Drug Makers: Law for Generic Drug Makers Would Raise Cost

Published Date : Feb 18, 2014

The companies that make generic drugs and that most of the Americans buy are striving to fight against a proposed federal regulation. For just one time, this regulation requires to warn patients of every health risk each drug poses. 

This proposed rule change by the Food and Drug Administration would raise health awareness, care and costs for patients and doctors, said Ralph G. Neas, president of the Generic Pharmaceutical Association, an industry trade group. 

Supreme Court rulings drew a very rational and a sharp distinction between lower-cost generics and the brand-name drugs which by all means are the same products but just marketed under chemical names. 

In 2009, the high court confirmed that the drug makers could be sued if they did not succeed in warning the patients that brand-name drug also caused potential health risk. But the Supreme Court majority ruffled when the generic drug confrontation caused a terrible side effect.  

Many victims have been affected due to the drugs. For instance, a New Hampshire woman was badly burned and disfigured and nearly blinded after she had a reaction to the prescription painkiller, and similarly a Vermont violinist’s lower arm was surgically removed after she was injected with an anti-nausea drug made by Wyeth. Sometimes, the drug caused gangrene when injected into an artery.

In November, as proposed by the FDA, the drug makers were allowed to change their warning labels when any medical reports caused new problems. The FDA added that all generic drug makers would be individually responsible to ensure that the product labeling is correct and up-to-date. 

All the proposals met violent oppositions from the generic drug industry, and the members refused to support any such rule that undermined public health just to execute litigation against generic drug companies.