Nonprofit working to block drug imports has ties to pharma lobby

Business, Emily Kopp , Rachel Bluth · Kaiser Health News · Apr 18, 2017

A nonprofit organization that has orchestrated a wide-reaching campaign against foreign drug imports has deep ties to the Pharmaceutical Research and Manufacturers of America, or PhRMA, the powerful lobbying group that includes Eli Lilly, Pfizer and Bayer.

The nonprofit, called the Partnership for Safe Medicines, has recently emerged as a leading voice against Senate bills that would allow drugs to be imported from Canada.

Both the lobbying group and the nonprofit partnership have gone to great lengths to show that drugmakers are not driving what they describe as a grass-roots effort to fight imports, including an expensive advertising blitz and an event last week that featured high-profile former FBI officials and a former Food and Drug Administration commissioner.

However, a Kaiser Health News analysis of groups involved in the partnership shows more than one-third have received PhRMA funding or are local chapters of groups that have received PhRMA funding, according to PhRMA tax disclosures from 2013 to 2015.

Forty-seven of the organizations listed in the ads appear to be advocacy organizations that received no money from PhRMA in those years.

A PhRMA senior vice president, Scott LaGanga, previously led the Partnership for Safe Medicines for 10 years. At PhRMA, LaGanga was responsible for the lobbying group's alliances with patient advocacy groups, and he was simultaneously listed as the executive director of the Partnership for Safe Medicines on each of that group's annual tax filings since 2007, the earliest year for which they are available from ProPublica's Nonprofit Explorer.

LaGanga wrote a 2011 article about the partnership's origins. Published in the Journal of Commercial Biotechnology, it described "public-private partnerships in addressing counterfeit medicines." His PhRMA job was not disclosed in the article.

From 2010 to 2014, the organization hosted a conference called the Partnership for Safe Medicines Interchange. In a video from a 2013 event, LaGanga thanks pharmaceutical companies, most of them PhRMA members, for sponsoring the event.

In February, LaGanga moved to a senior role at PhRMA and stepped down as executive director of the Partnership for Safe Medicines, just as the group's campaign to stop import legislation was revving up.

The partnership's new executive director, Shabbir Safdar, said LaGanga resigned from the group to avoid the appearance of a conflict of interest.

"That's why Scott's not executive director anymore," he said. PhRMA declined to make LaGanga available for an interview.

Considering Legislation

The Senate push to allow Americans to buy pharmaceuticals from Canada comes as more patients balk at filling prescriptions because of soaring drug prices. Prescription medicines purchased in the U.S. can run three times what they cost in Canada, data from the company PharmacyChecker.com show.

In 2016, about 19 million Americans purchased pharmaceuticals illegally from foreign sources through online pharmacies or while traveling, according to a Kaiser Family Foundation poll. Many survey respondents cited pricing disparities as the reason.

A bill cosponsored by Sen. Bernie Sanders (I-Vt.) would provide a mechanism for Canadian drug manufacturers to sell to U.S. consumers and pharmacies. Sanders introduced the bill in February. In January, Sens. John McCain (R-Ariz.) and Amy Klobuchar (D-Minn.) also introduced a bill to allow drug imports from Canada.

In the House, Rep. Elijah Cummings (D-Md.) introduced a similar bill to Sanders', along with 23 other Democrats.

The U.S. drug industry has strongly opposed efforts to open the borders to drug imports, but the PhRMA lobbying group is not mentioned in the nonprofit partnership's recent advertising blitz against the proposed legislation. The nonprofit says its grass-roots effort is supported by 170 members, including professional organizations and trade groups.

The nonprofit describes PhRMA as a dues-paying member with no larger role in shaping the group's activities. Partnership spokeswoman Clare Krusing would not say how much each member contributes. PhRMA spokeswoman Allyson Funk declined to say whether PhRMA funds the partnership.

"PhRMA engages with stakeholders across the health care system to hear their perspectives and priorities," Funk said. "We work with many organizations with which we have both agreements and disagreements on public policy issues, and believe engagement and dialogue are critical."

