Question

If a medication or device has been approved by the Food and Drug Administration (FDA) and deemed safe, but has later been found to be dangerous or even life-threatening in post-market analysis, should individuals be allowed to sue the manufacturer or to join a class-action suit against the manufacturer? Please give an example of a drug or device that was approved, but was later found to be injurious. What are the ramifications in terms of new drug development, technology development, or cost of new devices or treatments? How has the IUD (Intra-Uterine Device) been marketed, withdrawn, and marketed again? What caused the IUD to be embraced, rejected, and embraced again as a method of birth control

Answer 1

Once a drug is released, larger number and more diverse group of people will take the drug, and often for much longer periods of time. As a result ,new, rare, but significant ADR may be detected in the post marketing period once a larger group of people is exposed to the drug .In addition risk of ADR may be determined to be higher than previously assumed as the drug is used in a more diverse patient population.

Alatrofloxacin - withdrawn in the year 2006 world wide due to its adverse effects like serious liver injury leading to liver transplant or death.

Across the drug industry there are several mandated process that must be undergone before the final sale of a drug can begin on the market. One of the most important phase for overall drug is it's FDA approval. Differerent phases in development are

Discovery and development

Preclinical research

Clinical research

FDA review

FDA post Marketing safe monitoring

The market is driven by the increasing initiative by the government and non profitable organization to promote the use of IUD. Also long term efficacy and increased acceptance are anticipated to further boost the growth of the IUD in market. The increasing initiative by government and non profit organization to promote use of IUD is one of the major reason behind IUD market growth.