Archive for FDA

Law & Order – NBC Episode on counterfeit asthma inhaler

February 20, 2008 at 9:57 pm · Filed under California e-Pedigree, FDA, fake drugs ·Tagged , , , , ,

Even producers of Law & Order appreciate the impact of counterfeit drugs.

A Park Avenue dentist is murdered and evidence points to his young patient. Wednesday, February 20, 2008 at 9PM. 

An episode of a series of murders related to counterfeit drugs. The fictitious Shore Labs drug producer that manufactures an asthma inhaler as well as a mouthwash, Snow-Mint, that are tainted with DEG.

The FDA inspector discovers the tainted mouthwash at a dollar store and reports to his FDA supervisor, Leslie Lezard.

The FDA Deputy Director, Atlantic Division, covers up the tainted mouthwash by conspiring with the drug producer to avoid recalls.

The FDA Deputy Director was a former drug lobbyist and college ‘buddy’ of the drug producer, Bing Shore.

3 children dead. 2 adults dead.

The only thing missing in the episode was a letter from Shore Labs to the California Board of Pharmacy requesting a delay to January 2011 for e-Pedigree compliance.

Leave a Comment

Drug Makers Want to Extend Deadline for Drug Tracking

February 19, 2008 at 8:48 pm · Filed under California e-Pedigree, FDA, Internet drugs, compliance packaging ·Tagged , , ,

Drug Makers Want to Extend Deadline for Drug Tracking
By HEATHER CHAMBERS - 2/4/2008
San Diego Business Journal Staff

A decision that could delay safeguards for prescription drugs in California is approaching, causing a divide between those who say immediate action is needed to protect patients and drug companies that say a system is not yet ready for implementation. The state Board of Pharmacy, which gathered public comments locally in January, will consider delaying a requirement that prescription drug makers, packagers, wholesalers and pharmacists use an electronic tracking system capable of tracking drugs from manufacturer to consumer.

Currently, those involved in the supply chain — from manufacturer to distributor to pharmacy — will have to provide documentation, or an electronic pedigree, for every prescription drug that moves through the state beginning Jan. 1, 2009.

The state Legislature enacted a law sponsored by the pharmacy board in 2004 requiring the changes by 2007, but extended the deadline to 2009 after drug makers and others expressed concerns about meeting the earlier deadline.

The regulations are part of an effort to protect state residents from ingesting counterfeit, damaged, adulterated or misbranded products.

“We see this as our principal initiative this year. We will continue to work with the industry to get them to comply,” said Virginia Herold, executive officer of the pharmacy board.

She said the agency grapples with balancing the need for consumer protection with a safe and secure drug supply. The board could decide as early as April, though Herold said it could also postpone a decision until later this year.

Pushing Deadline

Lobbying groups for pharmaceutical, biotechnology and pharmacy industries are pushing to extend the deadline to 2011, contending that they require more time to put systems in place. Most have been testing radio frequency identification, known as RFID, and two-dimensional bar coding technologies.

But large biotech and pharmaceutical companies cited the complexities involved in getting compliance from third-party contract manufacturers, which are scattered throughout the country. Smaller drug companies said compliance would require expensive authentication equipment, placing financial burdens on their small operations.

About 50 drug companies and related agencies sent letters to the state board updating their progress on complying with the Jan. 1, 2009, deadline. All but two said they would need more time to meet the deadline.

EMD Serono Inc. estimated that it will spend an initial $2.2 million in packaging and serialization costs to implement changes. Johnson & Johnson estimated that it would cost the company more than $100 million to fully comply. Others, such as Biogen Idec, stressed their companies had just reached the planning stages and wouldn’t be ready by Jan. 1.

“The problem of adulterated products getting into the supply chain is a very serious one,” said Robert Hamm, Biogen Idec’s executive vice president of pharmaceutical operations and technology, in an e-mail. “We want to ensure that there is time to put the proper systems in place before implementing this initiative so patients don’t face any delays or disruptions in getting their medications.”

Jim Dahl, a former assistant director of the FDA’s Office of Criminal Investigations who has testified before Congress as an expert witness on drug counterfeiting, said he supports keeping the deadline intact because immediate implementation would benefit consumers and keep fake drugs from entering the marketplace.

