Illegal to buy meds outside the US?

[vegaslocal39]

I am lucky enough to have good insurance (knock on wood), but am always trying to plan for those "what if's" in life.  I take Atripla.  What if I did not have insurance?  Could I go to another country (prescription in hand) and buy enough Atripla for my own use here in the US?

The FDA web site warns against bringing in UNAPPROVED drugs to the US.  But what about FDA approved drugs that the traveler has a valid prescription for?  Is this illegal?

I was reading somewhere that a 1-YEAR supply of Atripla is available in developing countries for about the same price as we pay in the US for a 1-MONTH supply.  Let's assume for a moment that we can be sure that the pharmacy and the drugs purchased would be legitimate.  It might actually be cheaper to fly to Africa or India to buy Atripla, than it would be to stay home and buy it here in the US.

Is this possible?

[LordBerners]

One can only assume that bringing medications in that have not been controlled by the cartell would be illegal, Vegas, but it might still be worth it.  I think if you were searched by customs they would only confiscate the drugs, not jail you.

I would like to suggest Thailand as a good place to visit to buy cheap drugs - flights are probably a little cheaper than Africa or India from the US, plus it is a fairly developed country.

[vegaslocal39]

"One can only assume that bringing medications in that have not been controlled by the cartell would be illegal, Vegas, but it might still be worth it.  I think if you were searched by customs they would only confiscate the drugs, not jail you."

I'm not sure what this means.  I'm guessing an attempt at humor that just went over my head.  I can be pretty dense I guess.

My question is about bringing in medications for personal use that are approved by the US FDA, and that one is holding a valid prescription for.  I don't think that there is anything illegal about having meds in your posession that are prescribed for your use.  My question is, is it legal for a US citizen to purchase meds abroad and transport them home with them, as long as the meds are approved for use by the FDA and the person has a valid prescription from their doctor?

I'm really just curious more than anything.

[Assurbanipal]

If you google "drug reimportation" you'll find a ton of info.  Here's the official "travelers alert" from the FDA.  The general FDA website is

http://www.fda.gov/importeddrugs/


____________________________________________________________________

Importation of Prescription Medicines/Drugs
Traveler Alert
The U.S. Customs Service enforces Federal laws and regulations, including those of the Drug Enforcement Administration (DEA) and the Food and Drug Administration (FDA).

The United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. sections 331(d), and 355(a)), which is administered by FDA, prohibits the interstate shipment (which includes importation) of unapproved new drugs. Unapproved new drugs are any drugs, including foreign-made versions of U.S. approved drugs, that have not received FDA approval to demonstrate they meet the federal requirements for safety and effectiveness. It is the importer's obligation to demonstrate to FDA that any drugs offered for importation have been approved by FDA.

FDA has developed guidance entitled "Coverage of Personal Importations" which sets forth that agency's enforcement priorities with respect to the personal importation of unapproved new drugs by individuals for their personal use. The guidance identifies circumstances in which FDA may consider exercising enforcement discretion and refrain from taking legal action against illegally imported drugs. Those circumstances are as follows:

"1) the intended use [of the drug] is unapproved and for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means;

2) there is no known commercialization or promotion to persons residing in the U.S. by those involved in the distribution of the product at issue;

3) the product is considered not to represent an unreasonable risk;

and

4) the individual seeking to import the product affirms in writing that it is for the patient's own use (generally not more than a 3 month supply) and provides the name and address of the doctor licensed in the U.S. responsible for his or her treatment with the product, or provides evidence that the product is for the continuation of a treatment begun in a foreign country." (Emphasis added)

FDA's guidance is not, however, a license for individuals to import unapproved (and therefore illegal) drugs for personal use into the U.S. Even if all of the factors noted in the guidance are present, the drugs remain illegal and FDA may decide that such drugs should be refused entry or seized. The guidance represents FDA's current thinking regarding the issues of personal importation and is intended only to provide operating guidance for FDA personnel. The guidance does not create any legally enforceable rights for the public; nor does it operate to bind FDA or the public.

 

To avoid travel delays and to prevent possible harm from taking unsafe or ineffective medications, residents and visitors upon arrival to or departure from the U.S. should keep in mind the following precautions:

Do not assume that medications which are legal in foreign countries are also approved for use in the United States. These products may be illegal and may include addictive and dangerous substances;
 

Be aware that the labeled uses (conditions for which the product is represented to be effective) for a product purchased outside the U.S. may not be approved in the United States;
 

It can be dangerous to take some medications without medical supervision. The reason why some medications are limited to prescription use in the United States is that either they are unsafe without medical supervision or a medical diagnosis is required to ensure that the medication is appropriate for your condition;
 

Avoid purchasing any drug products that are not approved for sale in the U.S. (including foreign-manufactured versions of U.S. approved drugs). FDA cannot assure that these products conform to the manufacturing and quality assurance procedures mandated by U.S. laws and regulations and, therefore, these products may be unsafe. In addition, such products are illegal in the U.S. and, therefore, may be subject to entry refusal;
 

Some medications which may appear to be U.S. approved drug products may in fact be counterfeit versions of such products. (The term "counterfeit drug" is defined as "a drug which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device, or any likeness thereof, of a drug manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such drug and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other drug manufacturer, processor, packer, or distributor." See 21 U.S.C. 321(g)(2));
 

In the event you develop complications from using a medication which require medical attention, your treatment could be delayed or made more difficult unless there is sufficient information available about the product, such as the generic name of the product, dosage form and strength, and how often you need to take the product.
 

