Generic Drug – Generic drugs are chemically equivalent, to drugs that have already been approved by the FDA. Most generic drug names reflect the chemical name of the drug. These drugs are less expensive, yet have the same therapeutic value. See also Abbreviated New Drug Application Fraud (ANDA) in this Glossary.
Generic Drug Fraud – See Abbreviated New Drug Application in this Glossary.
GMP Fraud – See Good Manufacturing Practices Fraud in this Glossary.
Good Manufacturing Practices (GMP) Fraud – involves fraud with the Good Manufacturing Practice Regulations which require manufacturers to have adequately equipped manufacturing facilities, adequately trained personnel, stringent control over the manufacturing process, appropriate laboratory controls, complete and accurate records, reports, appropriate finished product examination, and so on. Certain violations of the Good Manufacturing Practice Regulations may be the basis for a False Claims Act lawsuit.
GPO Kickbacks – See Group Purchasing Organizations kickbacks in this Glossary.
Group Purchasing Organizations kickbacks (“GPOs”) – these are for-profit companies that consolidate the purchasing power of a large group of separate entities and leverage the volume to negotiate contractual discounts from national suppliers of pharmaceutical and other health care products. Members of the GPOs benefit by discount prices. Most hospitals are members of a GPO. GPO’s have been the subject of several kickback investigations. Related questions to ask include, are the rebates paid by the GPO (such as McKesson, Amerisource Bergen, Cardinal Health, Owens and Minor) properly identified as purchase credit rebates as a separate line item in their hospital client Medicare cost reports?