http://www.fda.gov/fdac/features/2004/204_illegal.html

FDA Crackdown on Illegal Products

During 2003, the Food and Drug Administration took significant strides to address the growing threat of illegal drugs and false health claims related to dietary supplements. "Our major priority is to continue fostering the legitimate manufacture, sale and use of FDA-regulated products while maintaining a zero-tolerance approach to illegal practices," says John Taylor, the FDA's associate commissioner for regulatory affairs. "We're working to allocate resources in a way that maximizes our impact on public health."

Here are some examples of recent actions by the agency:

Warnings on imported drugs: The FDA has long been concerned about the dangers faced by consumers who buy medications outside of the United States. During the fall of 2003, the FDA issued warnings and filed complaints against Rx Depot of Lowell, Ark., and CanaRx Services of Detroit to stop them from importing drugs from Canada. The FDA considers these operations illegal and dangerous.

CanaRx made misleading assurances to consumers about the safety of its drugs. An FDA investigation of CanaRx showed that the firm does not consistently use shipping practices necessary to ensure its drugs are safe and effective. For example, the FDA collected evidence demonstrating that CanaRx shipped insulin that hadn't been properly stored. In another case, an FDA investigator bought a prescription antidepressant drug called Serzone (nefazodone) from Rx Depot. The prescription called for 60 pills, with instructions for one pill to be taken twice a day for 30 days. But the investigator received 99 pills of APO-Nefazodone, an unapproved, foreign-manufactured version of Serzone's active ingredient.

Illegal claims on dietary supplements: In November 2003, the FDA announced that NBTY Inc. of Bohemia, N.Y., had destroyed about $3 million worth of Royal Tongan Limu, a dietary supplement that had been promoted to treat cancer, arthritis, attention deficit disorder, and other conditions. The supplements were distributed by Dynamic Essentials, an NBTY subsidiary in Lake Mary, Fla. After an FDA investigation of the firm's New York and Florida locations, Dynamic Essentials decided to cease operations and destroy the product.

In October 2003, the FDA announced it had entered a consent decree of permanent injunction against several corporations, including Hi-Tech Pharmaceuticals, National Urological Group, National Institute for Clinical Weight Loss, American Weight Loss Clinic, and United Metabolic Research Center to prevent the sale of unapproved and misbranded products. The defendants repeatedly sold dietary supplements that made false claims about treating obesity and erectile dysfunction.

"Getting rid of these products underscores the message from FDA to those who would mislead consumers about their health," says FDA Commissioner Mark B. McClellan, M.D., Ph.D. "We will not tolerate companies that raise false hopes for preventing and treating illnesses, when there are more scientifically proven steps than ever before that consumers can take to improve their health."

Drugs seized from repackager: In September 2003, the FDA seized all drug products labeled in a foreign language and/or repacked by Alliance Wholesale Distributors and Local Repack in Richton, Ill. The FDA's inspections of Local Repack revealed that the company failed to report customer complaints to the FDA and failed to maintain complete records, along with numerous other deficiencies. The FDA determined that many of the products at Local Repack were of unknown origin, and their storage and handling conditions were unverifiable.

Import Blitz Reveals Safety Concerns

Mail shipments of foreign drugs to U.S. consumers often contain dangerous, unapproved or counterfeit drugs, according to two "blitz exams" conducted by the Food and Drug Administration and U.S. Customs and Border Protection (CBP).

Import blitz exams are targeted examinations of parcels at a select number of mail facilities over a specific time. The exams help the FDA understand trends in the illegal importation of unsafe drugs, target future shipments and sources of such drugs, and seek partnerships with other federal, state and international partners to combat the problem.

Generally, due to the huge volume of parcels entering the United States, the FDA and CBP don't have sufficient resources to perform comprehensive examinations of all mailed packages. Through review of historical data and experience, FDA and CBP personnel are able to identify parcels likely to contain imported drug products.

One round of blitz exams was conducted last summer in mail facilities in Miami, New York City, San Francisco, and Carson, Calif. Of the 1,153 imported drug parcels examined, 88 percent contained unapproved drugs from many countries.

