Action Alert: Congressional Action needed to prevent unfair seizures of safe, affordable medicines

As the 112^th Congress concludes its business and we prepare for the launch of the 113^th Congress, it is appropriate to call attention to one of the continuing major drivers of healthcare costs—the fact that Americans pay the highest prices for prescription medicines in the world.

It is these prices that have led millions of Americans to turn to personal importation of safe, affordable medicines from licensed, reputable pharmacies in Tier One Countries that have standards of efficacy and safety that meet or exceed those of the United States.

Many members of Congress have repeatedly recognized the importance of this lifeline to vital medicines for Americans by its support of personal importation.  Unfortunately, even when legislation to facilitate personal importation was passed,  Pharma-backed groups of Senators and Representatives thwarted the will of Congress and the American public by the addition of ‘poison pill’ amendments requiring ‘certification’ of each and every imported medicine by the Secretary of Health and Human Services (HHS).

In 2012, Pharma stepped up its activities to curtail the right and ability of Americans to engage in personal importation of their medicines with such legislation as the Protect Intellectual Property Act (PIPA) and the Stop Online Piracy Act (SOPA) , both of which would have given Pharma intellectual property rights that would have branded all imports as ‘counterfeit—ironically, including some of the very same medicines manufactured by Pharma members outside the United States and sold in this country.  

Fortunately, these bills were turned aside , the SOPA bill being particularly significant because it actually led to an Internet ‘blackout,’ a recognition of the onerous provisions of the legislation that would infringe upon a number of American rights.

However, with the passage of the PDUFA legislation—considered a ‘must pass’ piece of legislation to allow the Food and Drug Administration (FDA) to conduct its operations, Pharma again saw an opportunity—Section 708 which unfairly and inaccurately portrays personal importation of medicines from reputable pharmacies as being one and the same with the many bogus pharmacies selling unsafe, counterfeit medicines. A summary of our concerns follows:

a.     In 2006, a bi-partisan effort stopped Customs from seizing vital medicines personally imported by Seniors and others.   Seniors personally importing their medicines had been coerced to sign letters acknowledging their guilt in violating US law, and agreeing that the letter could be used against them in criminal prosecution if they (the Seniors) continued to practice personal importation. Congress found this unacceptable.

b.    We fear there may be some confusion about the actions taken in 2006 to block arbitrary seizures in response to such an abuse of power by Customs and the FDA.  It has come to our attention that there are those supporters of personal importation in Congress who seem to believe that the previous legislation will prevent such arbitrary seizures.  To them, we voice our gratitude for their past support.  However, we must caution that they do not confuse actions taken in 2006 as being binding upon Section 708. 

c.     Section 708 is different. It allows the Secretaries of HHS and Homeland Security to arbitrarily make seizures of medicines valued at $2500 or less if they are deemed to be potentially dangerous to Americans’ health. Unfortunately, this highly commendable goal has been co-opted by Pharma to be likely construed to extend to seizures of legitimate, safe medications.

d.    While the House version of PDUFA did not include any process for due process review, the Senate Leadership was able to get such a provision in the final bill. The following describes our understanding of the provisions:

                                          i.    From the viewpoint of personal importation the structure of the review is based upon an individual initiating a request for a review within 30 days.

                                         ii.    If there is no appeal, the seized medicines are subject to destruction.

                                        iii.    If there is an appeal, and it is not upheld, the individual making the appeal is liable for any costs incurred by the Government during the appeal process.

e.     The authority to make seizures is granted to a wide number of individual Customs agents.

f.     The reasons for seizures include, but are not limited to : Safety, unregistered medicine, new non-approved medicine lacking FDA review/approval (this would immediately make all personally imported medicines subject to seizure since they are approved by the regulatory agency of the country of origin), misbranding (this could include medicines identical to those sold in the US being subject to seizure because of labeling requirements of the country of origin.)

II.             It is our belief that the intent of the legislation as written is evident, creating an authority to grant seizure powers not only of bogus , dangerous and counterfeit drugs, but to expand the scope to seize vital medicines personally imported from sources outside the United States that have a proven record of safety and efficacy.

