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Q. What is the definition of a counterfeit medication?
A. U.S. law defines counterfeit drugs as those sold under a product name without proper authorization. Counterfeiting can apply to both brand name and generic products, where the identity of the source is deliberately and fraudulently mislabeled in a way that suggests that it is the authentic approved product. Counterfeit products may include products without the active ingredient, with an insufficient quantity of the active ingredient, with the wrong active ingredient, or with fake packaging.
Q. What risks are involved with taking counterfeit medications?
A. An individual who receives a counterfeit medication may be at risk for a number of dangerous health consequences. Patients may experience unexpected side effects, allergic reactions, or a worsening of their medical condition. A number of counterfeits do not contain any active ingredients, and instead contain inert substances, which do not provide the patient any treatment benefit. Counterfeit medications may also contain incorrect ingredients, improper dosages of the correct ingredients, or they may contain hazardous ingredients.
Q. What is the worldwide prevalence of counterfeit medications?
A. The extent of the problem of counterfeit drugs is unknown. Counterfeiting is difficult to detect, investigate, and quantify. So, it is hard to know or even estimate the true extent of the problem. What is known is that they occur worldwide and are more prevalent in developing countries. It is estimated that upwards of 10% of drugs worldwide are counterfeit, and in some countries more than 50% of the drug supply is made up of counterfeit drugs.
Q. What is the prevalence of counterfeit medications in the U.S.?
A. Counterfeiting occurs less frequently in the U.S. than in other countries due to the strict guidelines, regulations, and enforcement the FDA provides throughout the production and distribution chain. However, recently FDA has seen two highly publicized examples of counterfeit Lipitor and Procrit within the U.S. distribution system. The FDA continues to believe that the overall quality of drug products that consumers purchase from U.S. pharmacies remains high. The American public can be confident that these medications are safe and effective.
Q. Should consumers who currently purchase medications over the Internet or import medications from other countries be concerned about counterfeits?
A. Consumers can be confident in the quality, safety, and efficacy of medications purchased from a U.S. state licensed pharmacy. For those consumers who purchase medications over the Internet, websites that have the Verified Internet Pharmacy Practice Sites (VIPPS) Seal are licensed pharmacies where FDA-approved medications can be purchased. These sites are identified by the VIPPS hyperlink seal displayed on their Website. Unless medications have been purchased from a U.S. state licensed pharmacy website, the safety and efficacy of these medications cannot be guaranteed.
Q. What is FDA announcing today?
A. FDA is undertaking a major new initiative to more aggressively protect consumers from drugs that have been counterfeited. The new initiative includes creating an internal task force to explore the use of modern technologies and other measures that will make it more difficult for counterfeit drugs to get mixed up with – or deliberately substituted for – safe and effective drugs. FDA has already increased its enforcement efforts, more than quadrupling the number of counterfeit drug cases since 2000.
Q. Why is FDA taking these steps?
A. Although FDA does not believe that the number of counterfeits entering the U.S. drug supply has significantly escalated in recent years, the agency believes that it needs to be proactive to prevent the number of counterfeit drugs reaching consumers from increasing. Growth in counterfeiting may be spurred by the economic incentives provided by an increasing volume of high cost drugs, the development of technologies that make it easier to counterfeit drugs, and the ability to sell drugs directly to consumers without face-to-face contact through purchases over the Internet.
Q. How can pharmacists, physicians, and other healthcare professionals identify counterfeit medications?
A. Pharmacists, physicians, and other healthcare professionals should familiarize themselves with those drugs most likely to be counterfeited and how to identify these products. FDA will periodically place updated information regarding counterfeiting on its website. Healthcare professionals should suspect that a patient may have received a counterfeit drug when a patient has experienced an unexplained worsening of their medical condition or an unexpected side effect. Healthcare professionals who believe that a patient has received a counterfeit drug should contact the FDA immediately. In addition any irregularity in packaging or labeling of a drug should be reported to the FDA and the manufacturer immediately. Healthcare professionals can contact the FDA at http://www.fda.gov/medwatch or 1-800-FDA-1088.
Q. What can consumers do to protect themselves from counterfeit drugs?
A. Consumers can protect themselves from the risks associated with counterfeit drugs by purchasing all prescription and over-the-counter medications from U.S. state licensed pharmacies. Consumers must be vigilant when examining their personal medications, paying attention to the presence of altered or unsealed containers or changes in the packaging of the product. Differences in the physical appearance of the product, taste, and side effects experienced should alert the patient to contact their physician, pharmacist, or other healthcare professional who is providing treatment.
Q. What will the FDA do to educate consumers, pharmacists, and physicians about counterfeit drugs?
A. One purpose of the task force is to determine the most effective means of educating each of these groups about counterfeiting. FDA will ask outside organizations to work with the task force on ways to effectively address this issue.
