In 1962, Congress amended the Federal Food, Drug and Cosmetic Act to provide greater regulation of drugs sold in the United States.
Nolan Auerbach & White is an experienced Pharmaceutical Fraud Law Firm helping courageous whistleblowers.
All new drugs must be shown by adequate studies to be both “safe and effective” before they can be marketed. Drugs approved as merely “safe” prior to 1962 (i.e. those approved between 1938 and 1962) had to be reviewed as to their effectiveness under the Drug Efficacy Study Implementation (”DESI”) program. A DESI review of over 3,400 drugs that entered the market between 1938 and 1962 was undertaken in the 1960s and 1970s. If the DESI review indicated a lack of substantial evidence of a drug’s effectiveness for all of its labeled indications, the FDA published a Notice of Opportunity for a hearing concerning its proposal to withdraw approval of the drug for marketing. A manufacturer of that drug, or drugs “identical, related or similar” (”IRS”) to that drug, could request a hearing and attempt to provide evidence of the drug’s effectiveness. Drugs for which a Notice of Opportunity for hearing has been published are referred to as “less-than-effective” (”LTE” or “DESI-LTE”) drugs until they receive FDA approval. The IRS counterpart of a DESI-LTE drug is also considered less than effective. “DESI drugs” and “Less Than Effective” drugs are not Covered Outpatient Drugs under the Medicaid program.
There are still hundreds of DESI drugs on the market. The sale of unapproved drugs is illegal. See FDA’s Final (2006) Marketed Unapproved Drugs – Compliance Policy Guide.
Kathleen Hawkins, RN MSN, had been employed by Defendant, Catholic Healthcare West (CHW) for approximately 6 years when she decided she had had enough of trying to change the hospital system from within.
CHW, a California not-for-profit corporation that operated hospitals in California, Arizona, and Nevada, was at the time the eighth largest hospital system in the nation and the largest not-for-profit hospital provider in California.
Joe Strom contacted us in 2005. We were very grateful that he did. We immediately formed an all-star legal team and a process to stop a very harmful pharmaceutical marketing strategy. It was this process we set into motion that ultimately returned hundreds of millions of dollars to the U.S. Treasury, and a portion of that, very well-deserved, into Joe’s bank account.
Joe told us a very troubling story about the off-label promotion of a pharmaceutical drug for patients who already suffered from chronic heart failure.
Bruce Moilan was a seasoned hospital systems expert by the time he contacted our Firm. At the time he decided to file his qui tam lawsuit, he was employed by South Texas Health System as a System Director for Materials Management. In this position, he oversaw $24 million in annual purchases of supplies and equipment and helped determine budget, reduction and cost analysis throughout the contract bidding and negotiations process. His job was to insure proper implementation for purchasing, receiving and management of inventory, for McAllen Hospitals, L.P.