Hiring an attorney early is cheaper than hiring one late, expert says

“Firms need to do their homework.  We have entered a new era of FDA enforcement.  They have made it quite clear that they are going deeper now.  They are not just going to check to see if you have a procedure to identify incoming raw materials, they are going to look at it those procedures are valid.  They are going to look at claims substantiations. They are going to look a NDI notifications if you need them,”​ said Wasserman, who is a partner in the firm Manatt, Phelps & Phillips.

“I know it’s self serving, but it is incredibly frustrating as a lawyer who wants to help companies to get the call when FDA is in their plant or when the warning letter has arrived,”​ he said.

“It’s easily three or four times as expensive to go into FDA to negotiate a settlement.  At that point you are not just talking about legal fees, but you may be talking about product recalls.  The most recent warning letter resulted in a massive recall and millions of dollars of product being destroyed,”​ he said.