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What’s becoming increasingly evident is that drug development’s greatest adversary may not be bad science or the lack of funding. Instead, it may be the FDA who has the power to refuse the approval of a drug on numerous grounds such the all too common “insufficient evidence of efficacy” pronouncement. What you will find that very few novel drugs have been approved in recent years, only variations of previously approved drugs.The FDA can’t be blamed for all of the woes of the dismal drug discovery landscape. Much of it is a result of interplay between large and small biotech and pharmaceutical companies. However, the FDA is the referee in the drug discovery arena and is becoming increasingly more stringent in its approval policies. Many drug developers believe that the FDA is becoming too strict and believe that even blockbuster drugs of the past would not pass today’s hurdles. The FDA’s position is that the drug’s efficacy is the key to its success in the process and that the bulk of the drugs in the trial phases fail to deliver on the promised efficacy.Another reason why many new drugs are failing is because of the lack of understanding of its real market potential. Larger companies believe they have the resources needed to fully measure market potential against development activities. Couple this with the fact that larger companies usually have the financial resources needed to survive the lengthy approval processes. Smaller companies, however, usually prove themselves a formidable competitor because of the innovative research they develop. Smaller companies are more nimble and usually faster at coming up with novel approaches to drug discovery and development.The common practice of larger companies acquiring the smaller companies is both positive and negative for the overall development of new drugs. It’s positive in that the smaller companies are able to utilize the cash infusions to put their research into overdrive. However, what typically happens is that more promises are made to investors and analysts than can be delivered and the drugs fail. Because so many drugs are failing, larger companies are becoming more reluctant to buy novel ideas leaving potential blockbuster drugs shelved until they can be proven to be effective. All in all, the consumer loses. There has to be changes made across the board in the drug development industry for the sake of all current and future people across the globe who need those medicines to live their lives. The question remain, “What will be done?” | 