III.            When the bill was being considered, we made contact with staff on the Senate Health Committee, and were told by Majority Staff that this was not the ‘intent’ of the bill, and that Senate Majority leadership, notably Senator Harkin, was committed to the concept of personal importation of vital medicines, seeking assurances from the FDA that personally imported medicines were not the ‘target’ of the Section.

a.     Significantly, however, when asked further, Staff said that the assurances given to the Senator by FDA were adequate. We fear this might be the impression given to Congressional supporters

b.    Our review of Section 708 has not given us any reason to believe that such good will or intent without being addressed specifically in the legislative language, will prevent unwarranted seizures from occurring, or that individuals—especially seniors—will be able to navigate the complexities of the appeals process and face the risk of the potential costs of an appeal.

In summary, we believe that (a) Section 708 is written in such a manner as to enable arbitrary seizures of legitimate, safe, affordable , and vital medicines that provide a life-line to untold numbers of Americans (b) that even with the stated intent of supporters of personal importation that such seizures will not occur, without specific language excluding such seizures, and that the section , as written, leaves no room for interpretation to the contrary (c) our understanding of the provision is that there is not such exception in the bill.

The result will be that untold numbers of Americans will be forced to either pay higher costs for the very same medicines denied by the seizures, or more tragically imperil their health and well-being by not purchasing vital medicines.  The consequences will be tragic.

That is why we call upon Congress to be alert to what will admittedly be unintended consequences of actions that, on the surface, appear to have merit, but really are nothing more than yet another effort by Pharma-driven forces to solidify the United States as a safe haven for the highest prescription medicine prices in the world, and a major driver of the continuing rise in healthcare costs.

Thank you for your consideration of this letter.

Sincerely,

Daniel Hines

Daniel Hines

Publisher

www.TodaysSeniorsNetwork.com

TodaysSeniorsNetwork is comprised of www.TodaysSeniorsNetwork.com, a leading informational website for the challenges and opportunities of dealing with issues facing an Aging America attracting more than two million visitors annually across the nation, http://RxforAmericanHealth.blogspot.com, www.BoomersNewsOnline.com, and www.RxforAmericanHealth.com .

53 Oak Hill Drive, Ellisville, Missouri, 63021

Phone: 636.399.2849  Fax:  636.386.5904  e-mail: TodaysSeniorsNet@sbcglobal.net

Publisher of leading informational website for Seniors urges FDA to extend its recognition of the importance of ‘reciprocity’ in prescription drug manufacture to personal importation

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.”

Authors Dispute “Innovation Crisis” Among Pharmaceutical Companies

Publisher's Note: One of the claims of the Pharmaceutical Industry in its attempts to deter the rights of Americans to have access to safe, affordable brand-name prescription medicines from pharmacies in Tier One Countries is that personal importation would damage the ability of Pharma to engage in the Research and Development of new, innovative prescription medicines.  The following article from the British Medical Journal shows the fallacy of that stance.

Newswise —– A newly published article in the British Medical Journal disputes the widely held belief that profits at large pharmaceutical companies will plummet as the companies face a “patent cliff” when their exclusive rights expire on several blockbuster drugs. Co-authors Donald Light, PhD, of the University of Medicine and Dentistry of New Jersey-School of Osteopathic Medicine, and Dr. Joel Lexchin of the University of York (Toronto) argue that a “hidden business model” provides major pharmaceutical companies with a solid cushion of steady profits from patent-protected minor variations to their existing drugs.

“Most research and development at large pharmaceutical companies is directed at developing clinically minor drugs rather than finding better drugs for unmet needs,” said Light, who is also a Fellow at the Safra Center for Ethics at Harvard University. “Independent assessments indicate that 80 percent of increased costs paid by employers and insurers for pharmaceuticals is wasted on these ‘new’ drugs that can command higher prices under government patent protections even though they provide little or no benefit over existing medications.”

The authors say claims of an “innovation crisis” in the pharmaceutical industry are a myth arising from media reports of a roughly decade-long decline in the discovery of new molecular entities (NMEs). They cite industry studies to support that conclusion. The Food and Drug Administration defines an NME as “an active ingredient that has never before been marketed in the United States in any form.” According to the article by Light and Lexchin, the “crisis” simply represents a return from an unusual spike during the mid-1990s to the long term average of 15 to 25 NMEs per year.

“Companies are, of course, delighted when research breakthroughs occur, but don’t depend on them,” Light explained. “Instead they focus on promoting minor variations, spending 19 times as much on their marketing efforts as they do on basic research to discover new molecules.”

The resultant sales of these “minor” drugs – some of which become market blockbusters – offset the ups and downs of drugs coming off patents, the authors note. They point to the example of Pfizer, which lost market exclusivity for Lipitor and other major sellers in 2011, but still maintained steady revenues and saw net income increase by 21 percent over the previous year.

