Concern is rising following proposals that could enable thousands of imported counterfeit drugs to be given to patients in America.
US senators have been trying to use plans to repeal the so-called Obamacare health provisions to make amendments that could see the drugs market flooded by potentially dangerous drugs from abroad, according to critics.
The amendment proposed by senators Amy Klobuchar and John McCain would loosen controls on laws governing drug importation. Although the amendment failed, it has served to reveal how certain politicians fail to appreciate the dangers of opening the prescription market to possibly unregulated products.
According to those in the know, imported drugs cannot be relied upon to be either safe or reliable. Foreign drugs may not have passed the stringent checks and balances required to maintain their effectiveness and safety.
The World Health Organization says such substandard, spurious, falsely-labelled, falsified and counterfeit – otherwise known as SSFFC – medical products are difficult to detect. Often designed to appear the same as the genuine product, they may not cause an obvious adverse reaction if taken but could fail to properly treat the condition or disease for which they are intended.
Imported drugs may have been produced in unsterile conditions, are probably untested, and could cause serious harm or even death to those who take them. Fake drugs are known to have caused deaths in numerous countries, including the US.
The Food and Drug Administration (FDA) is the American federal agency responsible for testing all new drugs and medical devices. Under its jurisdiction, the US operates one of the most comprehensive regulatory and approval structures for medicine in the world, ensuring that all medicines work and, above all, are safe to use.
Anyone wishing to introduce a new device or medicine onto the market must go through a serious of rigorous tests and procedures before being approved for use.
If you want to know how long does it take to get a FDA 510k approved, services such as http://www.fdathirdpartyreview.com/ can provide you with more information.
Most medical experts believe that the FDA plays a vital role in helping to keep medicine safe in the US and that any relaxing of the laws regarding imported drugs would be detrimental to not only the health of the nation but also to the US pharmaceutical industry.