Possession of certain medications without a prescription from a physician licensed in the United States may violate Federal, State, and/or local laws;
 

It is important to have medications in the originally-dispensed container;
 

FDA's personal importation guidance provides that when bringing unapproved drugs into the U.S. for use in treating serious or life threatening illnesses, such products should be used under the care and supervision of a U.S. licensed physician. It is advisable to make available for examination by U.S. Customs Inspectors or other appropriate government authorities appropriate documentation of such monitoring;
 

It is against the law not to properly declare imported medications to U.S. Customs.
 

When the type of drug, the quantity, or the combination of various drugs arouse suspicions, U.S. Customs Inspectors will ordinarily contact the nearest FDA or DEA office for advice and will then make a final determination about whether to release or detain the article. (See 19 U.S.C. 1499).
In addition to federal requirements, individual States may have additional requirements covering prescription (Rx) or controlled medications. Travelers should check with State authorities, where they reside or are traveling, to verify that a particular prescription does in fact comply with State regulations. In many areas, the local police department and pharmacies can provide additional information.

 

For more detailed information on FDA's personal importation guidance, contact your local FDA office, or check out FDA's Internet website at:

http://www.fda.gov/ora/compliance_ref/rpm_new2/ch9pers.html

[vegaslocal39]

Interesting, but I had already read that on the FDA web site.  All of that information is in relation to UNAPPROVED drugs.  I am referring to FDA APPROVED drugs, purchased abroad, with a valid prescription, for personal use.

Let me know if I missed something in there that discussed FDA APPROVED drugs.

[darwin]

The way I read it:  It is legal to import drugs from foreign countries if 1) you have a prescription and 2) the drugs were manufactured in the United States (or, at least, manufactured by a company that is approved by the FDA).

This is really interesting - I have a 6 month window of no insurance coming up next year, and this looks very promising.

I wonder if the Atripla in Thailand or India is by Gilead/Bristol-Myers.  If so, I think its legal to bring to the states.

Now - Should you declare it with customs?  At first glance, it seems like it would be okay?

[vegaslocal39]

That's what I'm thinking Darwin, but I must be wrong.  I mean, you'd think this would be done often.  Why pay $1200-$1400 per month for Atripla here, when I could get it abroad for so much less, even when factoring in the trip.

[Ann]

Dunno, considering all the "intellectual copyright" crap that has been going on between said countries and said pharma companies and the support the latter has from the US government, I'd expect a hard time.

Just sayin....

[darwin]

Ack... they are so evil:

From: http://www.cbp.gov/xp/cgov/newsroom/alerts/foreign_medication.xml

"The Federal Food, Drug, and Cosmetic Act (FFDCA) prohibits persons from importing into the United States any prescription drug that has not been approved for sale by the United States Food and Drug Administration (FDA), or which is adulterated or misbranded. Moreover, in those instances where a United States manufacturer makes an FDA-approved prescription drug and sends it abroad, the FFDCA also prohibits any person other than the original manufacturer from importing the drug back into the United States. Thus, in virtually all instances, individual citizens are prohibited from importing prescription drugs into the United States."

[Assurbanipal]

Interesting, but I had already read that on the FDA web site.  All of that information is in relation to UNAPPROVED drugs.  I am referring to FDA APPROVED drugs, purchased abroad, with a valid prescription, for personal use.

Let me know if I missed something in there that discussed FDA APPROVED drugs.

Depends on what you meant by FDA APPROVED drugs. The FDA definition above is a very technical one under which even a foreign manufactured version of an otherwise approved drug is defined as not FDA approved.  ("Avoid purchasing any drug products that are not approved for sale in the U.S. (including foreign-manufactured versions of U.S. approved drugs). ") Thus the only "FDA APPROVED" drugs are US manufactured US drugs that have been exported and that you would be "reimporting". Those drugs may be less likely to meet the price constraints.   Foreign manufactured US drugs would fall under the non-approved policy for personal importation.

