FDA update – March 7, 2011

FDA Intends to Remove Unapproved Drugs from Market

FDA announced Wednesday that the agency intends to remove certain unapproved prescription medicines intended to relieve cough, cold, and allergy symptoms from the U.S. market. The agency took action today to stop such drugs from being dispensed to patients, ordering manufacturers to remove about 500 cough, cold and allergy products from the market.

FDA wants to remove unapproved drugs from the market because of following reasons:

  • These products have not been evaluated by FDA to assure that they are safe, effective, and of good quality.
  • These products may pose unnecessary risk to consumers.
  • Some Products may have potentially risky combinations of ingredients.
  • Some products are marketed as “timed-release”—may release active ingredients too slowly, too quickly, or inconsistently.
  • FDA has also received reports that some of the products have names that look or sound similar to other products a problem that could contribute to medication errors.
  • Some of the products are inappropriately labeled for use by infants and young children.
  • Non-prescription cough and cold products should not be used for infants and children under 2 years of age because of serious and potentially life-threatening side effects.

FDA is concerned about two types of unapproved cough, cold and allergy medications, namely:

  • Products with pediatric labeling, including some marketed for use in children as young as 1 month old
  • Extended-release products.

Removing these unapproved products from the market will reduce potential risks to consumers from products that have never been evaluated by the FDA for safety, effectiveness, and quality.

FDA wants manufacturers to stop making the products within 90 days and stop shipping them within 180 days.

All drugs must have FDA approval or comply with an OTC drug monograph unless they fall into one of the following categories:

  • DESI pending,
  • OTC monograph pending,
  • Generally recognized as safe and effective (GRASE),
  • Grandfathered.

If there are any questions on these new FDA Policy please contact us via email at info@mdiconsultants.com and Ref: Unapproved Drugs.