Campaigning Against Drug Imports

The partnership recently launched its ad campaign, warning against the alleged dangers of legalizing Canadian drug imports. It includes television commercials, promoted search results on Google and a full-page print ad in The Washington Post and The Hill. The group's YouTube page shows recent commercials targeted to viewers in 13 states.

"We don't disclose specific ad figures, but the campaign is in the high six figures," Safdar said.

The commercials ask voters to urge their senators to "oppose dangerous drug importation legislation."

The newspaper ad reads, "Keep the nation's prescription drug supply safe. Urge the Senate to reject drug importation measures." Its headline declares that "170 healthcare advocacy groups oppose drug importation," noting a letter to Congress signed by its members. The ad lists 160 members who signed the letter, and PhRMA's name is not included.

"Having a big membership allows the coalition to present what looks like a unified show of grass-roots support ... but it does raise questions about which members of the coalition are really driving and funding the group's policy-making," said Matthew McCoy, a postdoctoral fellow at the University of Pennsylvania who studies patient advocacy groups.

The list of groups includes at least 64 trade organizations representing the biomedical industry, professional associations representing pharmacists, a private research company and two insurance companies.

One group that signed the letter, the "Citrus Council, National Kidney Foundation of Florida Inc.," represents a single volunteer, according to an email from the group. A spokesman for the National Kidney Foundation of Florida said the volunteer's views contradict the position of the umbrella group, and said the foundation supports "any sort of drug importation that allows our patients to have access to drugs at the best price."

Two of the hepatitis patients' advocacy groups that were listed, the National Association of Hepatitis Task Forces and the California Hepatitis C Task Force, are run by the same person, Bill Remak. Remak said the groups receive small amounts of PhRMA funding.

"I don't enjoy having to take this extreme position of saying we shouldn't import at all, but until we have some oversight regime, some way of protecting consumers, it's a really tough call," he said.

"Current drug importation proposals do not appear to have equal safety and chain-of-custody accountability laid out adequately for patient safety concerns," said William Arnold, president of the Community Access National Network, which is also listed in the ad and is an advocacy and support group for people living with HIV/AIDS or hepatitis in Washington, D.C. His group did not accept money from PhRMA between 2013 to 2015, the Kaiser Health News analysis found.

Concerns About Safety And Price

Last week, the partnership hosted a panel at the National Press Club featuring former FBI director Louis Freeh and former FDA commissioner Dr. Andrew von Eschenbach. The discussion focused on the alleged health and legal dangers of online pharmacies.

"You can talk about lowering prices, but if a drug comes with a high probability of toxicity and death, that comes at a high cost to the patient," von Eschenbach said. "That's what's at issue with drug importation."

Each speaker argued that the bill co-sponsored by Sanders would be harmful to patients. Around the same time that bill was introduced, the partnership also sent emails to member organizations seeking help to stop such a measure.

Speakers at the partnership event claimed importation would lead to a flood of counterfeit medicines laced with arsenic, fentanyl and lead paint.

"These drugs are manufactured in jungles, in tin drums, in basements. ... Those are the sort of sanitary conditions we're talking about here," said George Karavetsos, a former director of the FDA's Office of Criminal Investigations.

Both von Eschenbach and Karavetsos have ties to the pharmaceutical industry. Von Eschenbach left the FDA in 2009 to join Greenleaf Health, which counsels pharmaceutical clients, before starting his own consulting company, and Karavetsos counsels pharmaceutical clients at DLA Piper, a Washington, D.C., law firm.

In an interview, Josh Miller-Lewis, Sanders' deputy director of communications, refuted Karavetsos' arguments. He said Canadian drugmakers can apply for licenses, and all drugs would have to come from FDA-inspected plants.

Politico reported in October that PhRMA is bolstering its war chest by another $100 million per year, suggesting to many industry analysts that drugmakers are gearing up for a ferocious fight.

"I think it's safe to say pharmaceutical corporations are prepared to spend some fraction of their multibillion-dollar profits to fight drug importation and any other policy that might end the plague of overpriced medicine," said Rick Claypool, research director for Public Citizen, a watchdog group critical of the drug industry.

