Archive for Internet drugs

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

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Eli Lilly and Co. is gearing up to fight legislation that would allow Americans to import lower-priced prescription drugs

February 13, 2008 at 9:06 pm · Filed under Internet drugs, fake drugs ·Tagged ,

January 22, 2008
Lilly girds for drug import battle
Counterfeit fears mark U.S. debate over scripts’ cost

By John Russell
January 22, 2008

http://www.indystar.com/apps/pbcs.dll/article?AID=/20080122/BUSINESS/801220335

 Eli Lilly and Co. is gearing up to fight legislation that would allow Americans to import lower-priced prescription drugs from other countries, saying it would put consumers at huge risk of dangerous counterfeit medicines, which it says is growing to epidemic proportions.

The Indianapolis company and other U.S. drug makers won a similar battle last year when the Senate killed a drive that would have allowed consumers, pharmacists, drug wholesalers and distributors to import drugs from Canada, Japan, Australia and many European countries.
But what the drug industry sees as a threat to patient safety and its intellectual property, some consumer groups say is a needed way to provide lower-cost drugs to Americans, who pay the highest prices in the world for prescription medicines. Supporters say the bill adequately protects the public against counterfeit drugs.
The bill has yet to be set for a vote, and both sides say it could come up with little notice.
As the cost of prescription drugs rise and health-care costs loom as a top issue in this year’s presidential election, the issue of affordability and accessibility are sure to resonate in Washington and around the country.
The stakes are high for drug makers. Many other countries keep drug prices low through government controls. But Americans wind up paying the higher market price for drugs, meaning they often pay two-thirds more than Canadians, 80 percent more than Germans and 100 percent more than French residents pay for identical prescription drugs.
“The issue of importation is a big fear for the entire pharmaceutical industry,” said Robert Hazlett, a drug analyst for BMO Capital Markets in New York. “It’s tough to put a dollar figure on what it could cost drug companies if importation legislation passed.”
Lilly, for its part, say price controls stifle innovation and reduce competition. Along with other drug makers, Lilly counts on higher prices paid by Americans to fund expensive research for new drugs.
The real issue, Lilly said, is the sharply rising epidemic of counterfeit drugs — fake, unregulated, illegal drugs made in Third World countries. Since January 2006, customs officials around the world have seized more than 3 million counterfeit or suspected counterfeit tablets, in more than 1,000 separate actions, the company said.
Lilly said counterfeit versions of six of its branded drugs have been seized around the world, including antipsychotic Zyprexa, erectile-dysfunction drug Cialis and antidepressant Cymbalta.

Wide span of fakes

According to the World Health Organization, just about every type of drug has been counterfeited, from antihistamines and erectile dysfunction drugs to medicines designed to treat serious diseases, such as cancer, malaria and AIDS.
The organization calls counterfeiting “an enormous public health challenge.” A woman in Argentina who had mild anemia died of liver failure in 2004 after taking a highly toxic counterfeit. A woman from Canada was fatally poisoned by fake drugs she received over the Internet laced with deadly metals.
Many of the drugs, the industry says, are made by organized criminals in unsanitary conditions that would never pass FDA approval. They can make huge profits without overhead costs, quality control or regulatory enforcement.
“They might run a batch of Viagra, then a batch of Cialis, then a batch of Lipitor, and then they might do some narcotics,” Michael J. Muller, director of Lilly’s global anti-counterfeiting operations. “These guys are after money, a quick buck.”
Lilly says the volume of global counterfeiting comes to about $30 billion, which would represent about 5 percent of global sales. The company expects the figure to double by 2010.
Only a tiny fraction of counterfeit drugs enter the U.S. market. But Lilly and other drug makers say they could widen to dangerous levels if Congress relaxes the federal ban on imported drugs.

High costs

Last year, Lilly sold its case by taking out newspaper advertisements, enlisting help from the powerful industry trade groups, and telling its story to more than 100 congressional staffers.
In the meantime, the company said it spends more than $1 million a day to fight drug counterfeiting around the world, beefing up its security, legal, anti-counterfeiting, quality control and other functions.
But advocates of drug importation say keeping the ban in place is more of a protection for the industry than a safety measure for consumers. They say U.S. regulators can protect consumer safety.
“The counterfeit argument is absolutely a red herring,” said Barry Piatt, press secretary to U.S. Sen. Byron L. Dorgan, D-N.D., who was the chief sponsor of last year’s measure. “What the drug companies don’t tell you is they themselves import medicines into this country from their plants overseas.”
Dorgan’s bill, he said, includes provisions that would allow the Food and Drug Administration to inspect warehouses of foreign exporters and domestic importers.

Consumer support

Many consumer groups support a bill to allow imports. Union Senior Action, an Indianapolis advocacy group that represents about 13,000 senior Hoosiers, said it has helped dozens of people travel to Windsor, Canada, to buy drugs.
“When you’re taking several medications a day, the savings can be substantial,” said Paul Severance, the group’s founder and retired executive director.
The AARP, the nation’s largest advocacy group for seniors, has steadily supported relaxing the ban on drug imports. The group points out that drug prices are rising at nearly twice the annual rate of inflation, taking a toll on consumers, private sector health insurance and state budgets.
“If Eli Lilly can have manufacturing facilities all over the world, and bring their product into the U.S. safely to sell here, why is it that similar safety provisions can’t be put in place to allow individuals to purchase drugs from abroad,” said Anna Howard, a senior legislative representative with the AARP.
But the Bush administration has said the worldwide drug market is so vast, it can’t guarantee the safety of imported medicines.
Lilly said that it offers several programs for needy consumers, including uninsured Americans, to obtain drugs. Medicare Part D, a federal program that subsidizes the cost of prescription drugs, has helped millions of seniors obtain cheaper drugs, the company said.

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Fake drug web sites

February 7, 2008 at 10:57 am · Filed under Internet drugs, fake drugs ·Tagged ,

It’s somewhat an irony that a blog dedicated to eliminating fake drugs is SPAM’d with solicitations for fake drugs.

So we’re going to begin listing sites that are used to solicit and sell fake drugs:

bestsslscripts.com

freewebtown.com

rxsslscripts.com

If you have a website that uses SPAM to solicit prescription drug sales, or you suspect a fake drug web site, comment on the blog.

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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. 

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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.

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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/ 

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