FDA act – LABEL
FDC amendments – SAFETY
Harris-Kefauver Bill – EFFICACY
Hatch-Waxman Bill – GENERIC DRUGS &PRICE
FOOD, DRUG AND COSMETIC ACT (LABELLING ):
The main purpose is to ban the foreign
products, adulterated or misleading food and drug products.
The active ingredients must be stated on
the labels in which the purity levels do not fall below during the drug
The flaws in the past years before
regulating this labelling procedure was there was no standards maintained in the
drug advertising. The implementation of this regulations resulted to a proper
labeling and identifies the official standard for the drugs.
– LABEL EVOLUTION 1:
· The indications
of the drug were mentioned.
dosage level was written.
possible interactions were given.
· And other
information’s of the drug in the container.
The FDC amendments listed out the
regulations which has to be improvised in this year on these criteria, such as
The lack of inspections
for the safety of the drug.
The control the falsified
claim of the drug by the manufactures and also the patients.
This regulation of safety
took after a major tragic incident of SULFANILAMIDE
The proof of safety for each
drug was introduced in this year.
Only authorized inspections.
– LABEL EVOLUTION 2:
The complete list of
ingredients should be present in the label of the drug container.
The directions for safe
use has mentioned.
The worst disaster for
the pharma industry took place in this year “Thalidomide Disaster”.
The drug was called off
for the revisions.
It was first banned in
the united states.
Thousands of them were
The effectiveness of the
drug percentage to be mentioned and maintained.
The authority of the
regulating the advertising of prescription drugs were given to the FDA after
The good manufacturing
practices (GMP) was established after this.
The birth of developing a
drug by replicating the same API and ingredients used to develop the actual
It removed the de facto
patent extension by approving that, a research can be conducted during the
patent life of a product.
It defined that there is
a no need to prove the safety and efficacy for the drugs. Judging the bioequivalence.
There are few other legislative acts which
happened after 1962 of THALIDOMIDE DISASTER, they are:
= Bayh-Dole Act
= Orphan Drug Act
There a few more approvals and regulations
were introduced after the 1990’s
The FDA allowed to
collect the fees from the industry.
They reduced the review time
which was conducted by the FDA.
– The change label to include the cardiac arrhythmia,
syncope and hypotension under the adverse events.
– The warnings under the drug interactions were included by more labeling the
& 1996 – The manufacturer required to send “dear
doctor” letter to all the prescribers.
– The label added a warning called “BLACK
– The drug-drug interactions were survey commissioned.
– The seldane was totally withdrawn from the