Candidate call for temporary importation of meds proves FDA can and should work to review personally imported brand-name prescriptions from Tier One Countries

ST. LOUIS, MISSOURI, USA, September 7, 2016 /EINPresswire.com/ -- The publisher of RxforAmericanHealth says Hillary Clinton’s plans to lower prescription prices proves that the Food and Drug Administration, Pharma and Pharma supporters have misled the American Public about the ability to ascertain authenticity and safety of personally imported medicines!

Daniel Hines notes that Ms. Clinton’s plan calls for importing medicines when drug prices are ‘threatening’ the health of Americans because the drugs are unaffordable.

“This should be extended to unaffordable ‘maintenance’ brand-name drugs that millions of Americans rely upon as a vital health link,” Hines says.

He suggests that while her plan calls for ‘temporary’ personal importation, she likely would have to use executive orders to implement ‘temporary ’importation because of Congress’ failure to even vote on bills allowing personal importation of brand-name medicines from licensed, registered pharmacies in Tier One Countries.

“Congress should end its seemingly endless delays, investigations, statements, and business as usual,” Hines says.

As to being able to validate the safety and authenticity of imported medicines which the FDA and Pharma have said is not possible, Hines notes that:

• The Clinton stance clearly relies upon medicines from what can only be construed at Tier One Countries with proven standards of safety and efficacy;

• She points out that the FDA has previously allowed such ‘emergency’ importation;

• This illustrates that, contrary to repeated claims of the Food and Drug Administration regarding personal importation that :

o It is possible to monitor and certify the safety, authenticity of brand name medicines ‘imported’ to the U.S.;

o Since such ‘importation’ would have to be implemented quickly to be of benefit indicates that the FDA is capable of validating the sourcing, manufacture, packaging, safety and efficacy of such medicines. It has for years cooperated with foreign sources for ingredients’ oversight, and has certainly worked with regulatory agencies in other countries during previous ‘emergency’ importation;

o The implementation of ‘temporary importation’ is proof of the safety and efficacy of imported medicines as well as their immediate economic benefit, and, their favorable impact upon Americans’ health.

o The lie to claims by Pharma and the FDA that a medicine allowed to be imported from a Tier One Country cannot be validated would be repudiated.

“A medicine that is imported in an ‘emergency’ situation that is safe and authentic does not become fraudulent after the ‘emergency’ is over, Hines says.

“When a medicine—any medicine—is unaffordable, it is unavailable, and that unavailability creates a health crisis for the individual denied access to vital medicines.”

Hines explains that a ‘temporary importation’ would illustrate the contradiction of a policy that raises questions about the ‘legality’ of personal importation, since it clearly shows that the Federal Government is willing to consider importation as a part of a national policy to lower prescription drug costs to protect the health of Americans;

“It is time that that recognition of the potential benefit to fair pricing of medicines and the right to importation should be extended to the millions of Americans who are unable to afford not only their specialty medicines, but their highly important maintenance medicines that have been proven in the Rand study of enrollees in the Affordable Care Act to improve patient health and lower drug spending”

Hines notes that the Clinton plan calls for consumer involvement and representation in an oversight group to monitor and determine when price abuses by Pharma have occurred, one of the key articles of the American Rx Bill of Rights.

He explains however that the key to the effectiveness of such a group will be based on a determination of the members of the ‘consumer’ advocacy segment and how they will be selected.

“The concept is a valid approach, but only if implemented in such a fashion as to include truly representative advocacy groups that represent patients’ rights and needs,” he notes.

He also says that the strong emphasis in the Clinton plan on the role of generics may be misplaced.

“In what is can only be construed as an admission of the failure of reliance upon generics to lower drug costs because of their being co-opted for many of the price increases in the past 18 months, the Clinton place calls for fines and penalties to be assessed against Pharma and generic industry firms that are found to profit from excessive price increases,” Hines says.

He lauds the plan calling for an end to several key elements of Pharma strategies: One is ending pay-to-delay, a tactic to delay the introduction of generics to replace brand-name drugs scheduled to lose patent protection; another is a call for negotiating Medicare Drug prices; The plan would also call for an end to the backlog of generic applications awaiting approval at the FDA; and, in one of the most dramatic recommendations, it calls for an end to direct-to-consumer (DTC) advertising by Pharma, with the money spent on DTC being redirected to Research and Development.

