(FDA) is the primary regulatory agency and
the Food Drug and Cosmetic Act (FDCA) is the
principal statute governing pharmaceutical pro-
ducts. The FDCA requires FDA approval of pre-
scription medicines as ‘safeandeffective’ before
they may be sold in the United States (emphasis
added). Regulations relating to pharmaceu-
tical products address the safety and efficacy of
pharmaceuticals and range from initial testing of a
drug to post-marketing surveillance. The law
regarding the conflict or balance between state
and federal laws – called ‘pre-emption’ – is con-
voluted and is the source of extensive legal debate
(see Chapter 52).
In the United States, as elsewhere, labeling is a
crucial issue in litigation. The FDA’s regulation on
labeling covers all written materials attached to or
accompanying the product or container, as well as
journal, television and radio advertising. The label-
ing used to inform physicians about the drug’s uses
and risks is a crucial element for the FDA’s deter-
mination of drug approval. The FDA regulates all
such labeling, including ‘all written, printed, or
graphic matter’ used in advertising the drug.
After FDA approval, a manufacturer may sell and
advertise the drug in accordance with the approved
uses on the drug label. ‘Off-label’ use is any use for
the drug that is not approved by the FDA.
As in other countries, the US federal regulation
of a drug does not end with the approval of the
drug and the company being granted a license for
it. The FDA requires drug manufacturers to
engage in post-market surveillance of the
approved drugs and can include revisions to the
labeling. A manufacturer must report to the FDA
and investigate any adverse events (AERs) in
accordance with FDA regulations. Further, FDA
regulations require a manufacturer to issue sub-
sequent warnings whenever there is ‘reasonable
evidence of an association of a serious hazard with
a drug; a causal relationship need not have been
proved.’ Pharmaceutical litigation in the United
States and elsewhere often centers on the manner
in which clinical trial data and AERs are pro-
cessed and reported and how such information is
incorporated into labeling changes. The pharma-
ceutical physician will often be central to this
process.
46.6 Legal procedures
Although most legal procedures are not directly
relevant to the work of the pharmaceutical physi-
cian, there are some procedural considerations
worth acknowledging. When pharmaceutical liti-
gation ensues against a pharmaceutical manufac-
turer, the manufacturer has a legal obligation to
preserve documents, including electronic corre-
spondence, that is related to the litigation. All
employees should heed such notices to preserve
documents and email correspondence. Failure to
do so may result in the company being sanctioned
by the court. It is worth bearing in mind that
memoranda, email and other types of internal
documents can become evidence in a lawsuit.46.7 Data protection
An important area which will impact on a pharma-
ceutical company, however, is the law as to data
protection. Governed in the United Kingdom by
the Data Protection Act of 1998 (enacted to comply
with EC Directive 95/46/EEC), this wide-ranging
piece of legislation was designed to allay privacy
concerns as technology developed allowing
widespread availability of information relating to
individuals. In the context of a pharmaceutical
physician or company, the main concern will be
data collection in clinical trials. The Act is based on
eight ‘principles’ by which all ‘personal’data must
be processed. Thus, the processing of personal data
is not prohibited, provided these principles are
adhered to and the Information Commissioner is
notified. Where data is considered ‘sensitive’, how-
ever, extra safeguards are added. The Act also
establishes certain rights of the data subject. On a
practical level, the Clinical Trials Directive has
introduced ‘EudraCT’, a European database for
interventional clinical trials with the aim that infor-
mation on clinical trials should be shared between
all member states. However, both this and the
Health Service (Control of Patient Information)
Regulations 2002 which apply to confidential
patient information expressly provide that they
should not be interpreted in a manner inconsistent600 CH46 PHARMACEUTICAL MEDICINE AND THE LAW