Making the case for personal importation of safe, affordable prescription medicines from licensed, registered pharmacies in Tier One Countries. Rx for American Health is published by Daniel Hines, an international award-winning communicator with five decades of experience, and the publisher of www.TodaysSeniorsNetwork.com and www.BoomersNewsOnline.com. He also works with progressive senior advocacy groups across the nation to promote the health and well-being of America’s aging population.
Sylvia Mathews Burwell
Secretary, Health and Human Services
The U.S. Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201
Dear Secretary Burwell:
I am writing to offer my congratulations to you on your nomination and assumption of the duties as the Secretary of Health and Human Services.
Among the many challenges you will face as Secretary will be the continuing problem of the costs of prescription medicines, an issue that forces as many as 50 million Americans to forgo adherence to a regimen of taking vital medicines because they simply cannot afford them.(1)
This threatens the health and well-being ofhuge numbers of Americans.That is why so many individual Americans, groups, and local and state governmental entitieshave turned to personal importation of brand-name prescription medicines from Tier One Countries, whose standards of safety and efficacy meet or exceed those of the U.S.
And that is why I must alert you to the potential harmful impact of rules that are being promulgated for Section 708 of the Food and DrugAdministration Safety and Innovation Act(FDASIA).Section 708 would allow the destruction of a drug valued at $2,500 or less that has beenrefused admission into the United States.
Since there is no requirement that the FDA test the authenticity of seized medicines, we shall witness the spectacle of a governmental agency (the FDA) specifically designed to protect and promote the health and well-being of Americans instead destroying legitimate medicines at a time when millions of citizens are unable to enjoy the health benefits of access to a regimen of prescription medicines because of their high cost.
I respectfully urge you to order a delay in the implementation of Section 708—a move that is gaining support among Congress as it realizes the Section actually is contrary towhat should be the goals of the FDA.I am including a copy of the Section 708 Rule Promulgation submission from TodaysSeniorsNetwork.com and RxforAmerican Health blog as background for your review and consideration.
The publisher of websites about aging and prescription medicine issues has sent a letter to Sylvia Mathews Burwell, recently approved as Secretary of Health and Human Services (HHS) alerting her that unlessshe takes action, Americans may witness the spectacle of a governmental agency (the FDA) specifically designed to protect and promote the health and well-being of Americans destroying personally imported legitimate brand-name medicines at a time when millions of citizens are unable to enjoy the health benefits of access to a regimen of prescription medicines because of their high cost.
Daniel Hines,Publisher of www.TodaysSeniorsNetwork.com and http://RxforAmericanHealth.blogpot.com, said he sent the letter in response to the rules promulgation process of the FDA for Section 708 of the Food and Drug Administration Safety and Innovation Act (FDASIA) which would allow the destruction of a drug valued at $2,500 or less that has been refused admission into the United States.
“Since there is no requirement that the FDA test the authenticity of seized medicines, we can be certain that authentic, safe affordable prescription brand-name medicines personally imported by U.S. citizens from licensed, registered pharmacies inTier One Countries, whose standards of safety and efficacy meet of exceed those of the U.S.,being destroyed merely because of a difference in labels,” Hines notes.
“This has been a goal of Pharma and its allied front groups for more than 15 years during which time the continued predatory pricing practices of Pharma have made the U.S. into a safe haven for the highest prescription drug prices in the world.
Call to Action: Alert your Congressman and Senator to the risks of Section 708 rules to allow the seizure and destruction of safe, affordable, brand-name prescription medicines, and why it could affect Americans' Health by disrupting a lifeline to vital medicines—all to ensure profits for the Pharmaceutical Industry!
The FoodandDrug Administration (FDA ) is proposing a regulation—Section 708—to implement its authority to destroy a drugvalued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation) thathas beenrefused admission intothe United States under the Federal Food,Drug, andCosmetic Act.
·The FDA claims the proposed rule would provide the owner or consignee of a drugthathas beenrefused admission intothe United States with (1) written notice thatFDA intends to destroy the drugand(2) notice and offer an opportunity to present testimony to the Agency beforethe drugis destroyed.
·The FDA and the Pharmaceutical Industry claim that this act is designed to deter illegal, counterfeit prescription medicines into the U.S.
·Actually, the purpose is to cripple and destroy the right of Americans to engage in the personal importation of safe, affordable brand-name prescription medicines from licensed, registered pharmacies from Tier One pharmacies outside the U.S.—countries whose standards of safety and efficacy meet or exceed those of the U.S. FDA.
·This has been a goal of Pharma and its allied front groups for more than 15 years during which time the continued predatory pricing practices of Pharma have made the U.S. into a safe haven for the highest prescription drug prices in the world.
·As a result, millions of Americans have exercised their right to make medical decisions and turned to sources outside the U.S. to provide their lifeline of vital prescription medicines.