Illegal Sale

One common scheme, he said, involves the illegal sale of prescription drugs to hospitals and nursing homes at a steep discount off wholesale prices. Others have taken advantage of supply shortages.

Last year, a man identified as Mahmoud Abu Arqoub was convicted in the U.S. District Court in New Jersey for smuggling, mail fraud, misbranding and selling unapproved drugs without a license. Arqoub offered to sell a New Jersey hospital 20,000 doses of the flu vaccine Vaxigrip for $65 a unit during a time when the flu vaccine was in short supply. The average wholesale price of a common flu vaccine was about $7 a unit at the time.

“It’s lying, cheating and stealing and using interstate commerce to figure that in,” Dahl said.

Dahl commended the board’s efforts in encouraging companies to comply with electronic tracking, but said more aggressive measures would take time.

“The biggest problem with implementation of the California law is that they also require serialization,” he said.

Individualizing products by serial number requires costly authentication equipment, said Dahl. He broached the idea of keeping the electronic pedigree system deadline in place for 2009 but delaying the use of serial numbers until 2011.

Dahl said the Internet also poses unique challenges in tracking counterfeit drugs. Often, Internet schemes involve drugs trading hands multiple times worldwide.

“The Internet is the wild, wild West,” Dahl said. “There are only a handful of domestic Internet pharmacies that are legitimate.”

San Diego’s proximity to the U.S.-Mexico border also poses a significant problem because regulations are rarely enforced in Mexico, he said.

Motorola Inc. and BA Systems have been testing a system capable of reading all RFID tag frequencies and capturing data without the need for special computing devices.

Others have studied holograms, color-shifting dyes and numerous other anti-counterfeiting technologies.

Bryan Liang, a law professor and executive director of the Institute of Health Law Studies at California Western School of Law and program director for the San Diego Center for Patient Safety at UC San Diego, said he’s looking forward to seeing more advanced drug tracking technologies.

“We need efforts to track the drug, not the cardboard,” he said.

Liang added that even if tracking systems were 99 percent accurate, the remaining 1 percent would leave a worrisome amount of drugs in question.

“Technology has a huge advantage; it allows us to track it if it works right,” he said. “If it doesn’t work right and we don’t have operability from one person to another, we’re going to have a problem.”

http://www.sdbj.com/print.asp?aid=16320887.5797893.1582841.7749563.2621482.999&aID2=121748

Leave a Comment

Fact 12: California Drug Pedigree – “Compliance packaging”

February 12, 2008 at 10:20 am · Filed under California e-Pedigree, FDA, compliance packaging, packaging line ·Tagged , ,

“Compliance Packaging” will be the key to meeting the January 2009 California pedigree deadline. 

 For California Pedigree compliance there are 3 terms that are important to remember:

- Contract packaging

- Re-packaging

-  Compliance packaging

Generally, contract packaging is a service provided by a third party to a drug company. Drug firms outsourcing packaging look to contract packagers to optimize the supply chain costs and help quickly deliver finished product into the marketplace.

To meet these requirements, wholesalers and contract packagers have expanded services well  beyond traditional services such as material selection and testing, and component assembly. Some contract packagers have evolved to turnkey packagers. In these partnerships, contract packagers often manage supply chain resources, purchase packaging materials, and manage finished inventory to ensure just-in-time delivery.

Re-packaging, is the function where a drug is re-branded. This is where the packager takes an existing branded or generic drug and either re-brands it as a private label, or constructs a kit containing a branded drug.

Both contract packagers and re-packagers operate under FDA guidelines, although the guidelines may differ. 

With the California Pedigree requirements, there is a new role in packaging…“Compliance Packaging.” 

For California Pedigree, those drug companies that invested in pedigree applications and serialization pilot lines have been focused on conversion of their packaging line to serialize 100% of their US destined production.

In reality, for every bottle of drugs that is required to be compliant with California SB1307 and SB1476, 9 other bottles on the same packaging line are serialized, even though they are destined to States that do not mandate item level serialization.

Now enters a new opportunity for contract packagers and wholesalers, to become “Compliance Packagers.” 

Imagine for a moment that a contract packager has a 200,000 square foot building in Reno, Nevada.  In the building, the contract packager invests in a serialization packaging line specifically for a drug manufacturer. Let’s call it ‘ABC Drugs.’