The University of Medicine and Dentistry of New Jersey (UMDNJ) is New Jersey’s only health sciences university with more than 6,000 students on five campuses attending the state's three medical schools, its only dental school, a graduate school of biomedical sciences, a school of health related professions, a school of nursing and New Jersey’s only school of public health. UMDNJ operates University Hospital, a Level I Trauma Center in Newark, and University Behavioral HealthCare, which provides a continuum of healthcare services with multiple locations throughout the state.

Why 'we get it' about personal importation

 In a news story about the launch of the Center for Safe Internet Pharmacies (CSIP), the lead in Fierce Pharma Manufacturing, a well-respected news email about the pharmaceutical industry, noted that  “An organization set up lastyear by some of the largest Internet and credit card companies to fight the  scourge of illegal pharmacies selling counterfeit drugs thinks consumers just don't get it.”

Having had more than five decades of experience in communications, and having worked for 12 years on behalf of the right of Americans to engage in personal importation of safe, affordable brand-name medicine from Tier One countries, whose standards of safety and efficacy meet or exceed those of the U.S, I had a sense of, as Yogi Berra used to say , “Dejavu all over again” as I read the statement.

The comment is one that I have heard many times from smug Beltway personalities who believe that Americans outside the Beltway simply lack the intelligence, common-sense and ability to act in a responsible manner to understand what policy-makers don’t, i.e., that personal importation is still the best option available to curtail Pharma (the industry) and PhRMA (its trade association) from making the U.S. even more of a safe haven for the highest prescription medicine prices in the world.

My favorite example was some time ago at a meeting of Former Speaker of the House (and later failed GOP Presidential candidate) Newt Gingrich’s ambitious Center for Health Transformation start-up in Missouri.

After the meeting, I asked his Chief of Staff about the role of personal importation and why the group did not support it as a means of deterring the major price driver of health care costs in the U.S.—rising, unaffordable prescription medicine costs. 

She smiled at me and answered, very condescendingly:  “We don’t want our poor seniors dying like all those pets whose food was contaminated by tainted ingredients from Chinese plants.”

My response: “Do I look like I fell off the turnip truck yesterday?  I asked you a legitimate question about healthcare policy and you talk to me about dog food—which, by the way, many seniors have eaten because they couldn’t afford their medicines!”

She walked away, never to be seen again (at least by me).

But, her spirit, like Marley's ghost , still wanders the earth.  The opening paragraph from the Fierce Pharma Manufacturing article was its latest incarnation.

I must point out that I am not critical of FPM since I am sure its comment merely reflected the fallacy of Pharma’s claims about the ability of Americans to act in a responsible manner when it comes to distinguishing clearly bogus sources of medicines from legitimate sources.

And, despite what the source of the comment about Americans “not getting it,”  I want to assure CISP that, yes we do:

• ·         We get it that prescription drug prices in the U.S. are the highest in the world, as much as 60 percent more than the same drug in Tier One Countries;

• ·         We get it that the medicines that PhRMA would deny access to are the very samemedicines manufactured in FDA-approved facilities, usually in plants outside the U.S.  and then given a different label to meet U.S. requirements (language, etc.) to be sold at tremendous markups to U.S. citizens;

• ·         We get it that PhRMA has an undue and troubling influence in healthcare policy, to the extent of dictating policy behind closed-doors to even the President of the United States;

• ·         We get it that dozens of members of the House of Representatives and the U.S. Senate receive millions of dollars from the pharmaceutical industry;

• ·         We get it that it was the necessity of untold numbers of Americans not being able to afford their prescription medicines more than 12 years ago that led to bustrips into Canada where suddenly Grandma became a ‘drug smuggler’ bringing back safe, affordable medicines from Canadian pharmacies, a situation that led to the rise of Canadian pharmacies establishing the online pharmacy business;

• ·         We get it that the answer was a flawed Part D Prescription Drug program in which seniors had to pay for insurance, pay high deductibles, and then after receiving their benefit, were forced into the so-called ‘Doughnut Hole’ in which they had to pay again for their medicines PLUS paying for their insurance ‘coverage,’ all thanks to the last-second efforts of Rep. Billy Tauzin (D-LA 3) to insertprovisions favorable to and dictated by PhRMA and its members (His reward?  He resigned from Congress and accepted the role of the head of PhRMA at a salary of $2 million per year.  Now, what do you think he ever did that made him worth that much to the industry?);

• ·         We get it the Pharmaceutical industry is considered by many the most corrupt inthe U.S.

