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And, now, in an
attempt to justify such seizures, it is
evident that the Agency actually does
not even know what actions Congress has
taken in regard to personal importation
of prescription medicines.
These are the inescapable conclusions
after seizures recently started again.
This prompted us to submit a series of
inquiries to the FDA. The responses did
not directly answer the questions. Now
even more significantly, correspondence
by the FDA to which we have gained
access claims that "it is prohibited by
congress (sic) to purchase prescription
(sic) by mail."
Either the person making the statement
is completely uninformed or is guilty of
a deliberate falsehood.
As long ago as 2000, Congress approved
the concept of 'reimportation', a
misnomer since virtually no medicines
are produced in the U.S. and the
majority of prescriptions purchased in
the U.S. is imported from other
countries.
It was also passed in the last year of
the Bush Administration, only to be
turned away because it was attached to
the FDA Reauthorization Bill, and
President Bush had threatened a veto if
the bill contained provisions for
importation.
Added to this is the fact that for
nearly a decade, personal importation
has been supported by a huge number of
sponsors in the House of Representatives
and the Senate, only to be denied a vote
because of parliamentary maneuvering by
the highly effective pharmaceutical
lobby.
That U.S. citizens should be denied
access to vital, safe, affordable
medicines via individual purchases for
whatever reason best fits the moment for
the FDA indicates that the agency, even
in light of its failed record of safety
for a number of products, is willing to
allocate its limited resources to
hindering personal importation.
One can only wonder whether such actions
might actually do more harm to the
people whose health it should be
protecting by denying Americans access
to personal importation as an integral
part of their health regimen.
It is also reasonable to wonder whether
or not seizing of safe, affordable
medicines is done at the risk of
detracting from seizures of counterfeit
drugs from bogus pharmacies.
Some background is in order:
I have been and continue to be a strong
supporter of personal importation. In
that capacity I have worked—and continue
to do so-- with seniors’ advocacy
groups, policy-makers and as a
communications consultant for companies
that support importation of safe
affordable medicines.
I have contacted and been in the offices
of numerous Congressmen and Senators to
make them aware of past actions by the
FDA, Homeland Security and Customs in
denying seniors and untold numbers of
other Americans vital medicines that are
important to the health and well-being
of the persons ordering the medicines.
In 2006, we were successful in what, to
that time, had been the to that time the
most major abuse of power regarding
seizures when elderly people across the
country were not only having their
medicines seized, but were receiving
threatening letters from Customs
officials telling the seniors that they
were in violation of U.S. law.
This is, I and many others believe, a
debatable point depending on one’s
interpretation of the availability
statement on the FDA’s own site saying
that if a medicine or medical device is
not available in this country, an
individual may purchase it from outside
the U.S.
My view is that if a medicine is
unaffordable, it is certainly
‘unavailable’. Futher more, in an even
more abusive attempt to scare America's
elderly, in its letter, Customs went on
to force the individuals to acknowledge
that they knew they had violated U.S.
law and were subject to prosecution if
they continued to engage in such
behavior, namely ordering medicines that
helped keep them alive.
A sense of righteous indignation set in
among elected officials.
Then-Congressman
Gil Gutknecht (R-MN) offered to file
a friend of the court brief should
supporters of importation decide that
legal action be taken, his purpose being
to illustrate how the FDA, Customs and
Homeland Security were thumbing their
nose at Congress.
Senators Bill Nelson (D-FL) and
David Vitter (R-LA) sponsored
legislation to end the seizures, a clear
signal that it did not approve of the
actions of regulatory agencies designed
to enforce the intent of the Legislative
branch, not to design and interpret laws
and make policy.
It was evident that the FDA was denying
access to drugs that had not been tested
for safety and efficacy. This is a
crucial point since in the latest
communications with FDA, the agency now
(2009) says it does not have test
results to affirm safety and efficacy.
It does claim to have conduct tests and
found ‘some drugs’ to not be authentic,
but will not provide results from any
tests it might have conducted on
legitimate medicines. This leads to the
inevitable conclusion that it has made
its decisions whether to seize or not
strictly upon country of origin rather
than safety and efficacy
In 2006, the outrage over the seizures
led to what was described as a
‘historic vote’ as the Senate took
action, voting 68-32 to forbid such
seizures. (And, herein lies the
basis of the basis of the current
disingenuous rationale of FDA…which now
claims in verbatim statements that
follow that the legislation was directed
only towards Homeland Security, although
the
spokesperson for DHS at the time clearly
states that the department was working
in cooperation with FDA.
It is clear that the intent of the
Congressional action—an intent which it
clearly understood—was to defer seizures
of specific medicines and pharmacies
from acknowledged safe sources.
It was not aimed at hampering the
seizures of counterfeit medicines from
bogus pharmacies. Since the FDA,
according to the comments of other
agencies was cooperating in such
seizures, this intent was directed
equally towards all agencies involved in
the seizures.
The issue seemed to be settled with the
2008 Presidential election.
Both candidates supported importation of
safe, affordable medicines from outside
the U.S., and today,
Senator John McCain (R-AZ) remains an
outspoken advocate of importation.
Still, seizures have recently increased.
This led us to make contacts with an FDA
spokesperson to seek the rationale of
the agency for the seizures.
We had--and continue to have--several
questions, including whether increased
seizures might be a part of the deal
struck by PhRMA to 'lower' the price and
rate of increase of medicines in
Medicare Part D's Doughnut Hole.