ABC Drugs, takes 6-9% of their production output and ships it to the “Compliance Packager.”  The Compliance packager opens the cases on the dedicated serialization packaging line, takes out the bottles, applies serial numbers to the bottles using datamatrix, or RFID, and returns the bottles to the same case. The case is serialized. Now the case is 100% compliant with California item serialization.

This “Compliance Packaging” is actually outside the FDA packaging guidelines. In many respects there is no difference between the process, as it relates to the FDA, than the services offered by a transportation company.

Who are the biggest potential winners in the role of “compliance packagers” ?

- Cardinal 

- Abbott

- Baxter 

- McKesson

- Amerisource

In addition, the majority of large drug manufacturers offer contract packaging to smaller drug producers. 

For the top 20 drug producers, 2 or 3 compliance packaging lines will meet the California Pedigree requirements.

For the next 50 drug companies, in size, 1 compliance packaging line will be more than adequate.  

 The capital investment, installed, is approximately $150,000 per line, for the first line, and $75,000 for subsequent lines. This is a turnkey line with conveyors, in-line printers, label applicator, CCTV security, vision cameras, RFID readers, accumulators and a turnkey software solution.

A 5 line shop, turnkey hardware and software, is $450,000. 

A single line can output 800 cases in an 8 hour shift. The ROI is 90-120 days after depreciation. 

Are we experiencing a new pharma business category, the “compliance packager” ?

If you’d like to find ”Compliance Packagers”, or you’d like to simply get support with an RFP, simply comment on the blog. (Tell us if you want to be unpublished and your comment will not be posted). 
 

Leave a Comment

Fact 8 – Counterfeit drugs

February 6, 2008 at 11:04 am · Filed under California e-Pedigree, FDA, Internet drugs, fake drugs ·Tagged , , ,

The global prescription drug market is $600 Billion / year.

Combined branded and generic drugs, this represents 200 Billion pills, capsules and tablets.

According to World Health Organization (WHO) 5% of global consumption is counterfeit.

That’s an estimated 10 Billion pills, capsules and tablets a year.

In an Indianpolis Star article, January 2008, Lilly spokesman stated that 3 million pills, capsules and tablets were seized globally as counterfeit or suspected counterfeit drugs. That’s 1.5 million a year.

If 10 Billion pills, capsules and tablets of prescription drugs are counterfeit according to the WHO, and 1.5 million are seized by law enforcement, where are the 9,998,500,000 counterfeit prescription drug pills every year ?

If California represents 10% of the USA market, which is 5% of the global market, those are 500 million counterfeit pills, capsules and tablets  consumed in California every year ?

Please send us your comments. 

Leave a Comment

Pharmacist Convicted in 2006 of Purchasing Chinese Counterfeit Drugs

February 6, 2008 at 10:00 am · Filed under FDA, fake drugs ·Tagged , ,

Pharmacist, independent drug store, Convicted in 2006 of Purchasing Chinese Counterfeit Drugs

HOUSTON, TX — James George, a licensed pharmacist, was convicted by a jury’s verdict of conspiracy to introduce in interstate commerce counterfeit and misbranded pharmaceutical drugs and trafficking in counterfeit drugs from China. United States Attorney Don DeGabrielle noted that the jury deliberated less than two hours before finding George guilty on all six counts alleged in the indictment. The verdict was returned on May 24, 2006.

At sentencing, which is scheduled for July 7, 2006, George faces a maximum of five (5) years imprisonment for the conspiracy conviction, three (3) years for the misbranding conviction, three (3) years each for the two counterfeiting of pharmaceutical drugs convictions and 10 years each for trafficking in counterfeit goods convictions. George also faces fines of $250,000 for the conspiracy count, $10,000 each for the misbranding and counterfeiting of pharmaceutical drugs, and $2,000,00 for each trafficking in counterfeit goods conviction.

During the two-day trial, the United States presented evidence showing that on November 5, 2004, Immigration and Customs Enforcement (ICE) inspectors at the Dallas Fort Worth Airport examined a large package that had arrived from China with shipping documents identifying its contents as health food. However, inspectors found large quantities of the pharmaceutical drugs Viagra and Cialis, instead. ICE special agents assigned to the airport were notified of the discovery.