• ·         We get it that as the industry claims to tout safety, many of its leading members continue to be found guilty of unsafe practices.  The most recent notable example is the travails of GlaxoSmithKline (GSK), which settled a Department of Justice action for  $3 BILLION!  (For the sake of transparency, at the above referred-to meeting of Newt Gingrich, I met with a director of state legislation for GSK who expressed an interest in outreach to seniors and establishing communications on the role of personal importation. We exchanged several emails regarding how that might be accomplished, since I believed that expanded personal importation could actually be of benefit to Americans by lowering prices, with the expanded use of affordable medicines by Americans actually being beneficial to the industry itself.  Needless to say, the conversations went nowhere, because, as my contact noted, ‘I had said some pretty rough things’ about industry practices. Based on the recent DOJ experience, perhaps GSK should have listened to me.)

• ·         We get it that the FDA has been charged by many as being instrumental in the shortage of vital medicines that has led to opening new opportunities for gaps in the worldwide supply chain to be exploited by counterfeiters.  (Ironically, the latest example of this, the entry of counterfeit Avastin, a cancer-treating drug, into the American supply, actually was detected and uncovered.  The leakage did not involve an internet pharmacy, although the wholesale operations of Canada Drugs, a leading Canadian internet pharmacy, were involved, and opponents have attempted to seize the situation to disparage the ability to guarantee the safety and efficacy of personally imported medicines.)

• ·         Weget it that safety is of primary importance, and that geography does notguarantee safety for those such as the Kansas City pharmacist, who was licensedby his state Board of Pharmacy, diluted vital cancer medicines for years beforebeing discovered in 2001;

• ·         Weget it that  Pharma’s hands are not ‘clean’in such matters.  In 2011, the offending pharmacist had a $2.2 billion judgment against him, and, significantly, EliLilly and Bristol-Myers Squibb, settled charges that they were negligent out of court;

• ·         We get it that the FDA has for years worked to scare Americans either by the use of the intimidation of seniors such as was done in the infamous use of Customs to seize medicines and then demand that the elderly sign letters admitting totheir ‘guilt’ and pledging to not engage in personal importation again, and now, with the launch of CSIP, a ‘public service announcement’ in which a youthful caregiver is concerned that prescription medicines ordered on the internet might kill Grandfather unless they are from a pharmacy ‘approved’ by CSIP;

• ·         We get it that responsible legislators from both political parties including but notlimited to Senators McCain, Vitter and Snowe on the GOP side and Dorgan, Nelson of Florida, Brown of Ohio, Franken and Klobuchar of Minnesota, and even that lovable old Socialist Bernie Sanders have long supported personal importation legislation,only to have it denied by secret deals of the Obama administration with PhRMA,or Poison Pill ‘certification’ requirements.

• ·         We get it that in 2008, then-candidate Obama pledged that he would support personal importation, and then as President Obama, switched his position to prevent PhRMA from mounting a Harry and Louis-type campaign of the type that killed HillaryCare and that the President feared would deal a death-blow to ObamaCare;

• ·         We get it that U.S. prescription medicine prices continue to increase at a rate greater than inflation and are a major driver of the health-care cost crisisthe country faces;

• ·         We get it that Pharma supporters in Congress have tried repeatedly to co-opt legislation regarding intellectual property rights with the insertion of Pharma-driven (and written or directed) sections that would have claimed infringement of copyrights and intellectual property of Pharma, with the unintended consequence of damage to the health and well-being of untold numbers of Americans who wouldlose their access to vital medicines, a factor in the flawed bills that led totheir overwhelming defeat;

• ·         We get it that untold numbers of Americans have safely purchased their medicines viapersonal importation, and their communities and families have benefitted fromtheir enhanced health and well-being;

• ·         We get it that even with a host of governmental programs, millions of Americans are still not able to afford their medicines;

So to our new-found ‘friends’ at CSIP, welcome to the fold.  IF you stick to farrowing out the truly bogus pharmacies, we applaud you.  IF you try to confuse the issue with attacks upon the concept of personal importation, we urge you to be truthful about your real goals.  But don’t think that we don’t get it or that we won't get it..  As I said, we didn’t fall off the turnip truck yesterday.

