Pharmacology as we know it today
Was shaped by a lot of people along the way
Around the fifteen hundreds this guy named Paracelsus
Was a Swiss physician and alchemist
He spoke with knowledge not yet widespread,
“The dose makes the poison," he famously said
This laid the groundwork for modern toxicology
And he shifted things from plants toward chemistry
In 1906 the Pure Food and Drug Act was passed
It required ingredients to be accurately labeled at last
Misbranded foods and drugs could no longer be sold
Between states in the U.S. that’s how this story unfolds
In 1912 Congress added the Shirley Amendment
An early attempt to regulate drug labels’ content
Fraudulent claims about cures were made illegal
But it was still hard to prove the fraudulent intent of people
Pharmacology as we know it today
Was shaped by a lot of policies along the way
The Federal Food, Drug, and Cosmetic Act was passed in 1938
Leading to the drug approval process we still use today
Manufacturers are now required to prove drug safety
Before they market products that could cause a tragedy
This was a response to what happened with sulfanilamide
An antibiotic that killed over a hundred far and wide
A liquid version was released with children in mind
But the medication and a toxic chemical were combined
A couple decades later there was another tragedy
Thalidomide affected over ten thousand babies
When pregnant women were nauseous they took the medication
But it caused severe birth defects and major deformations
This triggered the Kefauver-Harris Amendment of 1962
And Good Manufacturing Practices were established too
Proving drugs were safe and effective became the priority
And the FDA was given a lot more authority
Pharmacology as we know it today
Was shaped by a lot of policies along the way
In 1970 a new system for controlled substances was created
Classified into five schedules so they could be better regulated
Its name is kind of a mouthful, now that’s a fact
The Comprehensive Drug Abuse Prevention and Control Act
By 1997, some more updates were needed
And the call for reform was finally heeded
When the FDA Modernization Act passed
It created a fast-track approval process at last
The goal was to bring beneficial drugs to market more quickly
Of course without compromising patient safety
Companies could also share off-label use information
Which changed drug advertising across the nation
Pharmacology as we know it today
Was shaped by a lot of policies along the way
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