February 22, 2019

Pharmaceutical manufacturer Lehigh Valley Technologies, Inc. will pay $4 million to resolve claims that it caused the submission of false claims through a scheme to avoid the payment of FDA new drug application (NDA) fees.  The FDA will waive such fees for a small business applicant submitting its first NDA, and had waived fees for Lehigh on an NDA in 2010.  Subsequently, in an effort to avoid $2 million in fees for a later NDA, Lehigh entered into agreements with two other companies to submit the NDAs and claim the fee exemptions, while Lehigh retained undisclosed control. USAO ED PA