·Section 708 is a flawed approach to guarantee product safety of prescription medicines.
·The FDA says it estimates that there would be slightly more than 12,000 destructions of medicines each year, which it describes as a ‘net social benefit’ of between $228,000 and $616,000, making one wonder how the benefit was created and what value the FDA places on its claims of saving American lives.
·Significantly, the FDA notes that the seizures will “benefit firms through increases in sales, brand value, andinvestment in research anddevelopment if the destroyed drugis a counterfeit or an otherwise falsified version of an approved drug” meaning the Pharmaceutical industry which already enjoys outrageous profitability at the expense of the American public will cement its grip on the U.S. as a 'Safe Haven' for the highest drug prices in the world.
It’s time to demand Congress act to protect Americans’ Health,
not Pharma Profits!
you imagine living in a country where people die, not because treatment isn't
available, but because they can't afford the high price of medicine?
Unfortunately, that alarming future America may be imminent. That's why we're
writing to ask for your help. As
you may know from our previous communications, the
FDA is moving forward with a plan to seize and destroy personally imported
medicine. In response, we’re mobilizing our supporters: please
contact Sylvia Burwell, Secretary of Health & Human Services, to express
your opposition. The
proposed FDA rules regarding Section 708 of the FDA Safety and Innovation Act
would give government officials the authority to destroy any imported drug
valued at $2,500 or less. The
rules directly endanger our ability to access affordable medicine from Canada
and other countries. The
public comment period regarding the proposed rules ends July 7. Before then, we
must make as much noise as possible around this issue. We need to stop the destruction of
safe and affordable medicine! And for that to happen, we need people to stand
up and speak out! For
the sake of public health, for people like Sharon in Maryland, please email
Secretary Burwell today about this issue today. Tell her your story. Make
her understand that cutting off access to safe and affordable imported medicine
will harm you and/or your loved ones. Sincerely, Lee
RxRights Lead Organizer
Since the late 1990s, Americans have sought relief from
paying the highest prescription medicine prices in the world by turning first
to Canadian pharmacies and later to licensed registered pharmacies in other
countries to provide them access to safe, affordable prescription medicines.
Immediately Pharma recognized the threat to its ability to
continue to reap extraordinary profits by charging prices for its products that
were as much as 60 to 80 percent higher than the same medicines Americans were
able to procure primarily via the Internet and other sources.
An identification arose in the public’s mind of the issue
primarily based upon a Canadian Internet pharmacy relationship, although other
business models quickly arose to meet the requirement of groups and
organizations acting on behalf of their members and associates to provide them
with similar access, and for years, Americans living close to the Canadian
border had traveled into Canada to purchase their medicines.
Over the past 15 years or so, Pharma has developed a series
of attacks against personal importation that have been characterized by a
singular approach to a particular issue at a given time.
Some example include:
oChallenges to the safety and veracity of internet-based
oChallenges to the safety and efficacy of even
brand-name prescriptions from Tier One countries and produced by Pharma
manufacturers themselves by acting in collusion with the FDA and other U.S. governmental
agencies to seize those very medicines manufactured by the Pharma members
oAttacks upon other business models similar to
what would be described in the US as PBM-like services, a reflection of the
growing recognition by American businesses and organization of the savings made
possible by personal importation;
oEstablishing a number of front groups staffed by
highly paid staff and/or consultants;
oAttempts to co-opt the premise of intellectual
property by seeking to control copyrights beyond their intended purpose
(SOPA,PIPA), and to seek establishment of rules that would extend into other
elements of our society such as free speech, the role of the Internet, and
challenges to the proven safe record of personal importation ;
oContinuing seizures of valid prescriptions
imported into the US, and even one failed effort to force patient/clients to
cede their 5th Amendment rights against self-incrimination (the 2007
oAlliances with other groups such as Pharmacy
Boards, State Attorneys General, etc. to engage in actions to portray personal
importation as aiding the rise of bogus pharmacies producing and dispensing counterfeit
and unsafe medicines, and, in so doing, identifying legitimate and safe
pharmacies from outside the US as not only illegally engaged in dispensing
medicines, that cannot be verified for safety and efficacy.
As noted, virtually all of these and other efforts have been
virtually singular in nature, arising independently with no coordination with
one or more of the other activities.
As a result, even though proponents of personal importation
have been outnumbered, lacking the extensive funding and the Congressional
contacts of Pharma and its allies, we have successful turned back Pharma
efforts in each of these areas.
That has changed.
The Perfect Storm Examined
Simply put, Pharma and its allies have altered their
strategy to launch an all-out push to attack the vulnerabilities.
