AIDS Update, Volume 8, Number 2, February 1993 Page: 2
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Contemporary Issues in Healthcare
Part II: The Food and Drug Administration
By Stan Pennock, Nelson-Tebedo Clinic Advisory CommitteePeople with serious and life-threaten-
ing illnesses depend on drugs for treat-
ments and cures. Individuals with HIV
infection are among those who wait for
new drugs to be approved by the Food
and Drug Administration (FDA) in the
hopes that their suffering will be less-
ened. This report, divided into two
parts, explains the function of the FDA.
This month provides a description of
the FDA and the laws that have served
to shape the FDA.
Scope of the FDA's
Authority
The FDA operates within the U. S. De-
partment of Health and Human Ser-
vices. The position of FDA Commis-
sioner is a political appointment. The
current head of the FDA is David
Kessler,a physician, who was appointed
by President Bush.
The FDA primarily serves to regulate
the pharmaceutical industry. Pharma-
ceutical manufacturers develop and test
new drugs for safety and effectiveness,
but it is the responsibility of the FDA to
evaluate the test results and approve
the new drug for marketing. A drug
manufacturer submits a typical New
Drug Application (NDA) to the FDA
which contains between 5,000 and
100,000 pages of study results and other
data. The NDA is reviewed by hun-
dreds of FDA specialists who carry a
collective caseload of some 15,000 ap-
plications (for new drugs, generic drugs,
investigational new drugs, and supple-
ments to these applications). If the
FDA approves the new drug for
marketing, the drug will be ap-
proved only for the use that was
established during the testing pro-
cess.
The function of the FDA is to ensure
that all drugs, medical devices, and
biological products (vaccines) on the
market in the United States are both
safe and effective. Even condoms
must be proven to be safe and effec-
tive. The new female condom was
determined to fail 12% of the time
and might not be approved by the
FDA. The FDA's concern with drugs
is only with pharmaceuticals. A
pharmaceutical is defined simply as
"any substance used as a medicine
in the treatment of disease".
The FDA is not concerned with illicit
drugs such as marijuana and crack co-
caine. Illicit drugs are under jurisdic-
tion of the Drug Enforcement Admin-
istration (DEA), which operates within
the U.S. Department of Justice.The FDA is also concerned with cos-
metics, foods, and nutritional products,
but only to the extent of their safety.
Yet, if such a. manufacturer makes a
claim that the product "reverses the
aging process" or "melts fat away",
then the claim must be proven. New
drug products are emerging that are
termed "cosmeceuticals" and
"nutraceuticals". These are cosmetic
and nutritional products that are mar-
keted with specific pharmaceutical
claims that have been proven.
The FDA has jurisdiction over the labels
and labeling of food, drug, cosmetic,
and nutritional products, but the Fed-
eral Trade Commission (FTC) has au-
thority over false advertising. In a simi-
lar manner, the FDA advocates stricter
labeling requirements for the nutritional
composition of packaged foods (want-
ing to list the number and percent of
calories that are separately provided by
carbohydrates, fats, and proteins), than
does the U.S. Department of Agricul-
ture concerning meat, fish, and poultry
products (influenced by the meat indus-
try, in that this measure would indicate
the excessive fat content in some prod-
ucts), which are under its jurisdiction.
Laws Relating to the FDA
From the beginning of civilization,
people have been concerned about the
quality and safety of foods and medi-
cines. In the United States, the regula-
tion of food began in early colonial
times. The regulation of drugs began in
the year 1848 with the inspection of
imported drugs. A history of the more
recent federal legislation that led to
today's FDA follows. Included are dis-
cussions of the events that served to
shape the various laws and amend-
ments, in the likelihood that some read-
ers have special interests or curiosities.
The Food, Drug, and Cosmetic Act
(1938) established the FDA. Specifi-
cally, the act requires that drugs be
proven safe prior to marketing. The
precipitating event was the "sulfa-
nilamide elixir tragedy" when over
100 people died from a new product
that had not been tested for safety.
The Durham-Humphrey Amendment
(1951) to the Food, Drug, and Cosmetic
Act divided drugs into two categories,
prescription and non-prescription. The
amendment requires that prescription
drugs in the manufacturers' packages
contain the legend "Caution: Federal
law prohibits dispensing without a
prescription." These "legend drugs"
are restricted to sale only upon aprescription order and may not be re-
filled by a pharmacist without authori-
zation of the prescriber.
