Last year, US drug recalls drastically increased cost pressures for a reason

According to the Gold Sheet, an industry magazine that analyzes the quality of drugs produced by the FDA, FDA reported that drug recalls have soared from 426 in 2008 to 1742 in 2009.

The largest number of recalls in history

A drug dispensing company called Advantage Dose has recalled more than a thousand products. Even with the elimination of Advantage Dose, which is now closed, US drug recalls still rose by 50% last year.

"Since the statistical recall of drugs started in 1988, the recalls for the past four years have ranked among the top five recalls in history," said Bowman Cox, editor-in-chief of Gold Sheet. "This is a meaningful development trend."

In 2001, drug recalls showed a rapid increase. From January to June this year, the total number of drug recalls reached 296, Cox said. "If you maintain this rate, you may reach 600 or more at the end of the year," he pointed out. "The recall rate is still very high."

Johnson & Johnson's McNeil Consumer Healthcare Company recalled Tylenol and other products in high-profile, causing concern over manufacturing quality issues.

The increasing drug recall issue has also attracted the attention of legislators. The two bills introduced this year will impose stricter supervision on the pharmaceutical industry and give the FDA the power to recall.

Omissions in manufacturing, especially generics and over-the-counter drugs, have contributed to the rise in drug recalls. The most common culprits include: the quality of raw materials, incorrect identification and packaging, and the contamination of medicines.

Increased FDA inspections of drug production facilities also led to an increase in drug recalls.

For its part, the FDA insisted that it did not find any worrying patterns in the recalls last year.

An FDA official said that the recall incident in 2009 did not increase, or that the number of products involved in the company's recall did not rise. It was only that there were more recalls for each recall incident.

“Because the circumstances of each recall are unique, it is difficult to assess whether there is any trend or increase in recalls this year,” said Philippine news spokesman Elaine Gantz-Bobo. "At this time, we did not see any trends."

Worrying reason

Numerous factors have contributed to the dramatic increase in drug recalls. One of the reasons is that after the drugs lost patent protection, drug makers scrambled to push generics into the market.

"Usually the first application company can get the largest share of new product business." Cox pointed out.

According to the data from the American Pharmaceutical Research and Manufacturers Association (PhRMA), generic drugs account for approximately 3/4 of all prescription drug sales.

Due to the hurry, drug makers sometimes do not have enough time to learn how best to manufacture drugs.

For example, Caraco Pharmaceuticals, headquartered in Detroit, announced four "tablet thickness" recalls on March 31, 2009, and an additional recall was announced on June 8 of that year; the April 19, 2009 announcement recalled that it may be contaminated. Product, Cox pointed out.

"Their applications can be approved. They make and sell drugs, but if they don't really know the best way to make drugs, problems will still arise sometime in the future," said Cox.

It is not only pharmaceutical manufacturers who have problems. There are also serious omissions when subcontracting drugs into smaller units and then reselling or distributing them to non-medical health care providers.

One such company is Advantage Dose, which is "far ahead" of last year's recall list. After the FDA examined the company’s production facilities later in 2008, the company announced as many as 1,106 recalls last year. According to the "Gold Sheet" report, the FDA inspection listed a wide range of manufacturing problems.

Cost pressure

Another reason for the rise in drug recalls is the cost reduction.

Facing fierce competition, drug makers are taking measures to reduce manufacturing investment or outsource production, said Prabir Basu, executive director of the National Institute of Pharmaceutical Technology and Education, a non-profit research institute.

"The manufacture of drugs is very expensive. To maintain adequate quality control requires a lot of investment." Basu said, "You must invest a lot."

Since generics and non-prescription drugs are not as profitable as prescription drugs, pharmaceutical companies may not invest enough resources to produce high quality, safe products.

"The United States is still the best in terms of pharmaceutical manufacturing. If we see signs of trouble, think about what is happening outside the United States," said Basu.

The "Gold Sheet" report shows that 165 of the drugs recalled in the United States last year were manufactured outside the United States, or are believed to have been manufactured in these countries, which is 58% higher than in 2008.

"Overall, I am worried about the quality of medicines," said Basu.