Dear Neighbors,

There has been quite a lot of discussion about buying medicines over the Internet in the news lately. I feel this is an important issue for many of my constituents. The following is information I've learned from various sources. I strongly urge you to review these sources, read their information completely, and come to your own determination before deciding whether to go online to buy prescriptions and from which sites you may choose to purchase them.

Background:

To gain approval to sell a drug in the U.S. market, a drug manufacturer must demonstrate that the drug is safe and effective, and that the manufacturing methods and controls that used in the specific facility where it will be manufactured meet FDA standards. Drugs are subject to other standards relating to purity, labeling, manufacturing, and packaging. Failure to meet these standards could result in a drug being considered illegal for sale in the U.S. FDA-approved drugs manufactured in foreign countries, including those sold over the Internet, are subject to the same requirements as domestic drugs. Drugs must also have an uninterrupted chain of custody between manufacture and sale to prevent the introduction of counterfeit or expired drugs.

Some Statements from FDA Testimony to the U.S. House Committee on Government Reform: http://www.fda.gov/ola/2004/internetdrugs0318.html

• FDA is aware that many reputable Internet pharmacies provide consumers seeking prescription drugs with a measure of safety, privacy and convenience.
• Some also sell drugs for less than traditional "brick-and-mortar" pharmacies. A number of online drug websites, however, present risks to purchasers ...
• FDA remains concerned about consumers ... there is not sufficient information or means to assure that these products are as safe and effective as products sold within the U.S.
• Consumers may have difficulty identifying which sites sell legitimate products.
• Risks include potential side effects from inappropriately prescribed medications, dangerous drug interactions or drug contamination ... counterfeit copies that contain inert ingredients, outdated drugs, or dangerous sub-potent or super-potent products that were improperly manufactured.
• While Internet sites operated by legitimate, properly licensed pharmacies provide genuine benefits to consumers, sites that are unlicensed or otherwise engaged in the illegal dispensing of prescription drugs pose a serious potential threat to the health and safety of American citizens.

U.S. General Accounting Office (GAO) Report, Internet Pharmacies: Some Pose Safety Risks for Consumers and Are Unreliable in Their Business Practices: http://www.gao.gov/new.items/d04820.pdf

• FDA's comments to this report include the caution that the report "repeatedly states that the Internet sites ‘purported’ or ‘appeared’ to be from Canada, the U.S., or other foreign countries. The study does not demonstrate with any certainty, particularly for the U.S. or Canadian websites, that the products were sent from or manufactured for use in those countries ..."
• FDA's comments also included the caution that while many of the samples were chemically equivalent to FDA-approved drugs, there is no guarantee that the samples were identical. The foreign drug may contain different inactive ingredients to which some may be allergic. There is also no guarantee that the drugs are bioequivalent or therapeutically equivalent.
• GAO obtained 68 samples of 11 different drugs from pharmacy web sites purported to be based in the U.S., Canada, and "other foreign" countries including Argentina, Costa Rica, Fiji, India, Mexico, Pakistan, Philippines, Spain, Thailand and Turkey.
• Most problems found with the handling, FDA-approval status and authenticity of the drugs came from samples outside the U.S. and Canada. Some Internet pharmacies were not reliable in their business practices.
• Five U.S. and all 18 Canadian pharmacies required the patient to provide a prescription. The remaining 24 U.S. and all 21 "other foreign" Internet pharmacies issued prescriptions based on their own questionnaire or had no prescription requirements.
• 41 of 47 samples received from U.S. and Canadian Internet pharmacies included warning information. 16 of the 18 samples from Canadian Internet pharmacies had unapproved labeling and packaging. One moisture sensitive drug from a U.S. Internet pharmacy was inappropriately removed from the sealed manufacturer's container and dispensed in a regular pharmacy bottle. Thirty-five samples from Canadian Internet pharmacies dispensed drugs not approved for the U.S. market.
• About 21% (14 of 68) of the Internet pharmacies were under investigation by regulatory agencies for allegations of selling controlled substances without a prescription; selling adulterated, misbranded or counterfeit drugs; selling prescription drugs without a doctor-patient relationship; smuggling and mail fraud. Nine were U.S. pharmacies, 1 was Canadian, four were "other foreign" pharmacies.

Tips for Buying Medicines and Medical Products Online and Other Useful Sources of Information:

Go to http://www.fda.gov/oc/buyonline for more information, such as Frequently Asked Questions, Consumer Safety Guide, and other tips for consumers.

The National Association of Boards of Pharmacy's (NABP) Verified Internet Pharmacy Practice Sites (VIPPS) program at http://www.nabp.net/vipps/intro.asp has information on the criteria used to evaluate pharmacies, lists of verified Internet pharmacies, and other useful information.

The State of Alaska's Board of Pharmacy website is at http://www.dced.state.ak.us/occ/ppha.htm.

I hope this information has been helpful to you.

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