Missouri Congresswoman displays courage, insight, leadership in comments about onerous Section 805 ‘power grab’ by Pharma, Health Human Services and Homeland Security

 There is legislation in Congress that is considered ‘must pass.’  These are bills of such vital importance that there is virtually total agreement on their importance to protecting the safety of the American public.

That is why it was not surprising that recently first the U.S. Senate , and within a week later the House of Representatives overwhelmingly passed the Prescription Drug UserFee Act (PDUFA), which generates the vast majority of the federal government’s budget for the Food and Drug Administration’s (FDA) reviewing new medications.

This is one of the legitimate and valuable functions of the FDA.  The other is to provide the oversight to ensure a safe food supply forAmericans.

But, Washington being Washington, nothing is as simple as it seems. 

Lobbyists,staffers with a particular political agenda, and special interests of Congressional Representatives  and Senators have too often created a synergy that betrays the very purpose of agencies such asthe FDA by making it a surrogate for implementing policies that benefitthe particular and limited goals of those who would stand to profit, rather than doing what is best for Americans.

This occurs because special interests are able to co-opt the intent of the legislativeprocess by having Congressmen and Senators insert onerous elements in thebills, elements skillfully crafted to seem to be in accordance with the purposeof the legislation.

No lobby is better at this than the Pharmaceutical industry and its trade group PhRMA. 

For many years, we have published blogs detailing the network of the many front groups that PhRMA has created under the guise of ‘protecting’ the safety of prescription medicines sold in the United States, but which are actually meant to make the US a ‘safe haven’ for the highest prescription medicine prices in the world.

For more than 12 years, PhRMA and its members have used their vast army of lobbyists and their seemingly unlimited financial resources to deny the right of Americans to have access to safe,affordable brand-name medicines from licensed, registered pharmacies in Tier One countries, whose standards of safety and oversight meet or exceed those of the US.

They have had some successes, primary by inserting ‘poison pill’ amendments to legislationpassed by the Senate (many times) requiring the Secretary of Health and HumanServices (HHS)  to ‘certify’ the safety of each and every prescription medicine personally imported, effectively killing the legislation.

But, a distinguishing characteristic is that they never seem to give up.  However, even with their vast expenditures, Pharma is not invincible. But, it is persistent, as the following record of creating mischief illustrates:

Over the years, working in collusion with the supportive staff of the FDA, opponents of personally imported medicines have attempted a number of tactics:

• ·         Random and ill-founded seizures of legitimate prescription medicines by Customs Inspectors, extending even to intimidation of the Elderly persons, who were denied their vital medicines by the seizures,  by demanding that they sign letters prepared by Customs in which the Seniors purchasing the medicine  ‘admitted’ to being ‘guilty’ of importing ‘illegal’ medicines.

o   When Congress learned of the practices of Customs, it quickly passed legislationforbidding the seizures and ending the Customs involvement.

• ·         Attemptsto deter personal importation by attempting to lump prescription medicines fromoutside the US as ‘bogus’ and potentially dangerous to the health of Americans.

o   Fortunately, the common sense of the American public has prevailed, and the record is clear regarding the safety and efficacy of imported medicines from reputable sources.  This has been validated by independent studies, as well as Americans demonstrating that they do indeed have the ability to make responsible decisions and the ability to distinguish between legitimate sources for safe, affordable medicines.

o   Ironically, the case can be made that if Pharma were to expend the same amount of energy towards reciprocity with Tier One countries, as it and the FDA have now done regarding inspections of ingredients for the manufacture of pharmaceuticals,  such action could be beneficial in attacking the challenge of bogus pharmacies.

o   In what was a blatant betrayal of Candidate Obama’s pledge of support for personal importation, the Obama Administration engaged in ‘secret’ deal-making with Pharma in which the Administration pledged to drop support for personal importation in return for PhRMA’s pledge not to engage a ‘Harry and Louise’ type campaign (which deterred President Bill Clinton’s Administration in its attempts at healthcare reform) against what the President hoped to be his ‘legacy’ legislative accomplishment. Recently released emails between PhRMA and the White House should be ‘must reading’for anyone with indignation over the influence of powerful lobbying groups.  Ironically, the lack of transparency might be responsible for the many flaws in Obamacare--flaws that could have been avoided if there had been more opportunity for citizen input with open sessions, and which might be responsible for the legislation's constitutionality being decided by the US Supreme Court.  The outcome could affect a number of situations, including, if it is overturned, the possibility of PhRMA declaring that all deals are void.

o    http://rxforamericanhealth.blogspot.com/2011/11/stop-online-piracy-act-endangers-health.html  in which it attempted to use language that would have given legislative sanction to Pharma’s battle against personal importation.  The law of unintendedconsequences was exemplified by a ‘blackout’ and disruption of the Internet, the coming together of seniors’ groups with technical interest groups, resulting in more than 100,000 letters and emails sent by America’s elderly to Congress and the Senate.