Here are some examples:

* Drugs different from those approved by the FDA: Roaccutane, an unapproved version of the acne drug Accutane (isotretinoin), was imported into the United States from Thailand. Taro-warfarin, an unapproved version of warfarin, was imported from Canada. Warfarin is used to prevent blood clots.
* Drugs requiring careful dosing: Inspectors discovered unapproved versions of Dilantin (phenytoin) from the Philippines, unapproved versions of Synthroid (levothyroxine) from Canada, and unapproved versions of Glucophage (metformin) from Canada and the Philippines.
* Drugs with inadequate labeling: Most of the drugs came without adequate labeling or instructions for proper and safe use. Some of the drug labeling was not in English.
* Drugs inappropriately packaged: In some cases, the drugs were in baggies, tissue paper or envelopes. Some drugs arrived crushed or broken.
* Drugs withdrawn from the market: Buscapina, an unapproved drug that came from Mexico, appeared to be the pain and fever drug dipyrone. The FDA removed dipyrone from the market in 1977 because of potentially fatal side effects.
* Animal drugs not approved for human use: One drug called clenbuterol is banned by the International Olympic Committee as a performance-enhancing drug. Clenbuterol is approved to treat airway diseases in horses, but is not approved for humans.
* Drugs with potential for dangerous interactions: Unapproved versions of Viagra (sildenafil) were shipped from the United Kingdom, India, the Philippines and Japan. Unapproved versions of Zocor (simvastatin) came from Canada. These drugs can cause significant interactions with other drugs.
* Drugs requiring screening and monitoring: Unapproved versions of the cholesterol drug Lipitor (atorvastatin) came from Ireland, Thailand, Japan, the Philippines, Canada, Argentina, New Zealand, England, and Brazil. Unapproved versions of Pravachol (pravastatin), another cholesterol drug, came from Canada. For both drugs, screening and monitoring of patients' liver function are needed.
* Controlled substances: More than 25 different imported controlled substances were referred to the Drug Enforcement Administration.

A second import blitz exam, done in November 2003 at the Buffalo, Chicago, Dallas, and Seattle postal facilities and at the Memphis and Cincinnati courier hubs, found 1,728 unapproved drugs, including so-called "foreign versions" of FDA-approved drugs. The blitz also found recalled drugs, drugs requiring close physician monitoring, and drugs containing addictive controlled substances.

Things you should know about purchasing
medicines from outside the United States.

If you buy foreign medicine from an Internet site, from a storefront business that offers to order medicine for you, or during visits outside the United States, you are taking a risk. The U.S. Food and Drug Administration (FDA) cannot guarantee the safety of these medicines.

QUALITY ASSURANCE CONCERNS. Medicines that have not been approved for sale in the United States may not have been manufactured under quality assurance procedures designed to produce a safe and effective product.

COUNTERFEIT POTENTIAL. Some imported medicines - even those that bear the name of a U.S.-approved product - may, in fact, be counterfeit versions that are unsafe or even completely ineffective.

PRESENCE OF UNTESTED SUBSTANCES. Some imported medicines and their ingredients, although legal in foreign countries, may not have been evaluated for safety and effectiveness in the United States. These products may be addictive or contain other dangerous substances.

RISKS OF UNSUPERVISED USE. Some medicines, whether imported or not, are unsafe when taken without adequate medical supervision. You may need a medical evaluation to ensure that the medicine is appropriate for you and your condition. Or, you may require medical checkups to make sure that you are taking the medicine properly, it is working for you, and that you are not having unexpected or life-threatening side effects.

LABELING AND LANGUAGE ISSUES. The medicine’s label, including instructions for use and possible side effects, may be in a language you do not understand and may make medical claims or suggest specific uses that have not been adequately evaluated for safety and effectiveness.

LACK OF INFORMATION. An imported medicine may lack information that would permit you to be promptly and correctly treated for a dangerous side effect caused by the medicine.

FDA Takes Action Against Company for Illegal Importation of Unapproved, Potentially Unsafe Drugs

The U.S. Attorney's Office, Southern District of New York, has on behalf of the Food and Drug Administration (FDA), filed a civil complaint against Canada Care Drugs, Inc. (Canada Care), Claire Ruggiero, and Christine Ruggiero for the illegal importation of prescription drugs into the U.S.

Canada Care was previously affiliated with Rx Depot, Inc., a company that was engaged in the illegal importation of prescription drugs until November 6, 2003, when the United States District Court for the Northern District of Oklahoma entered an order of preliminary injunction against the company and its affiliates to stop their illegal activity.