Each of the actions, taken independently would require
immediate and serious attention and implementation of a strategy to protect
personal importation, but cumulatively, Pharma, with its vast financial and
lobbying resources, believe the actions have the potential to overwhelm the
supporters of personal importation and deny Americans access to safe, affordable
It is moving on many fronts:
It seeks credibility by establishing ‘legal’ authorization
to (a) define seized prescription medicines as counterfeit because they are
‘misbranded’, deemed potentially harmful to American health or are ‘unapproved’
by a quasi-governmental authority granted the private National Association of
Boards of Pharmacy (NABP) through a strategy that would allow it to have
control over the .PHARMACY domain name, which would give the NABP the
quasi-governmental authority to determine the legitimacy of pharmacies around
the world by determining who would have the right to use the .PHARMACY
Added to this are the continuing, and stepped-up efforts, to
portray personally imported medicines as potentially bogus by lumping them with
easily identifiable ‘pharmacies’ and counterfeit medicines by actions such as
that of the Attorneys General of 20 states to put pressure on services such as
Google to take steps to further restrict search services of ‘bogus’ pharmacies,
which will almost certainly have a fallout for legitimate services.
A quick look at the list of actions that might be
implemented in the remaining months of 2014 illustrates the breadth of the
oSection 708 Rules promulgation giving FDA
enforcement and prosecutorial authority for prescription medicine seizures and
destruction of those medicines, coupled with letters from FDA seemingly without any direction from FDA as it delays announcement of rules promulgation and opportunity for 'stakeholder' statements. Significantly, three separate letters are radical departures from previous letters, one going so far as to mistakenly state that Congress forbids personal importation. In the same letter, to a registered nurse who has purchased her medicines via personal importation for several years, the letter picks up bits of previous letters about the inability to determine a seized drug's ingredients.
oState Attorneys General action with Google to
restrict ‘bogus’ pharmacies’ listings;
oTroubling indications of a ‘pre-Blitz’ seizure
action reference letter by FDA that would result in untold numbers of Americans being denied
access to the fiscal and health lifeline of safe, affordable personally
imported prescription medicines;
oNABP push for ownership of ICANN domain name
oComplaint by CEO of Maine Pharmacy Association
designed to claim Achilles Maine Personal Importation Law was not followed by Canadian Internet Pharmacies (action taken
in November 2013, just now coming to light);
oContinued ‘delays’ in Maine Court Decision on
Pharma, Maine Board of Pharmacy law suit on Maine Personal Importation Law passed last year by the Maine
Legislature allowing Maine citizens to purchase personally imported
prescription medicines from the United Kingdom, Australia and New Zealand;
oRevised FDA letter, shortened, no mention of
90-day supply provision found in previous letters;
oAn attitude inside the Beltway by elected
Senators and Representatives who are beneficiaries of huge donations from Pharma
interests that is described as a ‘By Invitation Only’ attitude. The BIO-approach limits the opportunity for
advocates of personal importation to testify before Congressional hearings on
issues that affect the role of personal importation while including only Pharma
oTrans-Pacific Trade Talks being held in secret,
apparently language being dictated in large part by Pharma, an attempt to gain
intellectual property rights denied in unsuccessful PIPA, SOPA strategy through
likely ‘fast track’ vote. Reportedly, opposition is growing to the Pact, most
notably in Australia.
The conclusion is that whereas previous Pharma efforts had
been characterized as admittedly potentially harmful, they were ‘individual’ in
nature and lacked what can be determined in the present circumstance to be
The current Pharma effort on a number of fronts reflects a
comprehensive, coordinated strategy that by its breadth threatens the health
and fiscal interests of the American patient/client for who personal importation
has provided a lifeline to vital medicines. The result Pharma seeks is the
removal of the ability of Americans to engage in personal importation of their prescription
medicines, resulting in a barren landscape which will allow it (Pharma) to act
virtually unchecked in its pricing practices, free of the competitive pressure offered
by personal importation.
Pharma has attempted to claim that access to prescription
drugs is not the issue it once was because of claimed savings in medical
expenses and wide-spread availability of prescription medicines.
The fact is
that medical costs are increasing, as are the costs of Generic medicines,
indicating that Pharma will have a longer-term strategy to gain control
of Generics, thus creating a barren landscape in which Americans continue to
pay not only the highest prices in the industrialized world, but will increase
the number of Americans not being able to follow a prescribed regimen of taking
This will result in reduced heath and well-being of untold numbers
of Americans, as well as the increased cost of medical care for an aging
population that will be more susceptible to disease, but are not old enough for
programs such as Medicare Part D.
The solution? 2014 is
an election year. All 435 seats of the
House of Representatives are ‘open’, The control of the Senate is a goal of
both political parties.
It is an opportunity for Americans to ‘call out’ candidates
to take a stand against the special interests of Pharma, and to issue their own
‘invitation’ in the form of a ballot on Election Day.