Parija Kavilanz in an August 16 CNNMoney story, writes about the incredible surge in recalls of prescription and over-the-counter drugs which is raising questions and concern regarding the quality of drugs within the United States’ supply chain.
This excellent article contains statistics, industry expert quotes and examples of a problem that is impacting both industry giants and small pharmaceutical companies. Ultimately drug recalls are impacting the overall health and well being of the average consumer.
The CNNMoney story accurately encapsulates a very real global pharmaceutical industry issue that is impacting the lives and overall health of the domestic population.
According to the story:
• 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."
The issue is not limited to small manufacturers, high-profile recalls of Tylenol and other popular over-the-counter brands from McNeil Consumer Products, a unit of Johnson & Johnson, have drawn significant scrutiny because of quality concerns in pharmaceutical production.
Also in the CNNMoney story:
• 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.
• 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."
Kavilanz, in the story attributes several factors to this surge, including the speed of drugmakers to bring generic versions of branded drugs and cost cutting pressures of these manufacturers, including lack of total oversight of the product as they outsource production and raw materials increasingly from overseas.
• 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.
• 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.
• 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."
• "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.
CNNMoney, with it first-rate story with great industry insight, highlights an industry issue that has the potential to create a huge health care issue. As the pharmaceutical supply chain continues to globalize not only will quality control issues continue to proliferate but the issue of fraudulent, adulterated and counterfeit medications also penetrating into the legitimate supply, will escalate as well.
Secure Pharma Chain, encourages all members of the pharmaceutical supply chain and regulatory agencies, to embrace and deploy authentication technologies that verify the efficacy and quality of products within their sealed unit-of-sale container.
Current industry solutions and methods of tracking the pedigree and serialization track the product’s transaction through the supply chain do nothing to protect the consumer from poor quality, fraud, adulteration and counterfeit pharmaceutical product.
Understanding and verifying the authenticity and quality of the end use product to the consumer is vital in protecting both the industry and well being of the population.
To read the entire CNNMoney story, online, visit: http://money.cnn.com/2010/08/16/news/companies/drug_recall_surge/index.htm?hpt=T2.
To learn more about authentication solutions for the pharmaceutical supply chain, visit: http://www.xstreamsystems.net/.