FDA update – March 29, 2011

Pharmaceutical Fraud Pilot Program

The Department of Health and Human Services’ Health Care Fraud and Abuse Control Program have came up with a new Report which is boasting numerous high-profile accomplishments about PFPP (PFPP is a little known and modestly funded program, the FDA Pharmaceutical Fraud Pilot Program).

The high profile accomplishments are as follows:

Recovery of more than $4 billion in FY 2010; expansion of HEAT, the Health Care Fraud Prevention & Enforcement Action Team, partnerships; and a return on investment of almost $7 for every $1 spent.

Billed as an effort to detect, prosecute and prevent FDA-related health care fraud, the PFPP promises to focus on fraudulent marketing schemes, application fraud, clinical trial fraud and manufacturing related FDCA violations.

Predictably, PFPP will handle the investigation and prosecution of off-label promotion of pharmaceuticals and medical devices.

Receiving a mere $1.7 million in funding for FY 2010, the FDA PFPP has opened significant Criminal investigations, including:

• Two off-label promotion matters involving different manufacturers of brand name prescription drugs;
• Two matters involving manufacturing fraud associated with current Good Manufacturing Practice issues, one of which also involves potential application and promotional fraud;
• A clinical trial fraud matter where study documents are alleged to have been falsified; and
• A Contract Testing Laboratory company that allegedly falsified data used to support multiple drug applications.

The PFPP is expanding quickly: hiring new personnel, establishing relationships with criminal
Investigators and regulatory components of the FDA, and reaching out to United States Attorneys’ Offices. FDA also has established a training plan to implement the PFPP.

At this point, it is difficult to see how FDA’s PFPP differs materially from other fraud enforcement initiatives underway. In 2010, the Department of Justice opened more than 1,100 new criminal health care fraud investigations and federal prosecutors had over 1,750 health care fraud criminal investigations pending. DOJ also opened in 2010 almost 950 civil health care fraud investigations and had more than 1,250 related civil matters pending at the end of the year.

The PFPP likely will result in more investigations stemming from FDA inspections and other oversight activities, rather than from whistleblowers and data-mining expeditions.

If there are any questions on this new pilot program please contact us via email at info@mdiconsultants.com and Ref: PFPP.