"By continuing to illegally import unapproved drugs, Canada Care is putting at risk the health of patients who are expecting to improve their health," said Dr. Lester M. Crawford, Acting FDA Commissioner.

According to the complaint filed in the Southern District of New York on Monday, following the preliminary injunction order against Rx Depot and its affiliates, which was made permanent with the entering of a consent decree on August 20, 2004, Canada Care severed its relationship with Rx Depot, but continued illegal activity in violation of the Food, Drug and Cosmetic Act (FDCA).

As is alleged in the complaint, FDA's investigation of Canada Care's illegal importation operations has revealed several products that pose a risk to the public health. In February and August 2004, FDA made two undercover purchases of the FDA-approved drugs Sporanox and Neurontin through Canada Care.

Instead of Neurontin, FDA received unapproved drugs called APO-Gabapentin and Novo-Gabapentin. The unapproved drugs purchased through the defendants pose a public health threat because, as alleged in the complaint, FDA cannot assure the safety and efficacy of unapproved drugs. Because unapproved drugs are not subject to the FDA's oversight, the FDA has no knowledge how unapproved drugs are made, what patient information is included with the drug, or what the side effects of the drugs are, and as a result they are more likely to be contaminated, counterfeit, inherently ineffective, or contain different amounts of the active ingredients from similar drugs that have been reviewed and approved by the FDA.

In addition, as alleged in the complaint, the manner in which the Sporanox shipment was sent by the foreign pharmacy posed a potentially serious health threat to the patients who received it. Patients should take it in treatment "pulses" of one week, and then wait three weeks before resuming another pulse treatment. Between treatments, patients should consult their doctors to determine whether the treatment should be terminated either because it is no longer necessary or because they are experiencing liver or heart side effects. Because the foreign pharmacy sent three packages of Sporanox at one time, patients receiving the drugs could have taken all 84 tablets without consulting their doctor in between "pulse" treatments - an action that could have exposed them to serious and even fatal side effects.

The complaint was filed in the United States District Court in the Southern District of New York and seeks to enjoin Canada Care from directly or indirectly importing or causing the importation of U.S.-manufactured and unapproved, foreign-manufactured prescription drugs into the U.S. in violation of the FDCA. The government will also seek preliminary injunctive relief and monetary relief in the form of restitution, disgorgement, or both.

FDA Warns Consumers About Counterfeit Drugs Purchased in Mexico

The Food and Drug Administration (FDA) is warning the public about counterfeit versions of the drugs Zocor (simvastatin) and carisoprodol that were recently imported from Mexico by individual Americans. Tests indicate that the counterfeit Zocor did not contain any active ingredient and that the counterfeit carisoprodol differed in potency when compared to the authentic product. Carisoprodol is a drug used in the treatment of painful musculoskeletal conditions and Zocor is a cholesterol lowering drug. The counterfeit versions were reportedly purchased at Mexican border town pharmacies and sold under the names Zocor, 40/mg, (lot number K9784, expiration date November 2004 and lot K9901, exp. date December 2006), and Carisoprodol, 350/mg, (lot number 68348A). Patients who rely on these counterfeit versions of the drugs could develop serious health risks (with the counterfeit Zocor) or have insufficient pain relief (with the counterfeit carisoprodol).

FDA has repeatedly expressed its concern about the purchase by Americans of drugs from foreign countries. As demonstrated by this incident, purchasers cannot assume that the products meet the quality, efficacy, and safety standards of FDA authorized products or that FDA is assuring the quality, safety, and efficacy of products purchased from outside the United States.

Medications purchased within the US system for prescription drugs have undergone rigorous testing and review to verify their identity, potency, and purity and to ensure that they are safe and effective for their intended use. In addition, there are safeguards to help maintain the integrity of the products while in shipment to pharmacies and prior to dispending to patients.

Anyone who may have recently purchased the above described versions of Zocor 40/mg and Carisoprodol 350/mg from Mexican pharmacies should consult with their physician as well as notify their local FDA field office.

FDA is investigating this matter and working with the Mexican authorities to ensure that further sale and importation of these products is halted.
----------------------------


Still hate the FDA?

