pharma regulation 

REGULATIONS
OF FDA

 

1906:
FDA act – LABEL

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1938:
FDC amendments – SAFETY   

1962:
Harris-Kefauver Bill – EFFICACY

1984:
Hatch-Waxman Bill – GENERIC DRUGS &PRICE  

 

1906
(LABELLING DRUGS):

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
packaging.

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.

REGULATIONS
– LABEL EVOLUTION 1:

·      The indications
of the drug were mentioned.

·      The
dosage level was written.

·      The
possible interactions were given.

·      And other
information’s of the drug in the container.

 

1938
(DRUG SAFETY):

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
DISASTER.

·     
The proof of safety for each
drug was introduced in this year.

·     
Only authorized inspections.

REGULATION
– 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.

 

1962
(DRUG EFFICACY):

·     
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
harmed worldwide.

REGULATIONS
– EFFICACY

·     
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
this.

·     
The good manufacturing
practices (GMP) was established after this.

1984
(GENERIC DRUGS):

·     
The birth of developing a
drug by replicating the same API and ingredients used to develop the actual
drug.

·     
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:

1980
= Bayh-Dole Act

1983
= Orphan Drug Act

There a few more approvals and regulations
were introduced after the 1990’s

APPROVALS:

1.   
The FDA allowed to
collect the fees from the industry.

2.   
They reduced the review time
which was conducted by the FDA.

REGULATION
ACTIONS:

1.   
1987
– The change label to include the cardiac arrhythmia,
syncope and hypotension under the adverse events.

2.   
1989
– The warnings under the drug interactions were included by more labeling the
content.

3.   
1990
& 1996 – The manufacturer required to send “dear
doctor” letter to all the prescribers.

4.   
1992
– The label added a warning called “BLACK
BOX”.

5.   
1996
– The drug-drug interactions were survey commissioned.

6.   
1998
– The seldane was totally withdrawn from the
market.