However, the thrill of victory was short-lived as Pharma turned its attention to PDUFA, which because of its ‘must-pass’ quality, has problematic language in both the Senate and House bill.

The Senate bill contains a provision from Senator Tom Harkin (D-IA) that might be open to interpretation of the FDA that pharmacies in other countries involved in personal importation must register with the FDA.  

In conversations with the Senator's office and designees, we have been assured that the Senator continues to 'support' personal importation, and had worked with the FDA to assure that no action is taken against personal importation, but significantly when the contact with the Majority Office, the staff member said that the Conference Committee will not add language similar to that of previous bills to specifically exempt personally imported prescription medicines, because there is 'no intent' that pharmacies are included in the registration requirement.  We were told that the language is intended for ingredients manufacturers in other countries. 

We have, however, been told that the presumed members of the Conference Committee are reportedly meeting informally and in secret, causing us to wonder if they will ever learn,even after hobbling together the Rube Goldberg healthcare proposal now being considered by the Supreme Court.  

But, it in the House of Representatives when the most onerous language can be found.  Section 805 would authorize the Secretaries of HHS and Homeland Security to seize and immediately destroy and medicine that they deem to be potentially harmful to Americans' health OR (my emphasis) with a value of less than $2000. 

That is why it is gratifying to see the courage of Rep. Joanne Emerson (R-MO 8)in making the record on what advocates believe is the latest subterfuge of PhRMA to attempt to co-opt legislation for its own purposes and to open a new front on its continuing battle against personal importation--this time with the sanction of the legislative process.

Rep. Emerson's statement follows:

"MR. SPEAKER, I want to express my support for the reauthorization of the Food and Drug Administration (FDA) under consideration today.  The FDA provides essential safeguards for patients in America and around the world, while making possible new treatments and therapies for diseases and conditions which affect millions.  This bill supports greater speed of generic medications to market and assures much needed drugs to treat cancer will get to the patients who need them.

"However, one provision (Section 805) in this legislation causes me special concern.  The section includes the new authority for the Secretary of Health and Human Services to consult with the Department of Homeland Security to cause the destruction of any drug "that has reasonable probability of causing serious adverse health consequences or death. or that is valued at an amount that is $2,000 or less."  This section poses a serious concern to hundreds of thousands of Americans who receive their drugs by mail from licensed and regulated pharmacies in Canada and other foreign countries.

"For these patients, these American consumers, there is often only one choice beyond a Canadian pharmacy, and that is to not purchase the medicines they need at all.

Patients expecting receipt of legitimate prescriptions, written by their doctor and filled by a licensed pharmacy in Canada, could have their shipment of medication destroyed without receiving any notification either before or after the federal government takes that action.  A bus full of senior citizens which crosses the border into Canada to visit a pharmacy where they can fill their prescriptions for one-third the price of the same medications in Canada could have their pill bottles seized at the border, their meager budget for their monthly health care expenses already exhausted.  This is not good policy, nor is it what Americans expect from a free market.

"This language threatens a critical, cost-effective supply of medications and pharmaceuticals.  These drugs are exactly the same as their counterparts sold in America.  I urge further discussion of this critical issue in conference and a full examination of the consequences of passing this provision into law."

With her statement, Rep. Emerson, a long-time supporter of personal importation and the co-founder of the Affordable Medicine Caucus with Rep. Peter Welch (D-VT-At Large) has put Pharma on notice to not attempt to misinterpret the 'intent' of Section 805,  and she has made the record on behalf of and support for personal importation.

Rep. Emerson's example should be an example for other legislators.

Attempts by PhRMA to co-opt legislation in the same manner that it dealt with a White House so desperate to enact a legacy bill that it violated the positions and principles that the American public embraced in Candidate Obama in 2008, must be opposed by the American public, who hopefully  will rally in opposition to continued efforts at power grabs by unelected bureaucrats claiming the right to interpret implementation of legislation that could drastically affect the personal health and  well-being of untold numbers of Americans.

Let's hope their legislators heed the sentiments of American citizens and not those of PhRMA.  

.

