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Drug quality problem grows

Tylenol is one of the most familiar and trusted brand names in America. In fact, commercials for the popular pain reliever used to proclaim: "Trust Tylenol. The pain reliever hospitals use most."

Does Johnson & Johnson's McNeil Consumer Healthcare unit still deserve our trust? In the past several months, the manufacturer has issued recalls for a wide variety of over-the-counter products, including Children's Tylenol, Tylenol Arthritis Pain Caplets and Extra Strength Tylenol Rapid Release Gels.

The number and range of recalls the company has issued in the past year suggest serious problems with quality control. Affected brands included Benadryl, Motrin, Rolaids, Simply Sleep and St. Joseph Aspirin.

An unpleasant moldy odor prompted many customer complaints last year. Some people reported related symptoms of nausea, vomiting and diarrhea. The problem was eventually traced to fungicide used at a plant in Puerto Rico, and an estimated 60 million bottles were recalled.

More recently, the company has landed in hot water because of manufacturing deficiencies at its plant in Fort Washington, Pa. A number of children's products (Motrin, Zyrtec, Tylenol and Benadryl) were recalled. Some of the products did not contain the correct amount of active ingredient, while others were contaminated. Overall, the plant did not demonstrate good manufacturing practices.

If Johnson & Johnson, one of the leaders of the pharmaceutical industry, could fall so far, what might we expect from other manufacturers? The news is not good.

According to The Gold Sheet, a pharmaceutical manufacturing periodical, 1,742 different drugs were recalled last year. That compares with 338 in 1999 (Wall Street Journal, June 11, 2010). Quality-control problems seem to be on the rise.

One of the biggest changes within the pharmaceutical industry during the past decade has been the outsourcing of both raw materials and finished products. At one time, most medications sold in the United States were made here, start to finish.

According to Food and Drug Administration Commissioner Margaret Hamburg, M.D., "Up to 40 percent of the drugs Americans take are imported, and up to 80 percent of the active pharmaceutical ingredients in those drugs come from foreign sources."

Both physicians and patients often are shocked to learn that the FDA does not monitor drugs for quality. The agency does not have the resources to inspect all the companies that make drugs for the American market.

Even more alarming, many drug companies themselves don't inspect the facilities producing their chemicals (Wall Street Journal, June 15, 2010). They are permitted to rely on paperwork that easily can be altered, although that rule may someday change.

Requiring on-site inspection would be a positive step. There are too many instances of falsified data from companies abroad. For example, according to the FDA Web site, the giant Indian generic manufacturer Ranbaxy has been accused of forging documents and fudging key information.

If the FDA has trouble ensuring the quality of a major brand like Tylenol made in the United States, it's hardly any wonder it has challenges in China, where many of today's generic drugs are manufactured. In order to report a suspected problem, visit our Web site,, so we can forward complaints to the FDA.

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