Drug Industry Innovations and the FDA
There was an interesting story on page B3 of the Wall Street Journal [of Medicine] today. It explained GlaxoSmithKline’s strategy to extend its brand drug patent protection through the use of “RL” and “CR” extended release versions. Drug modifications like this have enabled GSK to keep sales rising despite difficulty bringing brand-new drugs to market.
One pharmaceutical analyst was quoted as saying, “The whole industry is finding it difficult to get through the FDA with line extensions because the FDA is understaffed and focusing on things they think are more innovative and important.” We can only hope this is true.
An FDA spokesperson said, “The law does not allow the FDA to discriminate against any new drug application based on what else is already on the market.” Well, here is to hoping the FDA manages its resources well without running afoul of the law, and drug manufacturers respond with real innovations instead of line extensions.