What challenges are faced by the US pharmaceutical industry?
Many prescription Rx drugs are going off patent in the near future and the pharma industry will lose billions of dollars to generic competition. Also, several of the large pharma companies do not have many new drugs in the pipeline to replace them. It is very difficult to develop new first-in-class therapies (12-16 years R&D timeline and about 1.3 billion for R&D spending). The number of new drug approvals at FDA has also been decreasing in the last 5 years. Are there unique challenges related to R&D costs & regulation specific to the US? R&D costs are higher here than in third world countries because labor and material costs are higher. We have cGMP requirements that drug manufacturers must adhere to. These regulations are often stricter than elsewhere in the world to ensure that we have a safe and efficacious drug supply. However, we also import food and pharma products made in China and we have all heard and read about the recent problems with products contaminated with melamine and
