FDA update – May 16, 2011

Letter to Lumigenix Inc. and Precision Quality DNAConcerning Direct to Consumer Advertising.

The Food and Drug Administration (FDA) regulates the promotion of pharmaceutical products.  The FDA's regulations issued under the Food, Drug and Cosmetic Act (FDCA) require that prescription drugs devices should have the following before marketing their products:

1. FDA’s approval or clearance if it is a drug, device and  biologics.

2. Should comply with OTC monographs for OTC products.

3. Comply with DTC advertising requirements under FDCA.

But if any manufacturer or company violets these requirement then FDA may send letters to manufacturers or may use their enforcement powers.

On 11th may 2011, FDA sent Letters to Lumigenix Inc. and Precision Quality DNA Concerning Direct to Consumer Advertising.

FDA cited following Reasons behind these letters:

  • Lumigenix Inc. currently marketing the Comprehensive Kit, a genetic testing service, intended to help individuals discover their genetic predisposition for 79 disease conditions such as breast cancer and take steps to maximize their health.
  • The Comprehensive Kit meets  the definition of a device as that term is defined in section 201(h) of the Federal Food Drug and Cosmetic Act.
  • FDA conducted a review of records, files and has been unable to identify any FDA clearance or approval number for the Comprehensive Kit.
  • The Precision Quality DNA is currently marketing the Precision Quality DNA, a genetic testing service, intended to help individuals understand the analysis of their DNA sequence while focusing on main target genes, such as BRCA1/BRCA2, to determine that individual’s main risk factors or likely response to a particular drug.
  • The Precision Quality DNA meets the definition of a device as that term is defined in section 201(h) of the Federal Food Drug and Cosmetic Act.
  • FDA conducted a review of records, files and has been unable to identify any FDA clearance or approval number for the The Precision Quality DNA.

Conclusion:

Genetic mapping is a new area of medical advancement that will require FDA scrutiny. It is not a clear cut path as one might think. Manufacturer should discuss whether the service they are promoting requires review by FDA or they should look weather if it is a drug, device or a OTC product and they should submit information in order to legally market the drug or device before making such claims.

For more information on these letters you can go to the following link:

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm255347.htm  or contact mdi at info@mdiconsultants.com   REF: Letters DTC.