Hines says that Pharma has, because of its extensive lobbying and financial support of candidates at the state and Federal levels, been able to turn aside any effort to erode its ability to engage in a ‘what the traffic will bear’ pricing approach.

“ If any strategy—be it that of Ms. Clinton or Candidate Trump—is to succeed in lowering prescription drug prices, both candidates would be well-served to remember that years ago, at a press conference after a Pfizer Board meeting, then-CEO Henry McKinnell commenting on remarks by Minnesota Governor Tim Pawlenty said that efforts to lower prescription prices were nothing more than “a Prairie Fire that breaks about every four years as an election issue and then burns out.’’

“It is time to end the pricing abuses of Pharma and to implement policies that will lead to the health benefits that only access to safe, affordable prescription medicines can provide. Failure to do so will once relegate the rights of Americans to enjoy the benefits of good health such access can provide in the ‘ashes of yet another Prairie Fire.’

News Release: We Can’t Wait:Personal importation of prescription medicines offers lower costs, health benefits for Americans

Personal Importation of Brand-Name Drugs Primary Campaign Issue for Senators, Representatives

The cost of illness and denial of the rights of Americans to have access to good health is too immense for further delays especially when it is within the ability of Congress to offer a solution

— Daniel Hines

ST. LOUIS, MISSOURI, USA, July 26, 2016 /EINPresswire.com/ -- The publisher of RxforAmericanHealth says that Election 2016 is an opportunity to demand the next Congress make the enactment of personal importation of brand-name prescription medicines a legislative priority.

Daniel Hines explains that for more than a quarter-century, Americans have been victims of the predatory pricing practices of Pharma.
“It is time for a change! American patients can’t way any longer!,” he says, “especially when there is an answer—personal imporation can provide the touchstone for a bi-partisan approach to comprehensive legislation to allow Americans the health benefits of access to vital personally imported maintenance medicines that would otherwise be unaffordable.
“Such access could very well be a key to deterring the illness and physical deterioration that too often lead to more drastic devastating illness that will require specialty medicines,” Hines says.
“That is why AmericanRxBillofRights has submitted its Articles defining the rights of Americans to enjoy the health and personal well-being benefits of access to safe, affordable prescription brand-name medicines from licensed, registered pharmacies from Tier One Countries whose standards of efficacy and safety meet or exceed those of the U.S. before Representatives, Senators and even the Platform Committees of the Republican and Democratic parties, “ he continues.
Hines says the challenge lies with our political leadership. 
“The Presidential candidates have offered their support of many of the provisions laid out in the AmericanRxBillofRights. It is now the voters who must call out their Congressional candidates to demand answers about the harmful impacts of the predatory pricing practices of Pharma.”
He outlines the results of the failure of Congress to act:
Result #1—A denial for millions of Americans to be able to exercise their right to the health benefit made possible from access to a regimen of vital life-line brand-name medicines, simply because they are unaffordable;
Result # 2—The ‘hoped-for’ answer to the scourge of unaffordable medicines—generic medicines—have seen price spikes that have made many of them equally unavailable to American patients;
Result # 3—Literally millions of Americans suffer from diseases—many of them life-threatening—raising the question of a possible link to the cause-effect impact of unaffordable but vital maintenance medicines that could have benefitted patients and deterred the harmful effects of their disease;
Result # 4—Pharma raises prices, on specialty medicines to thousands of dollars for treatments, even though many of the costly medicines are older, lower-cost medicines, and manufacturers are simply taking advantage of the illness of Americans; 
Result # 5—Congress becomes indignant, holds hearings, witness testify, advocacy groups coalesce to ‘address’ price challenges, but…prices remain high, Congress continues with more hearings…and Americans continue to pay the highest prices in the world…WHY?;
Result #6--Because Pharma and its allies in the House of Representatives and the U.S. Senate who are the beneficiaries of Pharma’s extensive contributions have controlled the discussion on how to lower prescription and health care costs while Pharma continues to rake in obscene profits, and American patients continue to be denied their medicines. 
He then suggests that voters demand answers to a series of questions from Representatives, Senators and candidates:
1. In light of the wide-spread bi-partisan support of personal importation for at least 16 years, sponsorship and support of legislation from the leadership of both political parties including the President, and the three major candidates of the Democratic and Republican Party this year, why has there been no adoption of personal importation;
2. If the answer is the ‘certification’ of the safety of the medicines by the Secretary of Health and Human Services, could you please provide the names and responsibilities of other Cabinet members who are legislatively made personally responsible for certifying the health impact of regulations, decisions, policies of their particular departments? 
3. There are many groups that are being formed to ‘study’ the harmful impacts of recent price increases such as the spike in generic drug costs, and, of specialty medicines. Many of you have exhibited leadership in hearings about these issues. Unfortunately, the new groups being formed will require time—perhaps more than a year—to develop a consensus on the scope of the problems. Strategies to address the challenge of high prices will take even longer, ironically, since enactment of legislation to allow personal importation can offer immediate relief.
4. And, this leads to a final set of questions:
a. If you are not a sponsor or co-sponsor of a bill to allow personal importation, why not? If you are a supporter of personal importation, why do you believe your efforts have not gained traction?
b. Have you received contributions from the Pharmaceutical industry?
c. Does the problem lie within Congress itself? For years, the Democrats controlled the House and Senate. Now, the Republicans have had control of the House and Senate for six years, and have failed to even bring the issue to a vote. Does this indicate that politics take precedence over the health of your constituents?
d. Irrespective of the cause, what is your strategy to advance the case for personal importation and lowering prescription drug costs? 
e. Are there stumbling blocks that public action by advocacy groups and the millions of Americans for whom personal importation is a vital lifeline, can help remove?
“Relief will come only when the American voter finally speaks up and takes the initiative to clearly demand that Congress act, “ Hines says. “Americans pay the highest costs for prescription medicines in the world. We truly Can’t Wait anymore. The cost in terms of illness, costs, and denial of the rights of Americans to have access to good health is too immense for further delays especially when it is within the ability of Congress to offer a solution.”