The Kefauver-Harris Amendment
(1962) to the Food, Drug, and Cosmetic
Act requires manufacturers to also es-
tablish the effectiveness of all new drug
products prior to marketing. In addi-
tion, drugs that were approved for
marketing by the FDA between 1938
and 1962 were required to undergo a
review for effectiveness. More than
3,000 drug products were involved
(many drugs contained multiple ingre-
dients). The ingredients of each prod-
uct were classified as effective, prob-
ably effective, possibly effective, or not
effective. The FDA removed a great
number of prescription drugs from the
marketatthat time. Note thatthislawdid
not apply to drugs that were marketed
before 1938. Presumably these drugs had
already proven their safety and effective-
ness. Digoxin and phenobarbital are two
of these drugs that remain in use today.
, The Orphan Drug Act(1983) allows the
manufacturers of certain drugs to have
seven years of exclusive marketing
rights and toclaim 63 percent of the cost
of clinical trials asa tax credit. These are
drugs that are used to treat any one of
approximately 2,000 rare diseases that
affect patient populations of less than
200,000. It is obvious that the total
market is smaller for rare diseases, such
as toxoplasmosis, than it is for common
diseases, such as hypertension. That is,
the manufacturer's earnings potential
is smaller and needs special incentives
to develop these lesser used drugs. In
addition, efforts from the FDA's Office
of Orphan Drug Development have
resulted in high priority "fast track"
approvals for orphan drugs. An ex-
ample of an orphan drug is Marinol, the
synthetic version of marijuana that the
FDA recently approved to treat appe-
tite and weight loss in patients with
HIV disease.
The Drug Price Competition and
Patent Term Restoration Act (1984)
was the result of a compromise be-
tween the Pharmaceutical Manu-
facturers Association (PMA) and
the National Association of Phar-
maceutical Manufacturers
(NAPM). The former represents the
interests of the brand-name (re-
search based) drug manufacturers
while the latter represents the inter-
ests of the generic drug manufac-
turers. At issue was the drug ap-
proval process of generic drugs. The
Kefauver-Harris Amendment speci-
fied that all new drugs approved formarketing after the year 1962 shall
be proven effective. Nothing in the
law addressed the approval process of
generic equivalents for those drugs.
The NAPM maintained the view that
all formal testing of these drugs has
already been performed by the
brand-name (research based) phar-
maceutical manufacturers and that
requiring the process to be repeated
would only serve to both delay the
introductions of needed generic
drugs and to raise their prices.
The PMA countered that generic manu-
facturers should be required to submit
a complete NDA. Their rationale was
that many years of a new drug's patent
protection are consumed by the formal
development process and that a brand-
name (research based) manufacturer
should be entitled toa few extra years of
patent protection while the generic com-
pany develops its competing product.
(A firm applies for a patent on its new
drug at the time of the initial synthesis.
The term of a patent is 17 years.)
The compromise between the two in-
terest groups was that generic manu-
facturers would be allowed to, instead,
submit an Abbreviated New Drug Ap-
plication (ANDA) to the FDA. The
ANDA is to detail their manufacturing
processesand studies of bioavailability,
thus assuring the same therapeutic ef-
fect as the original drug. In return, the
brand-name (research based) manufac-
turers would receive an extension of up
to five years of the patent on their drugs
that had been consumed during the
development process.
Since 1983, the FDA has approved a
flood of generic equivalents for
drugs whose patents have expired
since 1962. Such approvals totaled
80 in 1990, 188 in 1991, and will total
an even greater number in 1992.
The newest law that affects the pharma-
ceutical industry originated in the Pre-
scription Drug User-Fee Act (1992).
The intent of this act is to allow the FDA
tocutin half the time ittakes to approve
a new drug once the manufacturer has
submitted a NDA. Drug manufactur-
ers will pay the FDA $330 millionin fees
over the next five years, allowing the
agency to hire 600 additional employ-
ees to accelerate the review and ap-
proval process. In 1992, the FDA's
time spent to evaluate a NDA and
approve a new drug averaged 23
months. The FDA expects that the
new plan will decrease this time to
12 months or less.February 1993J
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AIDS Resource Center (Dallas, Tex.). AIDS Update, Volume 8, Number 2, February 1993, periodical, February 1993; Dallas, Texas. (https://texashistory.unt.edu/ark:/67531/metadc1584237/m1/4/?q=%22gay+urban+truth+squad%22: accessed July 16, 2024), University of North Texas Libraries, The Portal to Texas History, https://texashistory.unt.edu; crediting UNT Libraries Special Collections.