For some time, I
have suggested that the U.S. Food and Drug
Administration (FDA) has operated on a faulty premise regarding the
personal importation of safe, affordable brand-name medicines from Tier One
countries.
We havesupported our stance with numerous blogs athat illustrate thatpersonal importation is safe, that it offers tremendous savings, and should bea primary element of reducing the cost of prescription medicines for individuals and even of our nation’s fiscal crisis in which increased costs of
healthcare are a major driver of our budgetary crisis, and the continued
increased costs of prescription medicines are a major driver of healthcare
costs.
That is why
we—and other advocates across the country—support personal importation of
brand-name medications from Tier One Countries, those that have standards of
safety and efficacy that meet or exceed those of the United States.
We have
suggested that the FDA itself enter into arrangements with the regulatory
oversight agencies in those countries that would establish reciprocity that
reflects that the majority of medicines taken by Americans are manufactured
outside the U.S. , and that a growing volume of ingredients used in the
manufacture of medicines, even those produced in the U.S., come from sources
outside the U.S.
In effect, the
FDA and the Pharmaceutical industry (Pharma) have engaged in a form ofimportation they would deny to the more than one million U.S. citizens that have found relief from the prescription medicine prices in the U.S. are the highest in the world.
That is why we
were encouraged by the decision by the FDA in mid-2011 to enter into ‘working
agreements’ with regulatory agencies in
other countries regarding ingredients used in the manufacture of prescription
medicines. Admittedly, the FDA’s intent
was directed only towards ingredients, but many advocates of personal
importation contend that if the working agreements (read, ‘reciprocity’) can be
applied to particular agreements approving oversight of ingredients, it is only
logical that such arrangements can be extended to those countries in the
‘approval’ and oversight of medicines imported from within their jurisdiction.
Now, two
independent studies—one from a private source, the other, ironically from the
FDA itself, lend further credence to this position.
The first, ‘Unveiling the Mystery of Online Pharmacies:an Audit Study’, is from the National Bureau of EconomicResearch (NBER) validating the claims of
supporters and advocates that personal importation of brand-name prescription
medicines from reputable sources outside the U.S. is both safe and cost
effective.
The other is a
study of the Institute of Medicine (IOM), requested by the FDA itself, to study
the question of improving the agency’s ability to work with regulatory agencies
in developing and other countries to, as the title of the report states,
‘Ensuring Safe Foods
and Medical
Products Through Stronger Regulatory Systems Abroad .”
Highlights from each of the reports reflect favorably upon the concept of
personal importation, the former from the viewpoint of safety and cost, the
latter from the viewpoint that the mechanisms are in place in ‘developed
countries’ to ensure the safety and
efficacy of ingredients—and, personal importation advocates would contend, that
of imported medicines approved by the regulatory agencies in those countries,
of personally imported medicines.
The NBER report notes: “Focusing on five brand-name prescription drugs,
we acquire 370 drug samples from 41 online pharmacies and test their
authenticity. Of the 41 websites, 8 are clearly US-based and verified by the
National Association of Boards of Pharmacy (NABP) or LegitScript.com. We refer
to them as tier 1. Another 23 websites – referred to as tier 2 – are not
verified by NABP or LegitScript but verified by PharmacyChecker.com or the
Canadian International Pharmacy Association (CIPA). ”
Significantly, the study found “… that according to our Raman
spectrometry test, no failure of authenticity is found in drugs that came from
verified websites, the only failures are Viagra from non-verified websites in
tier 3. Second, within verified websites, tier 1 websites on average charge
52.5% more than tier 2 websites in final price (including shipping and
handling) for the same drug and dosage.”
From a political perspective, one of the more significant aspects of the
NBER report is that a major participant in the survey is Roger Bate, a
well-respected free-market, Libertarian economist and contributor to the American Enterprise Institute.
I say significant because traditionally support of personal importation
of prescription medicines has come from policy-makers considered more liberal,
and who would rely upon governmental policy—such as the annual reincarnation of
the failed (many times) Dorgan-Snowe bill establishing what supporters hoped
would provide a mechanism to ‘ensure’ the safety of personally imported
medicines.
In addition to Bate’s involvement, this stance is strengthened by the
continued support of Rep. Ron Paul (R-TX) whose personal importation bill is a
model of simplicity, especially when compared to the latest version of
Dorgan-Snowe. Senator Byron Dorgan (D-ND), who retired from the Senate before
the last election was a champion of personal importation.
In the latest version
of the legislation, Senator Olympia Snowe (R-ME) is again a co-sponsor, and
Senator Debbie Stabenow (D-MI) has stepped forward as the co-sponsor.
Senator Snowe’s announcement that she plansto retire after her term ends in this session makes it almost certain that
there will be no legislation forthcoming this year.
While the NBER
report validates the authenticity of and cost savings of brand-name medicines
via personal importation, the findings of the IOM study can be construed as a
validation of the concept of reciprocity because of its conclusions regarding
cooperation with agencies in other developed countries.
The reports notes that “… more than 80 percent of active pharmaceutical ingredients—the building blocks of medicines—are imported, and 40 percent of medicines are imported as finished products. Further, U.S. imports of medical devices quadrupled over the last 10 years…”
The significant
conclusion reached by the IOM report, while supporting the FDA plans to strike
reciprocal agreements to extend scarce resources also sets the stage for calls
for partnerships with developed countries noting:
“The
FDA should use partnerships to drive improvements in supply chain management…The
committee recommends that the FDA work with strong regulators in other
countries to plan inspections and pool data.”
“The
FDA should use partnerships to drive improvements in supply chain management…The
committee recommends that the FDA work with strong regulators in other countries
to plan inspections and pool data. There is no need for American and European
inspectors to duplicate each other’s work, especially when a vast number of
facilities go uninspected.”
We contend that
this meets at least one definition of reciprocity: “…the relation or policy in commercial
dealings between countries by which corresponding advantages or privileges are
granted by each country to the citizens of the other.”
We also contend
that such action will enhance the role of personal importation of safe,
affordable brand-name medicines, providing enhanced health and contributing tothe physical and fiscal well-being of millions of Americans—perhaps as criticalan issue today as it has ever been as millions of Americans forego following aprescribed regimen of vital medicines because of the high costs, and as our
country faces a Tsunami of healthcare costs, driven, in good measure , by thosesame high costs.
