preview

The Use Of Biologics And Medical Devices Should Be Strict

Decent Essays
The level of regulation governed by the FDA over drugs, biologics & medical devices is a widely debated topic. In my point of view, the level of regulation on drugs, biologics and medical devices should be strict. The current regulations governed by the FDA are very strict and should remain that way because the base of these regulations are underlined by various tragedies which we don’t want to be repeated. For instance, the thalidomide incident in which many children were born with Phocomelia (shortening or absence of limbs). Thalidomide, which started as an OTC drug in 1957 as a remedy for sleeplessness was later found to have off-label effects such as mitigation of morning sickness in pregnant women. Hence was then prescribed worldwide to pregnant women. However, in 1962 Frances Kelsey prevented the approval of this drug in the USA. This resulted in Harris-Kefauver Amendment in 1962 which tightened the investigation and approval of drugs requiring the manufacturers to prove their safety and efficacy. Many incidents could be avoided in the past if the regulations were firm and so there is an utter necessity of governing bodies for oversight of clinical trials, new drug development and manufacturing of drugs, biologics and medical devices. Many of these unfortunate events were mishaps, but there are many such incidents which are the result of greed and corruption leading to adulteration of drugs, cosmetics and food products. Until the 19th century the slaughter,
Get Access