Drug recalls surge

chart_drug_recalls2.top.gifDrug recalls hit a new record in 2009, with one company accounting for more than 1,000 of them. By Parija Kavilanz, senior writer


NEW YORK (CNNMoney.com) -- Recalls of prescription and over the counter drugs are surging, raising questions about the quality of drug manufacturing in the United States.

The Food and Drug Administration reported more than 1,742 recalls last year, skyrocketing from 426 in 2008, according to the Gold Sheet, a trade publication on drug quality that analyzes FDA data.

One company, drug repackager Advantage Dose, accounted for more than 1,000 of those recalls. Even excluding Advantage Dose, which has shut down, recalls jumped 50% last year.

"We've seen a trend where the last four years are among the top five for the most number of drug recalls since we began tallying recalls in 1988," said Bowman Cox, managing editor of the Gold Sheet. "That's a meaningful development."

The fast pace of drug recalls seems to be continuing in 2010. Drug recalls totaled 296 from January through June of this year, said Cox. "If we continue at this same rate, we could get 600 or more recalls by the end of the year," he said. "That's still a very high rate of recalls."

High-profile recalls of Tylenol and other products by McNeil Consumer Healthcare, a unit of Johnson & Johnson (JNJ, Fortune 500), have drawn attention to quality concerns in manufacturing.

The mounting problems over recalls have also drawn attention from lawmakers. Two bills introduced this year would impose stricter regulations on the industry and give the FDA authority to mandate recalls.

The spike in recalls, especially of generic and over-the-counter drugs, is being driven by manufacturing lapses, experts say. Some of the biggest culprits: the quality of raw materials, faulty labeling and packaging and contamination.

Increased FDA scrutiny of drug production facilities may also be triggering recalls.

For its part, the FDA maintains that it hasn't identified any alarming patterns in last year's recalls.

An FDA official told the Gold Sheet that 2009 saw no increase in recall "incidents" -- or recalls involving one product problem at a company -- just more recalls per incident.

"Since every recall situation is unique, it would be difficult to assess whether there are any trends or increases in recalls this year," FDA spokeswoman Elaine Gansz Bobo told CNNMoney. "At this time, however, we have not identified any trends."

Cause for concern

A number of factors are fueling the recall surge. The stampede by drugmakers to be first to bring generic versions to market, after drugs lose patent protection, is one of them.

"The first applicant typically gets the lion's share of the business for the new drug," said Cox.

Generic drugs account for about three quarters of all prescription drug sales, according to industry group PhRMA.

In their hurry, drugmakers sometimes fail to spend enough time time learning how best to make the drug.

For example, Detroit-based Caraco Pharmaceutical Laboratories issued four "tablet-thickness" recalls on March 31, 2009, an additional one on June 8 and yet another recall on April 17 for products that might have been contaminated, said Cox.

"So they get the application. They make and market the drug, but they could still have problems down the road if they haven't really understood the optimum way to make that drug," said Cox.

Caraco could not be reached for comment.

Drugmakers aren't the only ones that have run into problems. Repackagers that relabel drugs into smaller units for resale or distribution to health care facilities, have also had serious lapses.

Advantage Dose, which led last year's recalls by far, is one such company. It issued 1,106 recalls last year following the FDA's inspection of its facility in late 2008. According to the Gold Sheet report, the FDA's inspection listed a wide range of manufacturing problems.

Cost pressures

Another reason for the recalls: Cost cutting that goes too close to the bone.

Drugmakers, facing intense competition, are trimming manufacturing investment or outsourcing production, said Prabir Basu, executive director of the National Institute for Pharmaceutical Technology and Education, a nonprofit scientific and research organization.

"It is very expensive to make drugs. It also costs a lot of money to maintain adequate quality controls," Basu said. "You have to invest a lot."

And since generic and over the counter drugs aren't as lucrative for drugmakers as prescription drugs, companies may not be investing enough resources to make high-quality, safe products.

"We still have the best at drug manufacturing here in the United States. But if we're seeing signs of trouble, imagine what's happening outside of the U.S. in other countries from where we import drugs," said Basu.

The Gold Sheet report said that 165 recalls last year were of products made, or believed to be made, abroad. That was up 58% from 2008.

"Overall, I am concerned about the quality of drugs," said Basu. To top of page

Just the hot list include
Frontline troops push for solar energy
The U.S. Marines are testing renewable energy technologies like solar to reduce costs and casualties associated with fossil fuels. Play
25 Best Places to find rich singles
Looking for Mr. or Ms. Moneybags? Hunt down the perfect mate in these wealthy cities, which are brimming with unattached professionals. More
Fun festivals: Twins to mustard to pirates!
You'll see double in Twinsburg, Ohio, and Ketchup lovers should beware in Middleton, WI. Here's some of the best and strangest town festivals. Play
Index Last Change % Change
Dow 32,627.97 -234.33 -0.71%
Nasdaq 13,215.24 99.07 0.76%
S&P 500 3,913.10 -2.36 -0.06%
Treasuries 1.73 0.00 0.12%
Data as of 6:29am ET
Company Price Change % Change
Ford Motor Co 8.29 0.05 0.61%
Advanced Micro Devic... 54.59 0.70 1.30%
Cisco Systems Inc 47.49 -2.44 -4.89%
General Electric Co 13.00 -0.16 -1.22%
Kraft Heinz Co 27.84 -2.20 -7.32%
Data as of 2:44pm ET
Sponsors

Sections

Bankrupt toy retailer tells bankruptcy court it is looking at possibly reviving the Toys 'R' Us and Babies 'R' Us brands. More

Land O'Lakes CEO Beth Ford charts her career path, from her first job to becoming the first openly gay CEO at a Fortune 500 company in an interview with CNN's Boss Files. More

Most stock quote data provided by BATS. Market indices are shown in real time, except for the DJIA, which is delayed by two minutes. All times are ET. Disclaimer. Morningstar: © 2018 Morningstar, Inc. All Rights Reserved. Factset: FactSet Research Systems Inc. 2018. All rights reserved. Chicago Mercantile Association: Certain market data is the property of Chicago Mercantile Exchange Inc. and its licensors. All rights reserved. Dow Jones: The Dow Jones branded indices are proprietary to and are calculated, distributed and marketed by DJI Opco, a subsidiary of S&P Dow Jones Indices LLC and have been licensed for use to S&P Opco, LLC and CNN. Standard & Poor's and S&P are registered trademarks of Standard & Poor's Financial Services LLC and Dow Jones is a registered trademark of Dow Jones Trademark Holdings LLC. All content of the Dow Jones branded indices © S&P Dow Jones Indices LLC 2018 and/or its affiliates.