Big Pharma in the United States has been frustrated for years, by how long the FDA new drug approval process takes before a new drug may be brought to market. Big Pharma complains that the process can sometimes take years due to unecessary prolonged testing for things like consumer safety. Well unbeknownst to many consumers, Big Pharma has successfully circumvented cumbersome FDA testing for many drugs with the 2012 passage of the FDA Safety and Innovation Act (FDASIA).
The FDASIA streamlimes approval for new drugs that are deemed to be "breakthrough therapy" or according to the FDA, are drugs that are used for serious and life threatening conditions. If the new drug may have a substantial improvement on at least one clinically significant end point over therapy, then the drug qualifies. When discussing the new streamlined approval process, Johnson & Johnson Head of Global Regulatory Affairs Dr. Jay Siegel stated, "Everything is on the table." Johnson & Johnson, which has been implicated in dozens of drug and consumer product recalls in recent years, is currently pressing the FDA to designate its new ibrutinib drug for cancer as a breakthrough therapy in order to rush it as quickly as possible to market.
While the purpose behind the FDASIA is commendable, potential problems arise in that such "breakthrough therapy" drugs require minimal testing at best. Further, these drugs may be approved in a matter of just a few months as oppose to years and once they are brought to market, the FDA has no specific requirement to continue any safety testing for the new drug. In addition, the way the requisite language of the FDASIA is worded, it arguably opens the flood gates to countless drugs that are beyond the Act's intended scope and purpose.
Fast tracking the approval of a life saving drug is something most all of us would desire, especially if you or a loved one may be saved by such a new drug. Unfortunately, it appears that Big Pharma has exploited this consumer desire by once again successfully manipulating the FDA to serve Big Pharma's own greedy purposes.
Long Island Lawyer
Paul A. Lauto, Esq.