On September 15, the U.S. Department of Justice announced that a qui tam, or whistleblower, lawsuit led to a $7.9 million settlement with Akorn Operating Company LLC, a pharmaceutical company. Akorn settled claims “that it caused the submission of false claims to Medicare Part D, in violation of the False Claims Act, for three generic drugs that were no longer eligible for Medicare coverage.” The whistleblower in the case will receive a $946,000 award for their role in the case.
The qui tam provisions of the False Claims Act enable private citizens to file lawsuits on behalf of the government if they know of an individual or company defrauding the government. Qui tam whistleblowers are eligible to receive between 15 and 30% of the government’s recovery, if one occurs. In this case, the U.S. government intervened in the whistleblower’s case and conducted the investigation.
According to the press release, Medicare Part D reimburses “FDA-approved ‘prescription only’ (Rx-only) drugs” but not “over the counter” (OTC) drugs. OTC drugs “may be purchased by retail customers without a prescription and are not reimbursed by Medicare Part D.” The DOJ explains that a company can “seek to fully convert a brand-name Rx-only drug to an OTC drug” if the FDA approves the switch. After the FDA approves the change, “the drug is no longer considered an Rx-only product and makers of generic equivalents are then required either to seek FDA approval for their own OTC switch or to seek...
Congress leaders Harshwardhan Sapkal and Nana Patole, Nationalist Congress Party (SP) legislator Rohit Pawar, and Shiv Sena (Uddhav Balasaheb Thackeray) leader Priyanka Chaturvedi said PM Modi's sp...