St. Louis,
October 8, 2012—The publisher of www.TodaysSeniorsNetwork.com,
America’s leading informational website for issues affecting an aging America, says
that the Food and Drug Administration (FDA) should extend its recently enacted
policy of reciprocity with other countries to improve the safety of prescription
drug ingredients manufactured in those countries for export to the U.S to personal importation by Americans of
medicines produced in those countries.
Daniel Hines
noted that virtually all medicines sold in the US are manufactured outside of
this country, and that access to safe, affordable brand-name medicines from
licensed, registered pharmacies in Tier One countries—those with standards of
efficacy and oversight that meet or exceed those of the U.S.—provides the only
relief for vast numbers of Americans who must either pay the highest costs for
prescription medicines in the world, or choose to do without their vital, often
life-saving medicines.
“The US is a
safe-haven for the highest prescription medicine prices in the world, which is
the reason that millions of Americans have turned to personal importation as a
vital lifeline to their medicines—the very same medicines sold in the US at
prices as much as 60 percent higher,” Hines explains.
“The actions
of the FDA to establish reciprocity with regulatory agencies in countries
outside the U.S. is an admission by the FDA that such cooperative arrangements
can be accepted as providing the oversight that will validate the safety and
efficacy of not only ingredient manufacture but of pharmacies, as so many
advocates on behalf of personal importation have urged,” Hines says.
“The problem is that, by confusing in the
minds of the American public, bogus pharmacies with personal importation that
has a proven record of safety and efficacy built by providing vital medicines to
Americans for many years there could be unintended consequences adversely
affecting the health and well-being of millions of Americans.”
While
lauding the stated intent of a new FDA website ostensibly designed to help patients
identify bogus, illegal pharmacies issuing counterfeit medicines as “an
admirable goal”, he notes that “by limiting its ‘acceptable’ guidelines to
domestic pharmacies, the FDA has missed a tremendous opportunity to extend its
earlier announced policy of reciprocity and cooperation with regulatory
agencies in other countries to improving competition, price-relief and enhanced
health for Americans.
“In a recent
interview, a Consumer Reports spokesperson described bogus pharmacies as being ‘like
gopher holes that pop up everywhere even after being shut down.’
“That is why
we urge the FDA to recognize that it might adversely affect legitimate and safe
sources of medicines, forcing untold numbers of Americans to either curtail
their vital medicines because they are unaffordable in the US—or, more
troublesome, leaving only bogus
pharmacies to which unknowing patients might unwittingly turn.
“The result with be an endangerment of the
health and well-being of huge numbers of Americans. And therein lies the unintended
consequences in which good motives go wrong, “ Hines says.
He
identifies three steps that the FDA should take to remedy this dilemma:
·
The
Secretary of Health and Human Services should direct the FDA to extend its
policy of reciprocity regarding manufacture of ingredients and medicines with
regulatory agencies of other countries by exploration of processes to identify
those pharmacies that are licensed and reputable;
·
In
light of repeated favorable votes in favor of personal importation, Congress
should also direct that the FDA as a matter of public policy extend the policy
of reciprocity to personal importation;
·
The
FDA should clearly identify to Congress and the American public clearly
identifiable bogus pharmacies, and its strategies to deter their access to
selling counterfeit medicines;
“Such actions will be a clear sign that the
health and well-being of Americans is a primary goal of the FDA,” Hines
concludes. “It will also be a clear
signal to Pharma that the FDA recognizes that the cost of prescription medicines
in the US is a major driver of healthcare costs, and without clarification of
the beneficial impact of personal importation upon American’s physical and
financial health, the limitations of the new website will indeed have
unintended and adverse consequences.”
