Big Pharma Says Jump And The FDA Says How High?

by Long Island Attorney Paul A. Lauto, Esq.

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.

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