Pharmaceuticals - Fundamentals of Industrial Chemistry: Pharmaceuticals, Polymers, and Business - page 166

The Generic Drug Enforcement Act of 1992 was the result of a scandal
involving allegations and proof that various generic drug manufacturers had
provided illegal gratuities to FDA reviewers and falsified data. Among other
provisions, the statute provided for disbarment of individuals and compa-
nies from submitting or assisting in any Abbreviated New Drug Applications
(ANDA) [18].
ANDA is the request to obtain approval to market a drug that has come
off patent, a generic drug. Information demonstrating that the generic ver-
sion is bioequivalent to the brand-name drug and does not infringe patents is
required. The generic drug must dissolve in about the same time and enter
the blood-stream at about the same rate as the brand-name version. The first
company to file an ANDA is given 180 days of exclusivity for the generic
version. The FDA maintains a list of approved drug products in a book enti-
tled “Approved Drug Products with Therapeutic Equivalence Evaluations.”
Because of the color of the topic, it is commonly referred to as the “Orange
Book.” The FDA maintains an electronic version of the Orange Book on their
website [19]. It is searchable by active ingredient, by proprietary name, and
by applicant holder.
As the need arises, Congress continues to pass laws to regulate the indus-
try. The laws are compiled in the Code of Federal Regulations (CFR). The
CFR is the codification of the rules published in the Federal Register by the
departments and agencies of the Federal Government. It is divided into 50
titles that represent broad areas subject to Federal regulation. Title 21 gov-
erns pharmaceuticals as well as many other areas such as food, cosmetics,
medical devices, and tobacco products. Title 21 is lengthy; it has nine vol-
umes, three chapters, and more than 1400 parts. Each part deals with a topic.
For example, in Chapter One, Part 201 covers labeling. Within Part 201, there
are over 60 sections. Some numbers are saved for future use, but they run up to
Section 326. Each section is on a specific topic and can have subsections. For
example, Subsection 301 of Section 201 is a notice to manufacturers, packers,
and distributors of estrogenic hormone preparations. The 21CFR regulations
can be searched online at government websites [20, 21].
The rules are administered by the Food and Drug Administration (FDA)
which is an agency within the Department of Health and Human Services
(HHS). HHS is a cabinet position within the government. There are more
than 50,000 employees and the 2014 budget is $975 billion. The FDA has
about 12,000 employees to protect the public health by assuring the safety,
effectiveness, and security of human and veterinary drugs, vaccines and other
biological products, medical devices, our nation's food supply, cosmetics,
dietary supplements, and products that give off radiation. Even with such large
resources, each year the FDA inspects only about 40% of domestic facilities
and 11% of international facilities that supply to the U.S. [22].