We Can’t Wait: Making the case for Personal importation of prescription medicines as the primary immediate health care tool to lower costs and provide benefits to the health and well-being of Americans

For more than a quarter-century, Americans have been victims of the predatory pricing practices of Pharma.

It is time for a change! American patients can’t wait any longer!  

There is an answer, a strategy that can provide the touchstone for a bi-partisan approach to comprehensive legislation to allow Americans the health benefits of access to vital maintenance medicines, access that could very well be a key to deterring the illness and physical deterioration that too often lead to more drastic devastating illness that will require specialty medicines.

That answer is personal importation of brand-name prescription medicines from licensed, registered Pharmacies in Tier One countries whose standards of safety and efficacy meet or exceed those of the U.S.

That is why AmericanRxBillofRights submitted its Articles defining the rights of Americans to enjoy the health and personal well-being benefits of access to personally imported medicines to Representatives, Senators and even the Platform Committees of the Republican and Democratic parties.

We did this because the challenge lies with our political leadership.  The Presidential candidates have offered their support of many of the provisions laid out in the AmericanRxBillofRights, so it is now the voters who must call out their Congressional candidates to demand answers about the harmful impacts of the predatory pricing practices of Pharma.

The first step is to define the results of the failure of Congress to act, and why we can’t wait any longer. Consider the results of Congress’ failure:

• Result #1—A denial for millions of Americans to be able to exercise their right to the health benefit made possible from access to a regimen of vital life-line brand-name medicines, simply because they are unaffordable;

• Result # 2—The ‘hoped-for’ answer to the scourge of unaffordable medicines—generic medicines—have seen price spikes that have made many of them equally unavailable to American patients;

• Result # 3—Literally millions of Americans suffer from diseases—many of them life-threatening—raising the question of a possible link to the cause-effect impact of the denial of vital personally imported maintenance medicines that could have benefited patients and deterred the harmful effects of their disease;

• Result # 4—Pharma raises prices on specialty medicines to thousands of dollars for treatments, even though many of the costly medicines are older, lower-cost medicines, and manufacturers are simply taking advantage of the illness of Americans;

• Result # 5—Congress becomes indignant, holds hearings, witness testify, advocacy groups coalesce to ‘address’ price challenges, but…prices remain high, Congress continues with more hearings…and Americans continue to pay the highest prices in the world…WHY?;

• Result #6--Because Pharma and its allies in the House of Representatives and the U.S. Senate who are the beneficiaries of Pharma’s extensive contributions have controlled the discussion on how to lower prescription and health care costs Pharma continues to rake in obscene profits, and American patients continue to be denied their medicines.

