Therapeutic goods in the United States comprise most medications and are regulated by the U.S. Food and Drug Administration (FDA), which makes some drugs available over the counter at retail outlets and others by prescription only. The intent of the FDA is to require a valid prescription for therapeutic goods classified as prescription only. However there is a huge grey area for legitimiztion of online pharmacies because of their FDA manufacturing compliance as well as the excessive cost of therapeutic goods for uninsured, under insured and seniors on low income. Several state have programs legalizing online non prescription pharmacies. Therapeutic goods imported from Canada are allowed if they meet certain FDA conditions. Learn more

 Offshore non prescription pharmacies answer the question: “Is it legal to purchase online with out a prescription”. Their answer:  “Yes, because generic product is shipped from different countries, and depending on the medication, laws in that country do not require that you have a prescription”. This response is a true reflection of FDA policy. The FDA defers to the country of origin regarding dispensing regulations and credentialing of pharmacists or suppliers. In other words the FDA has no interest in prosecuting the overseas supplier or the U.S. consumer. 

 Non-controlled substances (therapeutic goods) comprise most of the medications used to treat common diseases including: ED products, certain weight loss produces, antidepressants and antibiotics. These are considered to have a low potential for abuse or dependency. The FDA regulates and enforces non controlled substances.

 Controlled substances are categorized, evaluated and enforced by the Drug Enforcement Agency (DEA). The uses of these substances have a high potential for abuse and dependency.  Some of these substances are staples in the medical community and some are illegal street drugs. Examples of illegal street drugs are Heron, Ecstasy, and Peyote. Examples of medically recognized products are Vicodin, Codeine and Morphine.

 The 1970 Controlled Substance Act (CSA) was enacted into law by the Congress of the United States as Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970. This act only addressed controlled substances.

 In April 2009  the Ryan Haight Pharmacy Protection Act an amendment to the CSA which targeted internet sales of controlled substances was enacted into law. While this amendment applies to controlled substances the conceptual implication could be applied to non-controlled substance. However the language again excluded the consumer as a culpable party in any illegal sales from the internet.

Ryan Haight provides additional clarification of  the the term “valid prescription”. This is important for internet sales of controlled substances however therapeutic goods fall outside this legislation. The lawyers see this as a huge vote in favor of online and overseas pharmacies. Their interpretation leaves the door open to legal wrangling. But the larger implication is this was deliberate to allow non-prescription offshore therapeutic goods a clear path to the U.S. consumer.

In our case there were four items that were prohibitively expensive through the AARP / United Healthcare plan. These expensive items were exhausting our allowance prematurely. The most expensive AARP drug plan items were around $5.00 per pill vs. $0.50 per pill off plan. When we went over the allowance we had spent $2,200 of the $2,700 on these four items.  Here are the details of the savings in our case.

Example of savings delivered by Canadian pharmacies:

Validate per pill pricing:
Plavix (Clopidogrel Bisulfate)
Tricor (Fenofibrate)

This article is divided into four parts.

1. A strategy for abandoning AARP and using Canadian meds plus Wal-Mart $4.00 generic.

The subscriber expenses for the AARP plan are $2,151. If you’re total bill for meds is less then this it’s more cost effective to abandon the plan.  To determine if this is so in your case review your AARP billing and determine your big ticket items. Then see what these items cost from Canada. Our cost for getting everything from Wal-Mart ($4.00 generic) except the four big ticket items was $500. Our big ticket items from Canada cost $1,350.

Canadian only – abandoning AARP:

Canadian               $1,350              No AARP or part D.
AARP                     $   500              Wal-Mart $4.00 generic and other low priced meds.
Gap copay             $       0              Coverage gap pay 100% after $2,700.
Total year              $1,850              Save $2,000 over worst case.

2. A strategy for a mix of AARP / Wal-Mart and Canadian:

The subscriber expenses for the AARP plan are $2,151. We were getting a mix of generic $4.00 items from Wal-Mart and some expensive items from the AARP plan. By September we were $300 over the allowance of $2,700. Buying the four big ticket items from Canada for the rest of the year cost $350. If we did not go over the allowance we could have reduced our total spend by $200 and stayed within the allowance.

Supplement AARP with Canadian: (actual spend 2009)

Canadian               $   350             Off plan Canadian.
AARP                     $2,151             Total subscriber expense – see details below.
Gap copay             $   300             Coverage gap pay 100% after $2,700.
Total year              $2,801             Save $1,000 over worst case.

3. A case for not using AARP only:

This case is a based on our exceeding the allowance in September and paying 100% copay for the rest of the year. In our case we would have paid an additional $1,500 copay and never reached the stop loss threshold of $4,350.