Suspecting the pharmaceutical drugs were counterfeit, ICE agents notified Pfizer Pharmaceuticals, the manufacturer of Viagra, to verify the authenticity of the drugs. Checking the lot numbers, Pfizer confirmed the drugs were counterfeit. Eli Lilly, the manufacturer of Cialis, also confirmed the Cialis tablets were counterfeit.

Agents then turned their attention to identifying the person who ordered the counterfeit drugs. The address of the invoice indicated the package was being shipped to 16422 Concord Falls Lane, Sugarland, Texas. After making several inquiries, agents determined the address listed on the invoice and shipping documents was the home of James George, a licensed pharmacist in Houston, Texas. Agents also determined that George was the owner of LIFEWAY PHARMACY, which was located on the 1300 block of Holland Ave, Suite D, in San Jacinto, Texas.

ICE agents secured the assistance of the Food and Drug Administration (FDA) in Dallas and Houston, and arranged for a “controlled delivery” of the counterfeit drugs to George. On December 9, 2004, an FDA agent posing as an employee of a delivery company contacted George by telephone, asking whether he would accept delivery of the package he ordered from China. George told the undercover FDA agent he was expecting a package containing health products, such as vitamins, and agreed to accepted delivery at his pharmacy.

On December 13, 2004, an FDA undercover agent met with George at his pharmacy and delivered the package containing 1,000 counterfeit Cialis tablets and over 4,500 Viagra counterfeit tablets. George was asked to look inside the package to confirm that it contained the merchandise he had ordered from China. After signing a document confirming his receipt of the package, George was advised of the identity of the FDA agent. When confronted by the agent as to why he was importing drugs from China, George told the agent then, and told the jury during trial, that he did not know the drugs were counterfeit and had planned to send the drugs to Nigeria.

Testimony proved that the average wholesale price for Viagra tablet is $9.55 and that George ordered the drugs from China over the internet from Joyce Zhen, who was identified at trial as the co-conspirator, for 30 cents a tablet. The jury was also informed that the average wholesale price for a Cialis tablet is $13.55, and that George paid 35 cents for each tablet of the counterfeit drug.

This case is the result of the investigative efforts of the U.S. Immigration and Customs Enforcement field offices in Dallas and Houston, and the Food and Drug Administration, Office of Criminal Investigations in Dallas, Austin and Houston, and the invaluable assistance of Pfizer and Eli Lilly pharmaceutical companies. This case is being prosecuted by Assistant United States Attorneys Samuel J. Louis and Stuart Burns.

May 25, 2006

U.S. Department of Justice
Southern District of Texas
Donald J. DeGabrielle, Jr.
United States Attorney
John Yembrick
Public Information Office
(713) 567-9388 

Leave a Comment

Before you buy a drug online

February 4, 2008 at 4:38 pm · Filed under FDA, Internet drugs, fake drugs ·Tagged , ,

1- If you received an unsolicited email, the probability is extremely high the drugs you may order is fake.

2 – If you receive a mailer or a referral from a friend, contact your State Board of Pharmacy to validate the legitimacy of the Internet site. A list of Boards of Pharmacy is attached, National Association of Boards of Pharmacy, National Association of Boards of Pharmacy or can be found at http://www.nabp.net/whoweare/boards3.asp

Many Internet Drug companies are getting around mail fraud risk by using community newspapers to deliver inserts. These are the newspapers that are delivered to your home weekly for free. 

*** If you receive a mailer in the mail or an insert in a newspaper, comment on this blog anonymously and we will advise you if the company on the mailer is legitimate.***

3 – In many cases, there is a ’safe’ generic drug available through Wal-Mart, A&P, Target, etc.. for under $5 a prescription. “Call” your doctor and explain the economics and ask your doctor to help you save money with a generic before you buy on the Internet.

4- If your reason for ordering a prescription drug on the Internet is that you don’t need a prescription from a doctor, it’s generally because the visit to a doctor may be too expensive or inconvenient. Call your doctor and explain your circumstance.

5 – If you receive a drug over the Internet and you suspect it’s a fake, comment on this blog anonymously and we will provide directions to validate the prescription.

6 – We don’t need the drug to help you. You can send us the packaging that contained the drug you purchased, or the mailing packaging.

7- It’s simple. If the packaging is fake. So are the drugs.