• Here is a series of questions to ask the candidates in your Congressional districts and U.S. Senate races:

• 1.     In light of the wide-spread bi-partisan support of personal importation for at least 16 years, sponsorship and support of legislation from the leadership of both political parties including the President, and the three major candidates of the Democratic and Republican Party this year, why has there been no adoption of personal importation;

• 2.    If the answer is the ‘certification’ of the safety of the medicines by the Secretary of Health and Human Services, could you please provide the names and responsibilities of other Cabinet members who are legislatively made personally responsible for certifying the health impact of regulations, decisions, policies of their particular departments?

• 3.    There are many groups that are being formed to ‘study’ the harmful impacts of recent price increases such as the spike in generic drug costs, and, of specialty medicines.  Unfortunately, the new groups being formed will require time—perhaps more than a year—to develop a consensus on the scope of the problems. Strategies to address the challenge of high prices will take even longer, ironically, since enactment of legislation to allow personal importation can offer immediate relief.

• 4.    And, this leads to a final set of questions:

• a.    If you are not a sponsor or co-sponsor of a bill to allow personal importation, why not?  If you are a supporter of personal importation, why do you believe your efforts have not gained traction?

• b.    Does the problem lie within Congress itself?  For years, the Democrats controlled the House and Senate. Now, the Republicans have had control of the House and Senate for six years, and have failed to even bring the issue to a vote.  Does this indicate that politics take precedence over the health of your constituents?

• c.     Irrespective of the cause, what is your strategy to advance the case for personal importation and lowering prescription drug costs?

• d.    Are there stumbling blocks that public action by advocacy groups and the millions of Americans for whom personal importation is a vital lifeline, can help remove?

Relief will come only when the American voter finally speaks up and takes the initiative to clearly demand that Congress act.  Americans pay the highest costs for prescription medicines in the world.  We truly Can’t Wait anymore.  The cost in terms of illness, costs, and denial of the rights of Americans to have access to good health is too immense for further delays especially when it is within the ability of Congress to offer a solution.

Time for A Congressional Caucus to support Congress moves on Personal Importation

Publisher’s Note:  In this post, we applaud the introduction of bills in Congress in support of personal importation, while questioning the breadth of Congressional knowledge of the extent of the harmful consequences of protecting the safe haven provided in the US for the highest prescription prices in the Industrial World.  We continue our call for an Rx Bill of Rights for Americans, and urge that Congress form a Congressional caucus for Personal Importation as a first step to ensure that the vast numbers of Americans adversely affected by Pharma pricing have a voice in shaping health policies and continue to utilize the health and fiscal benefits made possible by personal importation.

Some simple questions for Congress:

• Has it finally realized that rising prescription medicine costs have created a national awareness by Americans of the harmful impact of the predatory pricing practices of Pharma upon their finances, their health and well-being?
•  Is it finally willing to accept the responsibility and opportunity created by a Maine Circuit Court ruling earlier this year that set aside a state legislature action that would have merely extended a practice of Maine Citizens for years—personally importing safe, affordable prescription medicines from Canada, Australia, New Zealand and The United Kingdom—a decision made not because the medicines were unsafe or even that personal importation was illegal, but because it is Congress’ responsibility and is within its authority to determine how personal importation should be implemented, an issue that it has favorably considered many times by members acting on the ‘reservoir of good will’ towards personal importation?
•  Is it finally convinced that Pharma will stop at nothing to justify price increases for specialty medicines that, while admittedly creating much-needed cures, threaten the very stability of our financial system, the health care system, and present the specter of rationing?
         o   Pay and Delay to protect generics from entering the market?
• o   Purchasing products from other companies and then raising the prices?
  o   Claiming extraordinary R&D investments when in reality a high percentage of the ‘new’ medicines are created through grants to University laboratories from the National Institute of Health, a governmental and tax-payer-funded entity?
  
