DESI Drugs

Serving Clients Nationwide

The 1938 Federal Food, Drug, and Cosmetic Act gave authority to the Food and Drug Administration to regulate prescription drugs and to prohibit the sale of drugs not determined to be safe. However, in 1962, Congress amended this law to require all new drugs to be certified by the FDA as both “safe and effective” after review of valid scientific studies. Drugs which had been previously approved as “safe” prior to 1962 were required to be studied for effectiveness by the Drug Effectiveness Study Implementation program (DESI).

If DESI does not find substantive evidence that a drug is effective for each labeled indication, it is considered “less-than-effective” and recommended for removal from the market by the FDA. However, FDA also releases a Notice of Opportunity for a hearing to prove the drug’s effectiveness along with any drugs “identical, related, or similar” (IRS) to the drug in question. If the original or “identical, related, or similar” drugs are then determined by the FDA to be effective, the manufacturer must still submit a New Drug Application (NDA) for final approval.

With very few exceptions, any DESI drug (including identical, related, or similar drugs) that has not been approved after submission of an NDA is still considered “less-than-effective” and subject to FDA enforcement action at any time. Even if the FDA’s hearing judgment affirms a DESI drug’s effectiveness, marketing of that drug or its IRS counterparts remains illegal until an NDA is submitted and approved.

DESI Drugs and Medicaid Fraud

Marketing of DESI drugs and their IRS counterparts without final FDA approval is illegal, but because the FDA’s resources are limited, some unapproved DESI drugs remain on the market. Because these drugs are not approved by the FDA, they are not considered Covered Outpatient Drugs by Medicaid and are not eligible for government reimbursement claims. Thus, the marketing of unapproved DESI drugs that end up being paid for by Medicaid is considered pharmaceutical fraud under the False Claims Act.

If you have knowledge that a pharmaceutical company or other entity is involved in marketing an unapproved DESI drug or a drug IRS to it, your knowledge may enable you to become a whistleblower by bringing a qui tam lawsuit. The role of whistleblowers in reporting illegal marketing of DESI drugs is to protect the public from unsafe or ineffective drugs, an important public safety concern. In addition, whistleblowers who report DESI drug pharmaceutical fraud can recover millions of wasted taxpayer dollars for the government and even receive a significant percentage of the recovered amount as a whistleblower reward.

At Kenney & McCafferty, we focus our practice almost entirely on qui tam whistleblower lawsuits because we believe in the importance of eliminating fraud and protecting the public interest. Our experienced qui tam attorneys have been protecting whistleblowers and uncovering fraudulent acts nationwide for over fifteen years. Our experience and dedication makes us exceptionally qualified to handle your qui tam action and to protect your rights as a whistleblower under the provisions of the False Claims Act.

If you have knowledge of fraud or a false claim against the government, please contact our qui tam lawyers today. Kenney & McCafferty attorneys will consult with you about your case, without obligation. All communications with Kenney & McCafferty attorneys during these consultation services are confidential and protected by the attorney-client privilege.