Wednesday, December 16, 2009

American Public has common sense answer to lowering drug prices…just do it!

The failed vote in the U.S. Senate on the Dorgan Amendment to ‘allow’ lower-cost prescription medicines from licensed, registered pharmacies located in countries that have standards of oversight that meet or exceed those of the U.S. was both tragic and unnecessary.

It was tragic to watch the tremendous courage of Senator Byron Dorgan (D-ND), a man whom I greatly admire, who has been a champion of lowering prescription drug prices through ‘reimportation’ for nearly a decade, as he pleaded, cajoled and passionately made the point that the amendment was truly the only one that would have the effect of providing savings.

It was equally tragic to see him victimized by the deal-making of the Obama Administration with PhRMA. The snake that the President has decided to pick up may still bite him, as we warned in a previous entry.

At the same time, the spectacle was unnecessary. There are several reasons:
• As we have noted before, and even though we strongly support the right of personal importation, the bill, popularly called Dorgan-Snowe, was unworkable. It relied upon assumptions that simply were not possible to achieve:
• The first-year limitation upon medicines coming only from Canadian mail-order pharmacies was naive.
• There simply are not enough mail-order pharmacies left in Canada to provide the hoped-for funding;
• By restricting the ability to purchase medicines immediately from Australia, New Zealand and Great Britain for one year, and then limiting even those purchases to U.S.-based wholesalers and pharmacies, the bill’s supporters failed to acknowledge that as much as 80 percent of the sourcing for the Canadian mail-order pharmacies comes from Australia, New Zealand, and Great Britain.
• This was not the case when ‘reimportation’ first became an issue, but while the situation has changed, the language of the amendment reflected a situation that simply no longer exists, that of several years ago. It appears that the hoped-for impact was that since President Obama had co-sponsored a bill with virtually the same language two years ago, as had his Chief of Staff Rahm Emanuel on the House side, that they would be so flattered as to support the reincarnation of ‘their’ bill, a surprising bit of naivete.
There was no opportunity for public input into the formation of the language. Supporters were given a ‘love it or Lump it’ choice. Some accepted this direction. I never did, not because I did not support the concept of importation, but because after years of hard work and support for personal importation, my responsibility remains the health benefits and savings that personal importation generates for seniors, workers, and others, not the mere passage of a bill.
• Many of the supporters of importation failed to ask themselves a very basic question: Why should Canada, which is a sovereign nation, and which through Health Canada has standards of oversight that meet or exceed those of the U.S. FDA, allow its pharmacies, operating completely within the laws of Canada and the provinces to be subject to U.S. inspections. Rather, why was there not a move made for reciprocal agreements?

But, in addition to being unworkable, there is another reason the amendment as written and the punishment heaped upon importation supporters was unnecessary: Importation of safe,affordable medicines is well-established through the common sense of the American public.

As the pharmaceutical industry continues to raise its prices, making deals with the Obama Administration that will lead to even greater costs for Medicare Part D payments by the government, growing numbers of Americans will be able to make wise, independent evaluations of safety and efficacy, as well as costs of medicines from safe, easily identifiable sources, not only from Canadian pharmacies, but through other pharmacies in Tier One Countries.

This is yet another example that all wisdom does not generate from within The Beltway but lies with the common sense of the American people.

For years, we have contended that individual, personal importation is allowed because the FDA itself has stated that a medicine that is not available in this country may be ordered in 90-day supplies for personal use, and any medicine that is not affordable is equally unavailable.

Also, that same common sense, enables Americans to evaluate the sources of their medicines for safety and efficacy as well as price. Those who believe that the FDA is the sole source of drug or product safety need to only look at the sorry record of the agency on a number of fronts ranging from Peanuts to Heparin.

As one who supported President Obama during his Presidential quest, I must admit to a deep sense of chagrin on a number of fronts. The deals with PhRMA are just the latest in a series of failed pledges for transparency and openness in government.

If Senator Dorgan wants to proceed with his quest, I encouraged him take actions that reflect the realities of the moment, rather than a bill with language that, while deserving support in a different time, is no longer relevant…irrespective, we shall increase our efforts to help the American people have the information to make informed, wise decisions, step forward, and exercise their common sense with the selection of safe, affordable medicines from pharmacies in other countries that meet or exceed the standards of those in the U.S.

Perhaps the President can then redeem himself by directing HHS to take steps to lead to reciprocal agreements with those countries for the benefit of the health care needs of untold numbers of people in this country. But, it is not necessary to wait for him or others within The Beltway to take action.

The American people have already spoken and as they are faced with the tremendous price increases initiated by pharma, we urge advocates of lower drug prices to help provide them with the information that will help them make the purchase decisions that will solidify the role of vital medicines in their healthcare regimen.