Monday, September 28, 2009

Has FDA reached its hubris with its disingenuous approach to justification of seizures of vital medicines, by thumbing its nose at Congress

Recent FDA seizures of individual purchases of vital, safe, affordable medicines from licensed, registered pharmacies in countries outside the U.S.—countries which have standards of oversight that meet or exceed those of the U.S. and our FDA—and statements made to justify such seizures illustrate that the agency has no appreciation or respect of the intent of Congress to end such seizures as well as engaging in disingenuous actions by claiming that any past Congressional actions do not apply to it. 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

Sunday, September 13, 2009

Questions arise about motives of Senator Vitter regarding stance on prohibiting seizures of imported medicines

The motives of Senator David Vitter (R-LA), one of the traditional supporters of importation of prescription medicines from outside the U.S., have come into question because of the Senator’s response to a question from a participant in a Town Hall meeting and the lack of response to inquiries made to the Senator’s office about reports of stepped-up activity of seizures of vital medicines from legitimate, registered pharmacies in Tier One countries—medicines intended for individual purchase by U.S. citizens.

That this should occur involving the Louisiana Senator is somewhat of a surprise, since he has been a supporter of importation legislation, even introducing his own version of bills in past sessions of Congress.

Also, he has a record of supporting the rights of individual purchases of safe, affordable prescription medicines, and was a leader along with Senator Bill Nelson (D-FL) in passing legislation forbidding the seizure of prescription medicines in 2007. We worked closely with the staff on board at that time to support the legislation. He was known as being friendly to issues involving not only individual access to imported medicines but those affecting the elderly as well, serving on the Senate Select Committee on Aging. And, to add to his credentials, he was successful in pushing through Senate approval of legislation to prohibit funding being used to seize prescription medicines in the next budget year.

An admirable record, indeed. So what is the problem?

With his answer to a constituent’s question at a Town Hall meeting in which the questioner suggested that by supporting such legislation to prohibit seizures, the Senator was actually saying that because of lower-priced medicines being available from Canadian pharmacies (an issue we’ll discuss shortly because it does not reflect the realities of the current situation involving sourcing for legitimate Internet-based and mail order pharmacies), the Senator was actually commending the Canadian Healthcare System.

Senator Vitter’s replay was disingenuous, to say the least. Instead of reaffirming his support of the rights of individuals to make such purchases, he retreated to pandering to his audience, saying that his real goal was to force prices in Canada to increase, so that the pharmaceutical industry could lower prices in this country. He actually went so far as to suggest that his legislation could cause the collapse of the pricing methodology not only in Canada, but to create a worldwide collapse of pricing structures of other countries, and that they would be forced to increase their prices and the drug companies would show a charitable side to the American public, which has been besieged by predatory pricing of the pharmaceutical industry for decades

Oh yeah, and I have some beachfront property in Arizona to sell you.

Perhaps the reason the Senator believes that even though he pushed his bill through the Senate that the real reason that it would not be in any final bill coming out of the Senate-House conference was that his colleagues know that his real motive is not to lower drug prices in this country by ensuring the right of access for individual purchases and increasing the options available, but is merely an unworkable attempt to walk on both sides of this issue.

This is disappointing because several years ago, we worked with previous staff in the Senator’s office, and enjoyed such an amiable relationship that we were invited to participate in a Senate Aging Committee hearing that the Senator was planning in New Orleans. Unfortunately, a series of events forced the cancellation of the planned hearing.

Still, because of the Senator's record as a supporter of personal importation of safe, affordable medicines, we extended an invitation to current staff to respond to questions about the seizure ban legislation and related issues. The staff has declined to respond, creating additional questions about the Senator’s commitment to importation, and even of his commitment to presenting his views to America’s seniors. This is especially disheartening in light of his position on the Senate Select Committee on Aging.

Perhaps it is just as well. The Senator’s anti-seizure bill is unlikely to gain any traction and will not be a part of any Conference Committee agreement. This is unfortunate, especially in light of questions about what PhRMA received in return for its decision to cut prices for seniors in the Doughnut Hole. Did it ‘negotiate’ that there would be no price negotiation for Part D? Did it receive an understanding that there would be increased seizures of individual, personal orders of prescription medicines from outside the U.S.?

A final note: Earlier, we mentioned that the Senator’s bill to halt funding for seizures of medicines is flawed. In that regard, it shares with the Dorgan-Snowe bill for importation of personal medicines a fatal fault because the language of both reflects reliance upon importation of prescription medicines from Canada as well as not comprehending how the landscape for importation has changed over the years.

The problems

(a) Where at one time there were more than 140 mail-order or internet pharmacies in Canada, today the membership of the Canadian International Pharmacy Association is 31 pharmacies;

(b) The primary souring for the medicines dispensed by these is not Canada, but from licensed, registered pharmacies in other countries with which the Canadian pharmacies have established relationships and oversight that complements the standards of the country in which the pharmacies are located. The Senator’s bill limits the seizure ban to medicines from Canada;

(c) Finally, the Senator’s response to the question from the Town Hall meeting raises serious questions about his commitment to the role of importation as a part of a strategy to lower prescription medicine prices in this country. Canada has made it clear that it will not become America’s drugstore and will take whatever steps are necessary to protect its citizens and keep prices low.

(d) His belief that his stance will destroy not only the Canadian Health Care pricing structure but that of the rest of the world by forcing other countries to raise their drug prices, and that pharma will respond by lowering prices in the U.S. because it is able to charge more in other countries would be laughable were it not yet another example of the inability of many of our elected officials to understand the role that personal importation of prescription medicines could play in reducing prices and healthcare reform.

Wednesday, September 9, 2009

Dear Mr. President...an appeal to President Obama for his healthcare speech

Dear Mr. President:
Once again, you have been placed at the crossroads of history. Tonight (September 9) you will have an opportunity to regain the impetus of the need for real change that was delivered to you by the American people last November.

As one who foresaw you as the next President long before others had even thought of it, I urge you to use this chance to reclaim the mantle of leadership which, unfortunately and disappointingly, you gave to the Congress and the shrillness of the Town Hall Meetings in August.

As you prepare your remarks and as you reassume the mantle of leadership that is unique to the Presidency, remember some important points:

o You are the only elected official who has subjected himself to the extreme scrutiny of the American people.
o You are the leader of the Democrat Party, and alone have a national vision that will address a multitude of problems, including but not limited to healthcare.
o The people who disrupted the democratic process of Town Halls are a shrill minority. Yes, there were those who have legitimate concerns, but there are two things that abhor a vacuum--nature and communications. Something will always fill the vacuum, and in the Summer of 2009, it was, unfortunately a small, albeit loud and disruptive, number of people with a particular agenda aimed directly at usurping the results of the past three elections.

So, Mr. President, here is my suggestion. Speak plainly, not professorial. Tell people what you are going to tell them, tell them and then tell them what you have told them.

Take the playing field of the 2010 elections away from those GOP House and Senate members who are already envisioning their elevated roles in a new Congress by making it clear that you are willing to layout your proposals, that the Democrat Party stands ready (at least in large part) to stand with you and on behalf of the American people who need and deserve affordable healthcare.

Then, stake your position. Let it be known that your confidence in the correctness of what you and others are doing is such that you have full faith in the ability of a majority of the American people to do the right thing.

This will provide a voice for those of us whom have believed in your ability to provide the leadership to implement needed change. It will also reflect your confidence in the basic goodness of the American people. And, it will show that you realize that your ability to govern is based upon continuing to merit the trust and support of the country.

With all best wishes,
Daniel Hines