Dorgan-Snowe needs changes

Sometime ago, we published a blog suggesting that problems that we perceived with the proposed prescription medicine importation bill, based on our understanding of input from key staff and communications with other supporters of the concept of the prescription medicine importation led us to fear that key elements of the concept that have long been supported by groups and advocates might somehow not be included in the new legislation.

It was that concern that prompted us to call for increased public participation in the development of the language. Irrespective of what the outcome might have been for our appeal, we believe that such involvement is not only a right given to U.S. citizens, but an obligation for those whom we elect to serve and govern--not rule.

Our specific concerns were that we and others have long believed that it is the right of U.S. citizens to make purchases from Tier One countries, where the regulations, oversight and supervision of pharmacies meet or exceed those of the United States.

We were challenged on this by a visitor to the article who wanted our source to validate the statement. She speculated that it was likely a political reference and tht the FDA had not reached such a conclusion. Of course, she was right on the latter aspect, since the FDA would never face the wrath of pharma by stating the obvious. In the former instance, though, she was just wrong. The fact is that each of the Tier One countries have outstanding regulatory oversight, and it is well-recogized by healthcare professionals and authorities around the world that not only do those countries have standards that meet those of the U.S. and the FDA, but that we as a country are unforunately far behind the standards of those countries.

Which leads to our former concerns about the proposed importation legislation that was was introduced on March 4. We feared that the ability of U.S. citizens to purchase physician-prescribed medicines from Tier One countries was to be limited, and would allow the purchase of medicines from those countries only if they were first purchased by a U.S. importer (a pharmacy, group of pharmacies, or a wholesaler) for resale to Americans.

This seemed to be an unnecessary restriction that would only add to the costs, while doing nothing for safety or efficacy of the medicines.

Unfortunately, the latest 'wrap' explanation of the bill seems to reinforce this view.

After much discussion, and readings of the bill regarding the limitation on individual purchases we came to the mistaken conclusion that the Secretary of HHS would be able to 'designate' particular countries as having standards of oversight and regulation that met or exceeded those of the U.S. and that individuals would be allowed to make purchases from those countries.

The latest explanation of the proposed language has disabused us of our mistake. To the contrary of what we believed, it reinforces our earlier fears and limits direct purchase to mail-order or Internet pharmacies located only in Canada.

This would take effect 90 days after the passage and signing of any importation bill. At the same time, it would be a year before the 'commercial' setup that would allow American citizens to purchase those same medicines from designated countries, and then only from a wholesaler or a U.S. pharmacy.

As one who has supported the concept of importation of medicines from legal, authorized, licensed pharmacies for nearly six years, it is difficult to express my dismay at this short-sighted approach to increasing the access of Americans to safe, affordable prescription medicines--especially at a time when growing numbers of elderly are either reducing or doing without vital medicines because of the problems associated with the Doughnut Hole. And that is only the tip of the iceberg.

Millions of Americans irrespective of their age simply cannot afford their medicines, so they too do without. Ironically, this occurs at a time when there is a solution--expand the ability of Americans to have increased access to safe, affordable medicines, exercising their own good judgment by utilizing the many sources that identify legitimate, safe pharmacies in Tier One countries.

As a writer from the American Enterprise Institute (no friend of importation) noted recently, "Only an idiot would purchase 'medicine' from a bogus pharmacy" because there are many sources than can identify legitimate pharmacies.

The legislation has been referred to the Senate Health, Education, Labor and Pensions Committee and to the House Energy and Commerce committee. Hopefully, there will be hearings at which public testimony will be solicited--and listened to--as part of the democratic process.

I have been told that I am covering old ground. Perhaps that is true. But the facts are evident: importation from licensed, registered pharmacies is a fact and even with (or perhaps because of Part D), it offers a reasoned solution to allowing Americans to have access to vital medicines; to the best of my knowledge, there have been no deaths from any medicines from these pharmacies; no controlled substances have been shipped to this country from these pharmacies.

And,whereas there was no track record when the push for importation first began, and it would have been necessary to establish safeguards to protect and reassure the American public, there is no guarantee that even with passage of the legislation in its current form that it will end or even curtail bogus pharmacies, sales of controlled substances or sales of counterfeit drugs.

The concept of importation, free choice and equitable pricing, with the goal of improved health that can be attained through a regimen of access to safe, affordable medicines remains valid. The challenge now: to establish the framework that will make it happen.