AARP only – no Canadian: (pay 100% copay AARP coverage gap – to $4,350)

Canadian               $       0             Off plan Canadian.
AARP                     $2,151             Total subscriber expense – see details below.
Gap copay             $1,800             Coverage gap pay 100% after $2,700.
Total year              $3,951             No savings – worst case scenario.

4.  Details of the AARP plan as well as actual billing for 2009.

The AARP/United Healthcare insurance provides a drug plan which requires social security part D.  This plan is aggressively marketed by AARP/United Healthcare. Large segments of the senior population have signed up for this drug plan.

AARP drug plan structure:

Annual deductible                 $295
Initial coverage                     Up to $2,700 in total drug costs.
Coverage gap                         After $2,700 in total drug costs; up to $4,300 in copay.
Catastrophic coverage          After $4,300 in out of pocket (copay) no limit.

It’s important to recognize the following:

1. The primary benefit is $2,700 worth of drugs.
2. The $2,700 is combined copay and plan pay.
3. The coverage gap is $4,350 of copay only. – 100% your money.

The following represents the total of subscriber payments. There are four elements of expense to the subscriber. These are actual figures are from a family member’s plan.

• Premiums                                 Month              Year
• Medicare Part D                          $40               $   480
• AARP Rx Plan                               $23               $   276
• AARP Deductible                                             $   295
• Co-payment                                                     $1,100
• Total year                                                         $2,151

The actual benefit to the subscriber is as follows:

• Allownce                                   $2,700   Combined subscriber copay and plan pay.
• Co-pay                                     - $1,100   Subscrber copay.
• Actual benefit                           $1,600    Plan pay. 

• Plan benefit                              $1,600
• Plan expense                          -  $2,151
• Actual plan benefit                  ($ -551) – loss

The primary benefit of $2,700 allowance includes co-pay and plan pay.  Deducting the co-pay of $1,100 from the $2,700 allowance produces an actual benefit of $1,600 and a net loss of $551.

The following are actual bills we received. The 07/31/09 billing shows us $279 short of the $2,700 allowance. The 09/30/09 billing shows us $300 over the $2,700 allowance.

07/31/09 billing shows “Stage 2” approaching the $2,700 allowance.

_____________________________________________________________________________________

_______________________________________________________________________

This bill shows us in “Stage 3” over the $2,700 allowance by $300.

_______________________________________________________________________

There are currently over 40 million people who are uninsured or under insured and cannot afford prescription medications. Most of us have felt the pinch of health care expenses. It seems that we contribute more to our premiums and co-pays than ever before.

There are a half a million American’s falling out of the job market every month. Paying extend medical benefits is in many cases prohibitivly expensive if you loose your income. There is a large segment of the population that needs relief from the high cost of pharmaceuticals. I am offering a solution to the high cost of meds which will provide relief for this growing segment of the population.

I was introduced to online pharmacy savings by my father-in-law who used this avenue to manage his AARP-United Healthcare drug plan allowance. Learn more.

There are considerations related to safety, purity and effectiveness that are insured by our FDA (Food and Drug Administration). Learn more.

We all want safe and reliable pharmaceuticals. There are offshore supplier issues that concern each of us. We want to know that the source of our pharmaceuticals are regulated and inspected by proper authority.  This fits together in a complex relationship of vendor, supplier and regulator. Learn more.

The upcoming health care reform legislation highlights the urgency of resolving some of the prohibitively high cost of services. The new legislation targets the insurance industry that controls healthcare delivery.  This implies the high cost of drugs will not be resolved by the new legislation. I believe there will continue to be price benefits to be gained by using online pharmacies. The cost of drugs will continue to be prohibitively expensive for millions of Americans.

I would like to close this article with a positive personal experience. These offshore suppliers are able to pass on mind boggling savings. They can produce FDA quality product for about five cents on the dollar. I will give two examples. First example: I ordered some generic product that was to be in tablet form and it came as a capsule.  My interest was being able to cut the tablet and get a more economical per pill cost.  I called and told the vendor’s representative, I was expecting a tab and got a cap. The representative said no problem we will send a replacement tab order. I enquired about returning the cap order. The representative said they were not expecting to have the incorrect cap order returned. Whew – I was impressed. I got to keep a double quantity for the price of one order. But I thought how can they do that?  The implication is that production costs must cover this eventuality. I don’t know the precise details but the message was clear. They can deliver meds at a dramatically reduced cost.  Second example: Some vendors offer a 20% coupon for initial order and a reorder price reduction of 10% or 20% more product.  So there is a pretty big margin some where. All this on top of a 90% lower price point than paid in the first world markets.  Think about that. – Wow!