Discussion: prescription drugs Thursday, April 28, 2016 6:56 PM
Drug importation act Food and drug act Food, drug and cosmetic act 1959- First signs of corruption when a drug's company's payments to a top FDA official were publically revealed 2009- Pfizer pays $2 billion in fines after misleading marketing of the inflammatory drug Bextra
NECC Compound centers: when they mass produce medicine, not newly developed
FDA Modernization Act 1997- barred the FDA from treating compounders as a drug manufacturer
Should congress recognize compounders as a new category of drug makers? Or should they be regulated exactly like pharmaceutical companies? Know why they should be regulated the same and differently
Clinical trials process Drug companies try to ensure the safety of their drug through a series of clinical trials ResuIts reported to FDA However, pharmaceutical companies help to fund the approval process prescription drug user fee act- all applicants seeking FDA approval help fund drug evaluations Accelerate review of results by paying for excess staff
Should pharmaceutical companies have this much control over the clinical trial process? Yes Vs No
Regulating pharmaceutical marketing
This was addressed in class Companies try and sway doctors to prescribe their drugs O "culture of corruption'
Should drug companies be able to sacrifice time over effective results in the clinica trials?
Example of the company that bumped up the price from $13 to 750.... Is there a way that the US can shift towards Japan's medical policy?
#1 lobbyist group was pharmaceuticals re: congress
Price of drugs
Balance between research
Controlling pharmaceutical industry
Consumer advertisi