Braille in Pharma: Differing Views in
the U.S. and Europe
Unlike all of the European Union countries where braille is
mandatory on pharmaceutical packaging, the U.S. still considers
it to be an optional guideline.
By Mike Botta, Contributing Editor
The United States has been at the forefront when it comes to most rules and regulations designed to help the handicapped. The Americans with Disabilities Act
(ADA) prohibits employment discrimination, and
governs a host of regulations aimed at providing
public accommodations, commercial facilities,
public transportation, and telecommunications
access for the disabled.
Federal laws protect the rights of disabled
voters, require access and accommodation for
passenger air travel, provide free individualized
public education for eligible disabled students, and
mandate that buildings and facilities designed,
constructed, or altered with federal funds, or leased
by a federal agency, comply with federal standards
for physical accessibility.
In essence, the U.S. has taken more steps than
most other nations of the world when it comes
to protecting disabled individuals, removing
barriers to accommodations, and ensuring a safe
environment for all.
EU Sparks Brief U.S. Frenzy
So, it may seem a bit odd that, unlike every nation
in the European Union, the U.S. still does not
require braille labeling on pharmaceutical product
packaging to aid the visually impaired.
When the EU stepped forward last decade to
order mandatory braille packaging on a host of
products, including drugs, there was a flurry of
activity throughout the pharma supply chain in the
U.S. as manufacturers, packagers, distributors, and
dispensaries began putting plans in place to bring
equipment capabilities onboard to handle braille,
expecting the U.S. to follow the European model.
But, the FDA did not issue mandatory
requirements, and a committee of the United States
Access Board issued guidelines instead, encouraging
but not requiring the addition of braille, a move
that industry sources welcomed since a government
mandate likely would have presented regulatory
challenges, but associations representing the blind
saw as a missed safety opportunity and potential
health risk for those affected.
An FDA spokesman, responding to an information
request from Pharmaceutical Processing, said that
the agency “would be open to reviewing braille
labeling on a drug product if a sponsor were to
submit for review,” pointing to the drug Hetlioz that
was “previously approved by the FDA with braille
labeling for brand name and strength.”
Industry and Trade Groups Step In
Despite the regulatory inaction by the FDA,
groups like the American Council of the Blind
(ACB) and the International Association of
Diecutting and Diemaking (IADD) stepped in and
took action to help industry include braille on
packaging and set standards that are consistent
across the U.S. and Canada.