Prescription drug personal importation bill fails in Senate. 'Do no Harm' to personal importation should be goal of policy-makers

Watching the ‘debate’ regarding the amendment by Senator John McCain (R-AZ) in support of his amendment to the Food and Drug Administration funding bill to establish astructure for personal importation of prescription medicines by individuals,one had to have a feeling of de javu.

There were so many  familiar faces.  Senator  McCain  showing his irritation and frustration at the continued success of Pharma in derailing any importation legislation…Senator Charles Grassley (R-IA) once again exhibiting the Midwestern Common Sense that has made him a favorite with Iowa voters…Senator Olympia Snowe (R-ME) in a last hurrah before retiring after this term, showing the passion and leadership that has made her name synonymous with personal importation through the bills that bore her and former Senator Byron Dorgan’s(D-ND) names. 

She even used the Lipitor example of the former Senator Dorgan and one could only wonder if Senator Dorgan, who retired from the Senate after his last valiant effort topass legislation favorable to personal importation—a failure which he laid at the doorstep of the White House, accusing the Obama Administration ofdeal-making with Pharma--would appear on the Floor and lend her his favorite prop, a bottle of Lipitor, the most profitable medicine ever developed. 

At the same time, one had to wonder why Senator Snowe used the Lipitor example since the drug no longer has its patent protection, and a flood of generics is expected to erode the market Lipitor enjoyed when it had such protection.

There were many of the same Pharma supporters of past debates, who pooh-poohed Senator McCain’s charges about Pharma influence, which is so obvious that to deny it is and of itself a self-proving action. 

But while the amendment went down in flames with 43 yeas, 54 nays (60 votes needed toadoption), there were other reasons that it failed, none of which has anything to do with the merits, benefits and record of personal importation.

Not the least of these was an old problem continues to be troublesome for  importation legislation and is an indication that since there likely will be no form of legislation passed, the goal should be to protect the right to personal importation.  Although the amendment has passed in the Senate many times, it has always had a challenge in even being called up for a vote.

Former Senate Majority Leader Bill Frist (R-TN), who has since returned to private medical practice, reneged on his commitment to bring the proposal up for a vote during the administration of George W. Bush.  This led to a running discussion throughout  that session of Congress and succeeding sessions of what strategy would be employed to identify a ‘vehicle’ to which to attach the legislation.

The problems continued with the election of President Barrack Obama. 

Supporters all believed Candidate Obama to be a proponent of personal importation, until an aide, Dora Hughes, said in September 2008 that Candidate Obama was not as strong a supporter of personal importation as had been presumed. 

Still, while at a hearing in St. Louis by Senator Claire McCaskill, when I asked the Senator   about the Obama position, she assured me that it would be the first bill he signed into law.

Alas, we were soon to discover when President Obama made a closed-door, back-room deal with Pharma to not support personal importation in return for a Pharma guarantee of not doing a ‘Harry and Louise-type attack’  upon the President’s healthcare proposal, that,alas, Ms. Hughes’  insights were better than Senator McCaskill’s.  And,  as noted earlier, Senator Dorgan  bemoaned the lack of leadership from the Obama Administration when his final effort also fell short of the 60-vote threshold,citing the deals made by Pharma with the Administration.

The simple truth:  The President early on determined that Healthcare Legislation was to be his legacy.  The economy and joblessness were set aside, as was prescription medicine importation .

Part of the closed-door negotiations including blocking personal importation was to strike a deal that supposedly was to reduce the costs of medicines for Seniors in the Doughnut Hole by $80 billion (but which because of the delay of enacting the cuts, and prescription price increases, has been one of the best investments Pharma ever made—even more lucrative than the multi-million investment in former Representative Billy Tauzin (D-LA) who engineered the passage of Part D,  and then resigned his post to immediatelybecame head of PhRMA, the industry’s trade association).

If anyone wonders why Senator McCain was so upset during the most recent claims by Pharma's Senators that healthcare policy is not/has not/and will not be influenced by Pharma—which Senator McCain described as the very type of thing that has eroded public confidence in Congres-- may I suggest it was not ‘anger’ or temper, it was righteous indignation.

Still, the amendment he offered and 41 other Senators supported was defined by situations that reflected the same, albeit , valid arguments made since Seniors were the first Americans to turn to personal importation of prescription medicines at the turn of the Century 12 years ago via bus trips to Canada to order their medicines at tremendous savings of as much as 60 percent.

