reader is referred. Consistency between countries
is likely to increase now that drug licensing has
been centralized at the European Medicines
Evaluation Agency (EMEA). Many of the head-
ings within European labeling correspond to
those shown for Japan (Table 38.1 above) and
the United States.
American or Japanese physicians are fre-
quently surprised at European drug labels. The
brevity and the relative scarcity of quantitative
data reflect a very different philosophy. Such
labels arise from a regulatorymilieuwhich itself
has a different philosophy, expecting product
manufacturers to assume responsibilities that
would be accepted by the regulatory authorities
in the United States and Japan. There is no
European equivalent of the worldwide enforce-
ment arm of the FDA.
There can be no doubt that the principles that
underlie European labeling are the same as those
enumerated in other jurisdictions. Consistency of
promotional materials with the approved package
insert, the absence of misleading information in
package inserts, fair balance, absence of relevant
omissions and defensibility of all statements from
the clinical trials database are also characteristic of
good European labeling.
However, there is a widely expressed sentiment
in Europe that the long and technical labels
promulgated by FDA are unlikely to be read by
the ordinary prescriber. Thus, European labeling
aims for concise and well-balanced summary
information. For this reason, European labels are
usually more difficult to write than, say, American
ones, and are much more likely to be debated
among the physicians in a company’s medical
affairs department, and between the company and
the regulatory authority on subjective, interpreta-
tive grounds.
These fundamental differences between
European and American drug labels also lead to
unexpected, tangential difficulties, especially for
international corporations. The corporate lawyers
in the United States live in a more litigious
environment than their European or Japanese
colleagues. Plaintiffs’ litigation often makes
the claim that a patient has experienced an adverse
event that had not been disclosed in the package
insert. Companies are also sued in America for
adverse events that occur in Europe, and plaintiff’s
counsel will often wish to exploit the differences
that exist in drug labels between different jurisdic-
tions. Thus, the company lawyers in the United
States usually would usually like two things:
(a) any and all adverse event types to appear in
labeling, so that the company cannot be accused of
failing to disclose any relevant information; and
(b) consistency of such information in all drug
labels around the world so that a picture cannot
be painted suggesting to a jury that the company
was willing to warn Americans but not Europeans
of a particular adverse event type. Given the typical
inability to assign drug attributability to low-
frequency adverse events, and the philosophy of
European labeling, foreign subsidiaries often
object to the inclusion of (probably irrelevant)
minutiae in their labeling.38.5 Final words
The real key to understanding drug labeling is to
work with it, for real. Almost all entry-level medical
affairs positions can provide this if the post-holder
expresses appropriate interest. Similarly, almost all
successful drug development (i.e. phase I–III)
positions are guided by draft labeling. When writing
labeling, the first thing to do is to seek out a recent
model, for a drug that is already approved (indeed,
such models can also serve as guides to clinical
development plans at the very start of drug devel-
opment). When making judgments about how to
amend labeling and what may or may not be an
acceptablepre ́ciswhen converting a US label to a
European label, remember to seek the advice of
those with experience, both within the medical,
regulatory and legal departments.38.5 FINAL WORDS 533