Recent findings of two separate studies should nudge FDA to reciprocity

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. 

However, after many failures, and with the changing tide of politicalsentiment in the country, we and others suggested that it might actually be theconservative movement with its emphasis upon personal responsibility and afaith in the ability of the American people to make intelligent decisions aboutpurchases of safe medicines from outside the U.S.

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.