Principles and Practice of Pharmaceutical Medicine

unsound, to expect 35 years of change to be cor-
rected overnight, and at the same time, maintain a
productive regulatory agency. Congress allowed
for an implementation period. The second reason
flows from the first. The drug development process
is long and resource-intense. It is difficult to turn
midstream. Once the FDA starts changing, the
industry will have to respond with changes in the
development process. This takes even more time.
Simply stated, many of the changes have just not
had sufficient time to get into the process.

31.2 Economic considerations

FDA has jurisdiction over about 20–25% of the
gross national product (GNP) of the United States.
In 1996, the FDA-regulated industries comprised
about $1750 billion (i.e. $1.75 1012 ), thus dwarf-
ing the US Department of Defense budget by about
a sixfold difference. This is about 150% of the
entire GNP of the United Kingdom. These regu-
lated industries include all medical devices, all
drugs, many other OTC orin vitrodiagnostic mate-
rials and almost all food (meat is still the respon-
sibility of the Department of Agriculture under
Teddy Roosevelt’s 1906 Act). These activities are
all mandated by the FD&C Act and its various
amendments.
In addition, FDA engages in various cooperative
projects with organizations such as the National
Institutes of Health, the Centers for Disease Con-
trol, the Drug Enforcement Agency and the US
Public Health Service (many of whose officers
serve attachments to FDA). A certain amount of
independent research is supported in the FDA bud-
get, as well as international liaisons. FDA, too,
conducts lobbying and legislative functions.

31.3 Organizational aspects

FDA is part of the Department of Health and
Human Services, which is represented at Secretary
level within each President’s cabinet. The secretary
appoints a commissioner to head the FDA, and this
is usually a political appointment (i.e. not held by a
career civil servant). The commissioner appoints

assistants or deputies to head the following centers

or offices:

CDER

CBER (now with a far smaller remit than

previously)

Center for Food Safety and Applied Nutrition

Center for Devices and Radiological Health

Center for Veterinary Medicine

Office of Regulatory Affairs

Office of Orphan Product Development

National Center for Toxicological Research

The assistant and deputy commissioners might be

either political appointees or career civil servants.

Each of these subdivisions is typically further

subdivided. For example, CBER has offices of

Management, Compliance, Therapeutic Research

and Review, Vaccines Research and Review, Estab-

lishment Licensing and Product Surveillance,

Blood Products and Communications and Training.

Each are typically led by career civil servant Office

Directors, although, currently, the Office of Orphan

Product Development is headed by a Rear-Admiral

from the US Public Health Service.

CDER has a larger product development res-

ponsibility than CBER, and thus has five Thera-

peutic Review Divisions, each led by a career civil

servant Division Director. But the other divisions

are similar to the CBER model, with divisions for

Epidemiology and Statistics, Compliance, Phar-

maceutical Sciences (including a specialized office

of New Drug Chemistry), Biopharmaceutics and

Generic Drugs. It seems likely that an Office for

Toxicology will soon be established.

Most centers or offices have access to a network

of field-based inspectors. These inspectors operate

worldwide, and audit both animal and clinical

studies, as well as manufacturing processes and

premises. Such audits can be ‘for cause’, for

example a complaint from the public or an

31.3 ORGANIZATIONAL ASPECTS 401