CERI’s Import Policy Recommendations

Based on the FDA’s assurance that the personal import policy is still in effect, CERI is making the following recommendations to our subscribers for ordering overseas drugs:

1. Read the import policy again carefully.

2. Don’t panic if your drugs are detained. Ordering overseas drugs is not illegal, and you cannot be prosecuted for importing them under the FDA personal importation policy even if you make a procedural mistake. Your worst cost will be the money you spent in ordering the drug and the time you invest in presenting your claim with the government.

3. Fight for your drugs. If you get a letter from U.S. Customs or the Department of Health and Human Services (FDA), reply to it immediately. Inform them that your drugs are for personal use and ask that your drugs be released for shipment to you immediately. You have only a limited time to make your claim (10 days). If the letter is postmarked after the expiration date (it has happened), don’t give up. Write anyway and document their responsibility for the delay. Be sure to mention any serious medical consequences that might ensue as a result of you not receiving the drug promptly. Make them think twice about making an arbitrary decision that could generate negative publicity. Follow up each communication promptly, and make your case as strongly as you can. Ask for phone numbers when you write, call to verify their receipt of your letters, and take notes of each conversation (the date, time, name of person to whom you speak, and what they said in answer to your questions).

4. Stay in touch with CERI. Send us photocopies of all letters, postmarks, and correspondence related to your use of the personal importation policy. Tell us your story. If you would be willing to be interviewed by the media about the FDA detentions and seizures, please let us know. We are putting out press releases about FDA activities and would like to be able to refer the media to the people being directly affected by these policies.

5. When you order an overseas drug, send the company a letter to be returned with your shipment. Include your name, address and phone number, your doctor’s name, address and phone number, and any other interested persons (lawyer, guardian, family member, etc.). The FDA may want to have your order shipped directly to your doctor or guardian. The letter should also state the following: 1) that the drug is for personal use only, 2) that the amount is within the personal-use guideline (3 month’s supply), 3) that the drug is not approved in the United States, 4) that you were responsible for requesting the drug, 5) that the company shipping it to you did not engage in promotional activities related to the drug or you, 6) that your doctor will be supervising your use of the drug (provide a photocopy of the prescription if you have one), and 7) that the drug is for treating a life-threatening or debilitating condition (you may or may not want to detail your medical condition).

6. If you are ordering a drug that is available by prescription within the United States, you will have to make some kind of claim that the overseas drug is medically better than the US drug. A doctor’s prescription for the specific brand name you are ordering is probably essential.

7. The FDA regulations specify that the drug must be for a life-threatening or debilitating condition. If you are basically healthy, you might want to avoid the details of your medical reason for ordering the drug. If they insist, you can always argue that you are suffering from age-related mental decline (a debilitating illness) or from aging (a life-threatening illness). They may choose to disagree with your classification of your condition, but they won’t be able to prosecute you for lying. Everybody over 30 suffers from those conditions. They may also get so overwhelmed with the volume of traffic that they automatically pass shipments that appear to meet all the necessary conditions. We are very interested in hearing about the success or failure of such strategies.