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CDER 2007 Update
Drug Recalls and Safety-Based Withdrawals
Recalls
In some cases, a drug product must be recalled due to a problem occurring in the manufacture or distribution of the product that may present a significant risk to public health. These problems usually, but not always, occur in one or a small number of batches of the drug. In other cases, a drug is determined to be unsafe for continued marketing and must be withdrawn completely.
Manufacturers or distributors usually implement voluntary recalls in order to carry out their responsibilities to protect the public health when they need to remove a marketed drug product that presents a risk of injury to consumers or to correct a defective drug product. A voluntary recall of a drug product is more efficient and effective in assuring timely consumer protection than an FDA-initiated court action or seizure of the product.
It should be noted that FDA has statutory authority to recall biologics and devices but not drugs. There are occasions where FDA has requested a recall and the company has refused. In those instances, FDA may decide to pursue an appropriate regulatory action.
Drug recalls in fiscal year 2007
- 136 over-the-counter drugs
- 851 prescription drugs
Click image for larger view. Accessible text.
How we coordinate drug recalls
We coordinate drug recall information, assist manufacturers or distributors in developing recall plans, and coordinate the preparation of health hazard evaluations with medical officers in the review divisions to determine the risk posed to the public by products being recalled. Recall actions are classified in accordance with the level of risk. We participate in determining recall strategies based upon the health hazard posed by the product and other factors including the extent of distribution of the product to be recalled. We determine the need for public warnings and assist the recalling firm with public notification about the recall. We also work with our field offices to conduct follow-up inspections where needed to investigate the reasons for the recall in order to mitigate the opportunity for reoccurrence.
Number of recalls by fiscal year
Different factors can affect the number of recalls in any one year. For example, one firm had more than 100 recalls in 2005, which caused a significant increase for that fiscal year. In 2007, one repacker caused over 670 recalled products. This event caused 2007 to be the highest year for recalls that CDER has recorded.
Top reasons for drug recalls in fiscal year 2007
- Correctly labeled product in incorrect package
- Temperature abuse
- Subpotent (single-ingredient drugs)
- Chemical contamination
- Impurities/degradation products
- Failed USP dissolution test requirements
- Labeling illegible
- Marketed without an approved New Drug Application/abbreviated New Drug Application
- Lack of assurance of sterility
- Label mix-up
- Stability data does not support expiration date
- Microbial contamination of non-sterile products
Safety-based drug withdrawals
In some cases, there is an intrinsic property of a drug that makes it necessary to withdraw the drug from the market for safety reasons. Because there has been concern expressed that sponsor user fees might have affected FDA decisions, the rates of withdrawal before and after user fees have been compared. The rates of safety-based withdrawals of new molecular entities are similar for the period before we collected user fees and for the period, beginning Oct. 1, 1992, after we began to collect user fees. The time periods are based on when we received an application rather than when we approved it. Beginning Oct. 1, 2003, approvals include new therapeutic biologics. Applications exempt from user fees are also counted.
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No safety-based drug withdrawals in 2006
There were no market withdrawals of drugs or biologics for safety reasons in calendar year 2006.
Safety-based drug withdrawals in 2007
As of Aug. 1, 2007, there were two market withdrawals of NMEs for safety reasons:
- Pergolide, approved in 1988, a drug used to treat Parkinson’s disease, was voluntarily removed from the market because of the risk of serious damage to patients’ heart valves.
- Tegaserod maleate, approved in 2002, a treatment for irritable bowel syndrome, was voluntarily discontinued from marketing on March 30, 2007, due to cardiovascular risk findings. While the manufacturer continued to study the drug, we announced a program to allow access to the drug by adult women under age 55 who are identified by their physicians as appropriate candidates for the drug.
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Date created: July 31, 2008 |