Q. How will FDA work with government agencies to combat counterfeits?
A. The FDA is currently working with various government agencies, such as the Department of Homeland Security and the Department of Justice, to combat counterfeit drugs. The task force will work to gather information and develop an action plan that incorporates and coordinates the skills and strengths of each agency.
Q. What is FDA currently doing with US Customs on this issue?
A. FDA is working with the Bureau of Customs and Border Protection (BCBP) in conjunction with their upcoming "blitz" operations. These operations will take place this summer at International Mail Branches. BCBP scientists will work with FDA inspectors to target, examine, and test packages containing pharmaceuticals. This operation will enable BCBP to evaluate the type, volume, and quality of imported medications, along with providing reliable and up to date data to FDA.
Q. How will FDA work with the public and industry to combat counterfeits?
A. The FDA is currently working with pharmaceutical manufacturers, wholesalers, and retailers to identify and prevent counterfeit drugs. A successful plan will require the cooperation of manufacturers, wholesalers, and retailers to track drugs through the marketplace, identify counterfeit drugs, and notify the FDA of any potential counterfeit drugs. The task force plans to gather information from manufacturers, wholesalers, healthcare professionals, consumer groups, and other members of the public to help inform its decision making process.
Q. Are there any promising technologies that have the capability of preventing counterfeiting?
A. There are several technologies that may prove helpful, including radio frequency chips, taggants. For example, radio waves are used to automatically identify items, such as pharmaceutical products, by assigning individual serial numbers to each product. This technology may be capable of ensuring that drugs are not diverted or counterfeited by allowing wholesalers and pharmacists to determine the identity and dosage of individual products.
Q. Is expressing a concern for counterfeit drugs an excuse for cracking down on cheap drugs that Americans import from Canada?
A. No, the FDA is concerned about unsafe counterfeit drugs. Counterfeits are not equivalent in quality, safety, and efficacy to the authentic drug. Counterfeits may enter the U.S. distribution system from within the U.S. or from other countries, including Canada. The FDA is not attempting to single out any individual country in its efforts to protect Americans from counterfeit drugs.
Q. Will allowing reimports increase the amount of counterfeit drugs in the U.S.? If drugs can be manufactured overseas and sold in the U.S., why can't drugs be reimported?
A. Yes. The number of counterfeits in the U.S. is currently small as a result of the framework of federal-state oversight of the domestic drug distribution system. Currently, drugs entering the U.S. distribution system from other countries are FDA-approved, made in a facility that has been approved by FDA, and imported from the original manufacturer. Therefore, consumers can have high confidence that the medications they receive from their pharmacy are safe and effective. Recent proposals for reimportation would allow drugs from foreign sources other than the original manufacturer to enter the U.S. market. FDA has no authority to regulate these foreign entities nor to determine under what conditions drugs from other countries have been stored and handled. Even FDA-approved drugs sent to another country and then reimported may be contaminated or subpotent due to mishandling. Therefore, wholesalers, pharmacists, consumers, and FDA have no way of knowing if any drug reimported into the U.S. is truly the U.S.-approved product or has been inappropriately stored or handled.
Q. Will FDA be requesting new legislation to prevent counterfeiting from increasing?
A. There are clear opportunities to do a better job protecting drug products from counterfeiters using modern technologies. New approaches that were not possible when the Prescription Drug Marketing Act (PDMA) was implemented 15 yrs ago are available or on the horizon. The task force will be looking for the best solutions to the problems recently uncovered by our investigators and we may have more to say on this issue later. FDA does intend to work with Congress to stiffen penalties for those who counterfeit drug products.
Q. How do counterfeits relate to current bioterrorism issues?
A. Although counterfeit drugs and bioterrorism may potentially be related, FDA has no reason to believe that counterfeit drugs are being manufactured or introduced for any reason other than making a profit. The FDA knows of no current activity where use of counterfeit drugs is connected with terrorism. However, FDA is working with appropriate agencies within the Department of Health and Human Services and the Department of Homeland Security to ensure that if any such threat appears, it will be immediately identified and addressed.
Q. What were the circumstances of the recent FDA investigation of counterfeit Procrit?
A. Between January and February 2003 several people engaged in the sale of counterfeit Procrit and introduced the product into the wholesale distribution system. The counterfeit Procrit, discovered by investigators, consisted of a clear liquid that contained no medication for the treatment of anemia, cancer or HIV. The counterfeit Procrit contained only bacteria-tainted water thereby posing a risk of infection in already seriously weakened patients. The Untied States Attorney for the Southern District of Florida, filed charges in May 2003, against three people for trafficking and unlawfully distributing counterfeit prescription drugs.