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Transcript
SUPPLEMENTARY MATERIALS AND METHODS
We used the Drugs@FDA database (downloaded on March 19, 2014), which lists all
regulatory actions by the US Food and Drug Administration (FDA), to determine the number
of new drug approvals by year. A new drug approval was defined as the first approval of a
new drug application (NDA) for a new molecular entity or for a drug already marketed
without an approved NDA. We also considered as a new drug approval the first approval of a
biologics license application (BLA). We excluded drugs distributed “over the counter” and
duplicate records of the same drugs by using the application number as a unique identifier.
We used the Anatomical Therapeutic Chemical (ATC) classification12 to identify the
therapeutic area (oncology or non-oncology) corresponding to the drug indications. A drug
can have multiple ATC codes (if multiple indication by example). We defined a drug as being
for oncology if at least one corresponding level 2 ATC code was "L01" (i.e., antineoplastic
agents) or a level 4 code was “V10X,” which corresponded to three different Iodine 131I
compounds.
We mapped ATC classifications with our list of new drugs in a three-step strategy:
1. We merged our database with the ATC classification by using international
nonproprietary names (we used the variable “activeingred” of the “Product”
table, after trimming spaces and lowering cases) and could match 557 of 1,206
unique drugs (46%).
2. For 649 unique drugs without a matching ATC code, we used only the first
word of international nonproprietary names because, for example, in the
Drugs@FDA database, ZIAGEN is identified as “abacavir, sulfate” but as
“abacavir” in the ATC file. However, when the first word was “sodium”, we
did not map it to ATC codes because this could lead to mapping different
drugs to the same ATC code. In this second step, we matched 489 drugs
(75%).
3. For the 160 remaining unique drugs, an investigator (AV) manually checked
the drugs to identify oncology-related drugs and drugs not suitable for
inclusion (see below). Some of the drugs did not have an ATC code, and others
were simply not matched.
We also excluded vaccines, diagnostic and contrasting agents by using the following
ATC codes or manually for those not having an ATC code.
-
B05A: blood and related products
-
J07: vaccines
-
V04: diagnosis agents
-
V07A: all other non-therapeutic products
-
V08: contrast media
-
V09: diagnosis radiopharmaceuticals
-
First letter = Q: veterinary products