FDA Removes from Market Unapproved Cough and Cold Prescription Products - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

FDA Removes from Market Unapproved Cough and Cold Prescription Products


ePT--the Electronic Newsletter of Pharmaceutical Technology

FDA announced on Mar. 2, 2011, that it is taking action against companies that manufacture, distribute, or market certain unapproved prescription oral cough, cold, and allergy products, according to an agency release and press briefing.

FDA’s Office of Compliance Director Deborah M. Author explained in a press briefing that the legal requirements for evaluating and approving prescription drugs have changed over the past century, including the enactment of the Food, Drug, & Cosmetic Act, and that, still, many drugs have remained on or entered the market illegally.

This class of drugs is of particular concern because many of these products are labeled as “timed release,” which are complicated to manufacture. It is important, said Author, that FDA review these types of drugs to ensure that the release of the active ingredient is occurring at the right time and in the right dosage. This class of drugs is also important because many of the products are labeled for children age 2 and under. In 2008, the agency called for the relabeling of over-the-counter cough, cold, and allergy medications for children under age 2 because of potential serious side effects.

According to the agency press release, “Unapproved prescription cough, cold, and allergy drug products have not been evaluated by the FDA for safety, effectiveness, and quality. People may be at greater risk when using these products than when using FDA-approved prescription drugs or drugs that are appropriately marketed over-the-counter.” 

The action, which is part of FDA’s 2006 unapproved drugs initiative, calls for companies that have previously listed products subject to FDA’s action to stop manufacturing the products within 90 days and to stop shipping the products within 180 days.  In addition, companies that have not previously listed products subject to today’s action with FDA are asked to stop manufacturing and shipping their products immediately. The overall initiative has prompted the removal of 550 unapproved products from the market in the past five years. This latest action affects 500 unapproved prescription products.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
23%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
7%
All of the above.
47%
No government involvement in patient treatment or drug development.
9%
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here