Monday, February 20, 2012

Significant Events in the History of Pharmaceutical Testing

In the 10th century, the great Persian medical thinker Ibn Sina proposed what might be called, in today's parlance, pharmaceutical quality assurance guidelines: medicines must be tested on animals before on humans, medicines used in experimental trials must be unadulterated and pure, etc. But the field of pharmaceutical testing didn't really take off until the 20th century, when the industrialized countries saw the need to regulate food and drug quality assurance and quality control.
1906 - The United States Congress passed the Pure Food and Drug Act. This law established labeling requirements for drugs. One small step for man, one giant leap for pharmaceutical quality assurance! But there was still a long way to go.
1908 - Canadian Parliament passed the Proprietary and Patent Medicine Act, which prohibited the use of cocaine in medicines and required drug companies to indicate on the label if heroin, morphine or opium was an ingredient. A small but significant nod to quality assurance and quality control
1937 - The U.S. Congress passes the Food, Drug and Cosmetic Act requiring drugs to submit to pre-market pharmaceutical testing. This milestone in quality assurance and quality control came about as the result of a tragedy known as the Elixir Sulfanilamide Incident, where a new formulation of a drug used to treat strep infections was prescribed to patients without being tested, resulting in the deaths of more than 105 people in fifteen states. For the first time, The Food and Drug Administration concerned itself with quality assurance and quality control for new drugs.
1948 - The Nuremberg Code laid the groundwork for ethical pharmaceutical testing on human participants. The Code specified that human volunteers must be informed and protected from harm - a clear indictment of the practice of conducting experiments on prisoners of war.
1950s and '60s - Various countries, including the United States, Germany and Britain, reacted to the thalidomide baby tragedy by enacting new rules governing the reporting of adverse drug effects and clinical trials. In Canada, the tragedy led to a long overdue requirement for drug manufacturers to prove efficacy before proceeding to market.
'80s - The United States government developed an incentive program for pharmaceutical companies to pursue pharmaceutical testing and development in areas with fewer patients, i.e., to cater to less lucrative but needy markets.
In the same decade, perhaps in response to the HIV crisis, the pharmaceutical quality assurance process was fast tracked for certain drugs intended to treat conditions for which no other drug alternative existed.
1996 - New international standards for drug quality assurance and quality control were spelled out at an International Conference on Harmonization held in Brussels.
As for the future of pharmaceutical quality assurance, no one can say with any certainty what it holds.

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