But if you read some of the other things that come up in google from the testimony (and the organized bus trips) it's clear that actual enforcement does not live up to the FDA's desires. Several of the sites refer to the three month supply rule. In fact the government task force that looked into it said the following in an official report to Congress

"The importation of certain unapproved prescription medication for personal use may be allowed in some circumstances if all of the following factors apply:
• If the intended use is for a serious condition for which effective treatment may not be available domestically;
• If the product is not considered to represent an unreasonable risk;
• If the individual seeking to import the drug affirms in writing that it is for the patient’s own use and provides the name and address of the U.S.-licensed doctor responsible for his or her treatment with the drug or provides evidence that the drug is for continuation of a treatment begun in a foreign country;
• If the product is for personal use and is a threemonth supply or less and not for resale. (Larger amounts would lend themselves to commercialization);
and
• If there is no known commercialization or promotion to U.S. residents by those involved in distribution of the product.
The majority of drugs coming into this country via personal importation today do not technically meet all of these factors. Nonetheless, given the high demand and limits on available resources it is difficult to effectively police this practice."

emphasis added
http://www.hhs.gov/importtaskforce/Report1220.pdf

The FDA is not likely to put out a road map on how to bend laws that they are sworn to uphold, so this is probably as close as you will get from an official source. For more info you might want to talk to one of the seniors groups that organizes the bus trips.

/edited for coherence, quote marks

[vegaslocal39]

Thanks all.  I knew you would dig up the answers.  Sounds like, technically no, it's not allowed.  But they'd probably look the other way for a 90-day supply of a legitimate med for which you carry a prescription.

[MitchMiller]

My guess is that if you revealed that you were bringing in generic versions of drugs under US patent, they would be summarily confiscated.   As I understand it, those that make the Canadian trek do not reveal they are carrying drugs when reentering the US.  In other words, they technically smuggle them into the US illegally.  However, the cost and political fallout to enforce the law are considered prohibitive. 

One exception: the Bush administration did expand US customs inspections to the tune of several extra millions of $$$, a few months before the expiration date for selecting a Medicare Part D drug plan.  Some figured out it would be cheaper to keep buying their drugs from abroad than to enroll in a plan.  The Bush administration's plan was to disrupt the flow of medications as a subtle encouragement to join Part D.  An outrage followed as many called their Congressmen to complain about the seizures and the Bush administration then revealed this secret operation and backed off a bit.  However, I do believe the rate of seizures has gone up considerably since Part D was initiated.

As I understand it the black market for personal importation of drugs is less than 5% of the total market, which is probably why Big Pharma hasn't exerted more pressure for the US gov't to spend more to better enforce FDA regulations.

[Roie]

That's what I'm thinking Darwin, but I must be wrong.  I mean, you'd think this would be done often.  Why pay $1200-$1400 per month for Atripla here, when I could get it abroad for so much less, even when factoring in the trip.

These meds do not  cost less "abroad" out of the US then what its costing in the USA. If you want American company meds they will cost the same or even more outside the US. If you want something that a Brazialian or Indian or Thai company had manufactured then perhaps they will cost less.

I live in Israel, and I am taking Truvada and Kaletra. These cost my med aid 7000 shekels a month which is $2027 on todays rate.

[MitchMiller]

Roie:  That may be true in Israel, but that's not typical.  It took me all of 30 seconds to dig up this article as an example:
Monday, July 12, 2004

GILEAD REDUCES COST OF VIREAD BY NEARLY 37 PERCENT FOR DEVELOPING COUNTRIES

Gilead Sciences, a biopharmaceutical company, said it will reduce the price of its HIV therapy Viread (tenofovir disoproxil fumarate) by nearly 37 percent of the original no-profit price for developing countries. The price reduction is due to improvements in the manufacturing process and increased economies of scale.

Through its Gilead Access Program, the firm offers the pharmaceutical brand name drug Viread at a no-profit price for African nations and 15 other "least developed" countries around the world, as classified by the United Nations.

The brand name drug will now be made available to any private or public program treating people with HIV/AIDS for $24.71 per 30-day supply, which represents Gilead's costs for manufacturing the drug and administering the program.

"Since the launch of this program, Gilead has continued to invest in process improvements that could reduce our manufacturing costs," said John Martin, president and chief executive officer. "Now that we have identified improvements, we are able to lower our manufacturing cost and consequently our not-for-profit price."

Additionally, Gilead intends to make a fixed-dose combination of the proprietary name drugs Viread and Emtriva (emtricitabine) available through the program as soon as Emtriva receives approval from the Food and Drug Administration. A decision is expected in mid-September.

Both brand name drugs Viread and Emtriva are indicated to be used with other antiretroviral agents for treating HIV-1 infection among adults.

[Roie]

Roie:  That may be true in Israel, but that's not typical.  It took me all of 30 seconds to dig up this article as an example:
Monday, July 12, 2004

GILEAD REDUCES COST OF VIREAD BY NEARLY 37 PERCENT FOR DEVELOPING COUNTRIES

And exactly which developing country are you planing to go to, to get your reduced price meds?
Is this really a realistic option?