Federal law generally requires that prescription drugs in the U.S. be shown to be both safe and effective prior to marketing. The FDA's evidence-based system of drug approval and the OTC monograph system play essential roles in ensuring that drugs are both safe and effective. For instance, during the drug approval process the applicant must demonstrate that its manufacturing processes can reliably produce drug products of expected identity, strength, quality, and purity. Furthermore, FDA's review of the applicant's labeling insures that health care professionals and patients have the information necessary to understand a drug product's risks and its safe and effective use.
The Agency has serious concerns that drugs marketed without required FDA approval may not meet modern standards for safety, effectiveness, quality, and labeling. Physicians and other healthcare practitioners, along with consumers, cannot assume that all marketed drugs have been found by the FDA to be safe and effective. For a variety of historical reasons, some drugs, mostly older products, continue to be marketed illegally in the U.S. without required FDA approval. The manufacturers of unapproved drug products have not received FDA approval and do not conform to a monograph for making over-the-counter (OTC) drugs. The lack of evidence demonstrating that these unapproved drugs are safe and effective is a significant public health concern.
Unapproved Drugs Initiative
Since the Compliance Policy Guide was published, FDA has removed numerous unapproved drug products from the market. Generally, the Agency has focused its enforcement efforts on classes of unapproved drugs or firms marketing unapproved drugs.
Marketed Unapproved Drugs and False Claims Act Activities
- Forest Laboratories (Levothroid): FDA Press Release (issued September 15, 2010)
Drug Maker Forest Pleads Guilty; Will Pay More Than $313 Million To Resolve Criminal Charges And False Claims Act Allegations
- Forest Laboratories (Levothroid): FDA Press Release (issued March 2, 2011)
Forest Pharmaceuticals To Pay $164 Million for Criminal Violations
- Healthpoint, LTC (Xenaderm): Press Release (issued April 1, 2011)
U.S. Files Complaint Against Texas-Based Healthpoint Ltd. Under the False Claims Act
- Schwarz Pharma (Deponit and Hysocyamine Sulfate ER): Press Release (issued April 28, 2010)
Schwarz Pharma Pays $22 Million to Settle False Claims Allegations Concerning Reimbursement for Unapproved Drugs