Think again. Despite claims that corruption is rampant and that the FDA is in the pocket of drug companies, claims to the opposite can be made.

That is not to say that there are not instances of inpropriety, but overall it is not on a scale massive enough, nor bad enough to ditch the FDA or its drug regulation.

If it is an option...choosing between regulated drugs for a higher price or unregulated and potentially dangerous (but cheaper) drugs, I will always choose the former as opposed to the latter.

Its your health.

FDA Test Results of Prescription Drugs from Bogus Canadian Website Show All Products Are Fake and Substandard

A Food and Drug Administration (FDA) analysis of three commonly prescribed drugs purchased from a Web site advertised as Canadian showed that so-called "Canadian Generics" bought from the Web site were fake, substandard and potentially dangerous. One was a controlled substance. In light of these findings, FDA reiterates its strong concerns about purchasing prescription drugs online from unknown sources.

FDA investigators recently purchased three commonly prescribed drugs from a Web site advertising "Canadian Generics," which had been sending "spam" emails promoting its products. The products purchased were so-called "generic" versions of Viagra, Lipitor, and Ambien. None of the three products has a U.S.-approved generic version, and so all three drugs were unapproved.

"The test results of our analyses offer proof positive that buying prescription drugs online from unknown foreign sources can be a risky business. As was the case here, even where a website looks legitimate, FDA has clear evidence that the Web site is dispensing misbranded drugs that are not the same quality as those approved by the FDA for sale in the United States. Consumers who believe they are getting equivalent products from reputable sources are being misled and putting their health at risk," said FDA Acting Commissioner Dr. Lester M. Crawford. "This firm shipped drugs that were the wrong strength, including some that were substantially super-potent and that pose real health risks as a result, drugs that didn't dissolve properly, drugs that contained contaminants, and drugs that should not have been given because of potentially dangerous drug interactions."

Ambien, a controlled substance (schedule IV), is approved for the short-term treatment of insomnia in the U.S. The product FDA obtained online contained too much active ingredient, including one tablet that was nearly double the labeled potency. Taking "superpotent" Ambien puts patients at risk for central nervous system depression, especially in elderly or debilitated patients.

The so-called "generic" Lipitor FDA purchased was subpotent and failed standard dissolution tests, providing on average only 57 percent of the active ingredient claimed on the label. It also failed FDA's purity testing. Clinically, subpotent product could present a long-term risk for the various complications of high cholesterol, such as heart disease. In addition, the so-called "generic" Lipitor product was furnished to FDA's online purchaser, even though the purchaser said that he was taking the antibiotic Erythromycin. Lipitor's label warns against taking Lipitor and Erythromycin at the same time.

Viagra is sold in the U.S. to treat impotence. The so-called "generic" version of this product also contained too little of the active ingredient, failed the dissolution test, and had an unacceptable level of impurities. Although subpotent "generic" Viagra may not place patients at additional risk, the purchaser informed the firm in its on-line questionnaire that he was taking Erythromycin. Use of Viagra in patients taking Erythromycin is contraindicated.

FDA continues to advise patients and consumers that they must use great care when purchasing prescription drugs online. Our evidence indicates that although a Web site may appear to be hosted by a reputable source and may look similar to other retail pharmacy Web sites, many of these sites in fact operate from outside the United States and are providing unapproved drugs from unreliable sources. The National Association of Boards of Pharmacy (NABP) has established a program called VIPPS designed to certify Web sites that meet industry standards. The Agency believes that consumers should look for participation in this type of certification program as one method to help minimize the risks of getting bad quality drugs from disreputable sources.

Are you by any chance a representative for a major pharmecutical company?

We've argued this in the past, but here is the condensed counter-arugment anyway:

If you're terminally ill, or are in so much pain that life is unbearable, you may be willing to take a bigger risk in order to better your condition.

IIRC, I think we did agree on giving people a choice of drugs. Correct me if I'm wrong.

Yes we did agree Nick. I was presenting this mainly as a display of why the FDA is a good thing, to help to counterract all of the negative publicity it has been recieving. I do agree that there is, of course, probably some corruption on some levels, but I disagree that the entire agency is a lap dog for pharmaceutical companies.

I wanted to present this to show its effectiveness in combating counterfeit, illegal, and unsafe medications.