Leave a Comment

Consumers Continue to Buy Risky Drugs Online

February 4, 2008 at 4:10 pm · Filed under FDA, Internet drugs, fake drugs ·Tagged , , ,

FDA Says Consumers Continue to Buy Risky Drugs Online
Self-medication a concern; FDA-approved generics may be cheaper alternative

A yearlong U.S. Food and Drug Administration (FDA) investigation into drugs mailed to the United States from foreign countries suggests that consumers may be buying drugs online to avoid the need for a prescription from their physician. The FDA sampling of imported drugs also indicates that consumers continue to spend money unnecessarily on potentially risky drug products bought over the Internet.

The investigation found 88 percent of the 2,069 drug packages examined appeared to be prescription medicines available in the United States. Of the remaining products, some were dietary supplements, some were foreign products with labeling that was illegible or incomprehensible, and some were medications not available in the United States. More than half (53 percent) of the products sampled have FDA-approved generic versions, likely sold at lower costs, according to earlier studies that have shown generics in the United States to be generally cheaper than a comparable drug in Canada or Western Europe. In fact, approved generic versions of approximately half (47 percent) of the sampled products can be bought for $4 at several national chain pharmacies, a price often lower than the shipping costs for the same drugs purchased online.

“The data lead us to believe that many people are buying drugs online not to save money but to bypass the need for a prescription from their doctor since these Web sites typically do not require the purchaser to have a prescription,” said Randall Lutter, Ph.D., FDA’s deputy commissioner for policy. “In essence, they seem to be getting and using prescription drugs without a prescription, an intrinsically risky practice.”

These data are based on surveys conducted from September 2006 to August 2007 in international mail facilities and courier facilities across the country. At each city surveyed, a selection of parcels suspected by U.S. Customs and Border Protection of containing pharmaceuticals were stopped. FDA then recorded data on the contents of these parcels, before handling them in accordance with its usual procedures.

In general, a Web site can appear legitimate, but in fact be a front for an illegal operation. FDA urges consumers to beware of unregulated Internet drug sellers, because many of their products might not contain the correct ingredients and could contain toxic substances. Several drugs found in this survey require special monitoring by physicians or other health care professionals for potential adverse events and to ensure their effectiveness. These include antibiotics, antidepressants, the blood thinner warfarin, and levothyroxine (a thyroid replacement hormone).

For additional FDA resources regarding online sales of prescription drugs: http://www.fda.gov/buyonline/ 

Leave a Comment

FDA Helping Patients Avoid Counterfeit Drugs over the Internet (September 2007)

February 4, 2008 at 4:05 pm · Filed under FDA, fake drugs ·Tagged , ,

This story originally aired in September 2007 (http://www.mediamax.com/fdapsn/Hosted/FDA-SHOW72-SEG1.MPG).

FDA has previously warned about the risks of buying drugs and other medical products over the Internet. Products bought on the Internet could be fake, sub-potent, or not approved by the FDA. They could also be counterfeit.

In 2007 the FDA discovered two different web sites selling a counterfeit version of the weight-loss drug Xenical. In one case, it actually contained another drug, and other samples contained just starch and talc. And that is just one example of the risks people take if they buy drugs over the internet.

An article in a recent issue of “Family Practice Management” gives several tips that practitioners can give to patients to help avoid counterfeit products. One is to advise patients to use only U.S. sites that are licensed by a State board of pharmacy. Some of these sites display the VIPPS seal, which stands for Verified Internet Pharmacy Practice Site. The National Association of Boards of Pharmacy gives the seal to Internet pharmacies that meet State licensure and other criteria.

The article also suggests advising patients to carefully compare the appearance and packaging of the medicines they buy online with the same medicine they may have gotten in the past from a conventional pharmacy. If the Internet product does not match up exactly, the patient should not use it. The suspected counterfeiting should be reported to the drug manufacturer, and to the FDA through the Medwatch system.

The article lists some of the drugs that are most susceptible to counterfeiting and points outs that counterfeiters tend to favor expensive drugs that are sold in large volume, e.g., anti-cholesterol medications. The article notes that so-called “embarrassment drugs” are widely counterfeited i.e., drugs for conditions that patients may be reluctant to discuss with their doctors. This would include drug such as Viagra, Cialis and Propecia.

Leave a Comment