".)
Both FDA and Congress are now relying on pharmaceutical companies to design their packaging and products in a manner that
deters counterfeiters. The responsibility of finding innovative methods of ensuring the security of the nation's drug supply
is being put squarely on the shoulders of pharmaceutical manufacturers.
On January 15, 2004, a congressional letter was sent to major pharmaceutical companies, requesting that they provide information
about the development of plans to prevent counterfeiting and diversion of their products. Congress also wanted to know what
actions and countermeasures were being taken relating to specific products being marketed by the illicit internet sites of
At the same time, FDA plans to publish a guide about notification procedures for changes made to products, packaging, or labeling
for the purpose of detecting and deterring counterfeit drugs. Regulatory hurdles to making these specific types of changes
are now being lowered.
With high-definition imaging technology, coded images can be designed into logos, acting as fingerprints that make tablets
difficult to duplicate.
No single anti-counterfeiting technology can provide adequate protection. Pharma's objective must be to design products and
packaging with features that are so hard to duplicate that counterfeiters will turn their sights elsewhere. Fortunately, there
are many proven on-tablet technologies available today that can make drugs difficult to fake but easy to identify. These technologies
- visual identification—unique colors, shapes, sizes and logos
- electronic identification—bar coding
- chemical identification—edible markers in the film coating
- sensory identification—flavors and aromas with a unique profile
Round, white, uncoated, debossed tablets are easy to copy and cheap to produce. A tablet press is all that's needed. On the
other hand, unique colors, sizes, shapes, and high-definition logos can aid in quick and accurate identification of tablets,
making counterfeiting extremely difficult. The more technologies that are used, the more difficult they are to counterfeit.
New pearlescent coating technology allows pharma manufacturers to visually distinguish their products from counterfeits and
other drug products. The uniquely colorful pigments created with this technology all meet current 21 CFR colorant regulations
and are custom-produced to exact specifications in a single-use, GMP facility, the only one of its kind in the US. Because
this technology is only available through controlled channels, the opportunity for counterfeiters to gain access to pearlescent
pigments anywhere else in the marketplace is effectively eliminated.