That the claimed savings are illusionary
and have been challenged by many
policy-makers and advocates only adds to
the suspicion that there might have been
some 'quid pro quo' made by the
Administration in return for PhRMA's
'cooperation.
But, it is an ill wind that blows now
good. The responses to the series of
inquiries and later statements made by
other FDA officials in justifying
seizures of personally imported
medicines with a proven record of safety
and efficacy, and absolutely no record
of coming from bogus pharmacies or being
counterfeit is illustrative of an agency
that is suffering either from
miscommunications in defense of its
stance on such seizures, a complete lack
of respect for the intent of the U.S.
Congress, or a bias that indicates the
unwillingness of the FDA to stick to its
own guidelines as to its 'primary'
reason for seizures--or all of the afore
mentioned.
The FDA is a severely criticized agency.
It has failed to protect American
consumers from easily identifiable
sources of potential contamination of on
the medical front such as
failure to identify defective medical
devices from China. Even though it
claims concern for drug safety,
it failed to identify unsafe ingredients
from China are blamed for deaths from
Heparin, manufactured by Baxter.
It has also been criticized for failures
in protecting the U.S. food supply for
products ranging from
domestically grown peanuts to
imports of
unsafe foods from China.
It is a matter of public record that the
FDA has limited resources. So when we
made our contact with a staffer assigned
to deal with questions involving
importation, our first question,
submitted in writing was:
Knowing of admittedly limited resources of the FDA, how does the agency reconcile the seizure of proven safe medicines from legitimate pharmacies (albeit from outside the U.S.) with the possibility that dispersing those limited resources might actually increase the chances of counterfeit medicines from bogus pharmacies escaping seizures.The answer such as it is follows:
"Because of limited resources the FDA uses a risk based approach to detention and actions related to imported drugs"
This is a typical Public Relations approach in which one answers a question that was not asked. It fails to address the question that was asked, and is nothing less than a tacit admission that the people making the seizures have no idea of the safety or efficacy of the medicines.
The agency has made a decision that it is doing more to promote drug safety by seizing individual purchases of medicines than to allocate its resources, which the FDA admits are limited, towards identifying bogus pharmacies and counterfeit drugs.
If the FDA needs help in identifying and distinguishing legitimate pharmacies from other countries, whose standards of quality meet or exceed those of the agency, surely a measured and more effective use of 'limited' resources could be expended in working for reciprocal arrangements to identify those pharmacies. If it needs help to identify bogus pharmacies, I suggest the agency cooperate with the Canadian International Pharmacy Association which has worked diligently to identify bogus pharmacies, or that it take advantage of several other sources that have done so.
Another question asked was about the 2006 vote:
Congress voted to end the seizure of prescription medicines from licensed, registered pharmacies via Canadian pharmacies. How does the FDA reconcile that intent of Congress with the broad brush approach that such imported medicines are subject to seizure? Does the FDA supersede the Congress in this instance?The response follows:
“What you are referring to was directed to DHS authority. Under the FDA's current authorities, most of these drugs are illegal and unapproved.”
This is, as noted above, completely disingenuous. In a statement at the time of the vote, the following statement was issued:
A Department of Homeland Security spokesperson in a statement said, "While we are reversing this policy, (Customs and Border Protection) remains committed, in cooperation with the FDA, to protecting the American public from unsafe and ineffective medications. We will be focusing our resources to best protect the American public." An FDA spokesperson declined to comment on the decision to end the seizures.
This statement makes the record clear. Congress had a clear intention to end seizures. At the time, the FDA declined comment, buy its silence spoke volumes in light of the admission by DHS that the policy was conducted in cooperation with the FDA.
While the spokesperson for FDA provided written answers, most of them were as follows:
“Under current law, these products are illegal. Sometimes FDA does test products, and we have found substandard and counterfeit drugs.”
This led to yet another question:
Is the reason for such seizures continue based upon the point of origin, or has the FDA conducted any tests on the seized medicines from such pharmacies as described in (2) to determine the efficacy, quality, safety of the affected medicines? If so, what are the results of such testing? (For the record, (2) refers to “vital prescription medicines from licensed, registered pharmacies in other countries who standards of oversight meet or exceed those of the FDA?”The response follows:
Under current law, these products are illegal. Sometimes FDA does test products, and we have found substandard and counterfeit drugs.
The response seems to indicate that the FDA has indeed tested and found problems with prescription medicines from the designated Tier One countries.
But the response to a specific request indicates that this is not the case.
The question follows:
This is a request for the specific findings of substandard and counterfeit drugs from any licensed registered pharmacy from outside the U.S.
The response follows:
FDA does not have that information to share. Testing typically performed by the FDA relates to the identity and content of the product, and not to the efficacy, quality and safety of those products.
And therein lies the self-imposed dilemma of the FDA.
It admits that it has not only has no reason for making seizures based on safety and efficacy of the legitimate vital medicines it has seized, but instead relies upon country of origin. Add to this, the attempts to twist the intent of Congress on forbidding such seizures, and the complete misstatement about Congress forbidding the purchase of prescriptions via mail. All lead to questions about the real intentions of the FDA.
And, we can only wonder if, while seizing vital medicines, how many shipments of counterfeit drugs from bogus pharmacies might have slipped past inspectors