FDA recalls 500 medicines; low cost can mean unsafe manufacturing


Manufacturing prescription medication in developing economies can save money but can also lead to recalls. Image: Flickr / swimboy1 / CC-BY

In an unusual move, the FDA has recalled 500 medicines intended to treat coughs and colds. The FDA cites untested safety and effectiveness in this recall. As this recall highlights, the cost savings from manufacturing drugs in emerging markets may not be worth the safety trade-off.

Cold and allergy medicines targeted

The FDA targets more than 500 prescription cold, allergy and cough medications in its latest recall. These drugs are from a variety of suppliers and use untested combinations of cough suppressants and decongestants. Some of these prescription medications were old enough that manufacturing companies did not have to provide information to the FDA. Other medications were simply marketed and sold without FDA approval. Some of the drugs are marketed for babies and children; the FDA does not recommend cold medication for anyone younger than 2.

The cost savings of manufactured medication

Manufacturing prescription medications can be an expensive and global proposition. In some cases, a compound is created in one country and shipped to another before it’s turned into pills. In other cases, a company will send chemical information to a manufacturing plant in another country. Emerging markets, such as India and China, have plants that report to cut costs of a drug by 20 percent to 50 percent. Especially for generic drugs, this helps cut the cost to consumers by even more. Drugs manufactured in these emerging markets, however, show a failure rate between 4 percent and 10 percent. For a $287 billion market in the United States, that translates to billions of dollars worth of drugs that do not work as advertised.

The health care investment in prescription drugs

As of Jan. 1 this year, the federal government is starting up programs that help cover even more of senior citizen’s prescription drug cost. With the government spending millions on covering prescription drugs, drug companies spending hundreds of millions on lobbying and the high cost of incorrectly manufactured medication, some wonder if prescription drugs are a smart investment. One study released in 1999, however, found that $1 spent on prescription medications saves about $4 in hospital care, on average. So despite the many problems, prescription drugs may prove to be one of the better health-care investments made, as long as the drugs taken are truly safe and effective.


National Center for Policy Analysis

Other recent posts by bryanh