Their actions were to give rise to a vigorous new industry—the establishment of certified, licensed, and registered pharmacies dispensing medications via the Internet, thereby allowing more than just the Americans located on the Northern US Border to have access to safe, affordable brand-name medicines at tremendous savings.

It also spurred many local groups, governments and others individual Americans to realize that they could attain fiscal relief through personal importation , all the while providing the  health benefits of  access to safe, affordable brand-name medicines.

Lower costs…improved health…fiscal savings…safety…a competitive alternative to the highest prescription medicine prices in the world…those are the drivers that make personal importation still the most viable option available to lowering US prescription medicine prices.

Personal importation validates that Americans can use their Common Sense in exercising their right and ability to make responsible healthcare decisions.  That native Common Sense is absent from the US Congress that has failed in developing solutions to the challenge of high prescription medicine prices that before the widespread use of personal importation forced millionsof citizens to do either without their vital medicines or without other  life-supporting services such as food andshelter.

And therein, I submit, lies the root of the ‘solution’ to the challenge of presentation and support of any legislation that might be presented in the future in support of personal importation—namely, illustrating how personal importation reflects the inherent Common Sense of the American people, similar to Rep. Ron Paul's (R-TX) proposal (HR 147) to basically, 'just do it,' which we have supported for sometime.

The McCain amendment was self-defeating with its emphasis upon restrictions of sourcing that limited personal importation to only medicines from Canadian internet-based pharmacies because the language had ambiguities that would have made the amendment ineffective.  Example: the medicines would by my reading have to be dispensed specifically by a Canadian Internet pharmacy,  restricting the ability to have medicines dispensed from licensed, registered pharmacies in other countries whose standards of oversight and efficacy meet or exceed  those of pharmacies in Canada or the U.S.

The legislation also called for the Secretary of Health and Human Services to ‘certify’ the involved pharmacies, although they have been approved by the appropriate provincial licensing authority in Canada.  In a touch of irony, previous forms of personal importation legislation that have passed the Senate have been turned aside by opponents of personal importation by the introduction of ‘poison pill’ amendments requiring ‘certification’ by the Secretary of Health and Human Services that any imported medicine is safe.

 It’s a ridiculous position, one that was first introduced at the same time that Ford F150’s were crashing and burning, causing me to suggest to then-Senator James Talent’s (R-MO) staff, that the ‘certification’ of the safety of ALL vehicles, tires, engines, etc.,  should be demanded of  the Secretary of Transportation, requiring that he or she ‘certify’ that there would be no recalls nor safety problems with the Ford vehicles at that time, or other situations that could affect the safety of a vehicle.

What will be next? 

Perhaps the Online Pharmacy Safety Act, introduced by Senator Diane Feinstein (D-CA) and Senator Jeff Sessions (R-AL)  that would empower the Secretary of HHS to utilize the VIPPS Certification Program of the NationalAssociation of Pharmacy Boards to ‘certify’ online pharmacies in the US, an authority it denies certification services such as PharmacyChecker.com andPharmacy Accreditation Services, designed specifically to provide oversight services for Internet pharmacies.

Senator Snowe described the McCain Amendment as a ‘first step.’  Actually, the first step was taken years ago by millions of Seniors  , followed by untold numbers of other Americans for whom personal importation of brand-name medicines has provided a lifeline to vital medicines that have contributed to their health, finances, and well-being.

By continuing the comparisons of price differences alone, without a greater emphasis upon the beneficial contribution and proven record of personal importation to providing fair and equitable pricing for vital medicines, and improved health, the proponents of personal importation, of whom I am one, continue to allow opponents to trot out the same old tired saws about rogue pharmacies, the claimed 'dangers ' of the Internet from even legitimate safe pharmacies, and the claimed negative impact upon R&D of new medicines.

Even after  Pharma’s stunning defeat in the Stop Online Pharmacy Act,  the latest vote is indicative that Senator McCain’s lament about the influence of Pharma inside the Beltway is ‘on spot.'

It is time for proponents of personal importation to shape their message and quit dribbling the basketball at Pharma’s 50-yard line and come forth with the proven merits and benefits already made possible by personal importation.   By developing such a message of what the past and future benefits will be, not merely for the purpose of passing legislation but to ensure Congress acts to block Pharma's continuing effort to scare the American people in such a way as to keep them using their Common Sense to continue exercising their right--and capability--to make responsible healthcare decisions, and to distinguish facts from Pharma-driven-fiction--the continued beneficial contribution of personal importation shall be ensured.