  
• Is it finally convinced that prescription drug prices are indeed a major driver of health care costs, despite what some so-called experts have pooh-poohed as not possible because the ‘price’ of medications is ‘small’ and there would be no benefit from a major reduction of prescription medicine prices?
• Is it finally convinced that a medicine that is ‘unaffordable’ is equally indeed ‘unavailable’, and that this is the reason that as many as 55 million Americans fail to adhere to their prescribed regimen of taking their medicines simply because they cannot afford them, and does it accept responsibility for the likely harmful consequences of this?
•   Is it even vaguely aware of the potential for abuse of Section 708 of the Food Drug Administration Safety Innovation Act (FDASIA) which says a drug may be considered ‘illegal’ by the FDA because of a slight difference in labeling even though it is a perfectly safe, valid brand-name medicine that is the same as the medicine sold in the US at prices at prices as much as 60 percent higher, and will be subject to seizure and destruction?         

• Is it prepared for the spectacle of an agency ostensibly designed to protect the health and well-being of Americans—the FDA—seizing Americans’ medicines, holding them for an individual to ‘appeal’ the seizure (a complete sacrilege of the rights of Americans to due process by making their personal property subject to what are invalid seizures of their personal property, i.e., safe, valid medicines) and then, the eventual possible destruction of those medicines?                                                                       

Now, Congress has once again introduced two bills—S.122, co-sponsored by Senators John McCain (R-AZ) and Amy Klobuchar (D-MN), and HR 2228, sponsored by Representative Chellie Pingree (D-ME 1)  Dana Rohranbacher (R-CA 48)

The bills are designed to allow the personal importation of safe, affordable medicines from Canadian pharmacies.

The chances of passage are slim to none according to https://www.govtrack.us/congress/bills/114/hr2228 which gives each bill a less than four percent chance of passage, leading us to our list above of questions for Congress.

We are recommending something more--that the sponsors of the bills send ‘Dear Colleague’ letters and engage in colloquies with their fellow members. Most importantly, we believe it is time for the formation of a Congressional Caucus comprised of Senate and House members to act in support of personal importation legislation, and to also allow Americans a place at the table thereby generating additional awareness of what the consequences will be of Pharma unchecked.  This will, thereby provide the basis for an Rx Bill of Rights for Americans, which could also act as a strategy map for lowering the outrageous pricing practices of Pharma.

New Study: Proposed Medicare Part D Rule Would Increase Medicare Costs $24 Billion, Hike Senior Premiums

  

WASHINGTON, March 11, 2014 /PRNewswire-USNewswire/ -- A new actuarial study released by The Pharmaceutical Care Management Association (PCMA) examining the impact proposed changes to the Medicare prescription drug program finds that eliminating preferred pharmacy networks in Part D would increase premiums by approximately $63 annually for over 75 percent of Part D enrollees and raise overall program costs by an estimated $24 billion over the next ten years.

"CMS' proposal to eliminate preferred pharmacy networks will make it harder and more expensive for seniors to access prescription drugs," said PCMA President and CEO Mark Merritt.

The study examines the sections of CMS' proposed rule on preferred pharmacy networks. Currently, more than 75 percent of Part D beneficiaries are enrolled in plans that feature preferred pharmacy networks.

Key findings from the study, which was sponsored by PCMA and prepared by Oliver Wyman, include:

• As of February 2014, more than 75% of prescription drug plans (PDP) enrollees are in plans with preferred pharmacy networks and these enrollees could be adversely affected by the elimination of plans utilizing preferred pharmacy networks.

• The preferred pharmacy networks provision would increase premiums for the affected population by an average of approximately $63 per year for the 2015 plan year.

• The rule could increase cost sharing among PDP enrollees by an average of $80 to $100 per year.

• Since the rule would inflate the national average benchmark for Part D plans, CMS would pay an estimated additional $64 in direct subsidies per beneficiary per year in 2015, for a total increased payment of nearly $1.5 billion in 2015 across all PDP enrollees, based on Part D enrollment of approximately 23 million beneficiaries.

• Over a 10-year period, the increased cost of eliminating preferred pharmacy networks is estimated to be approximately $990 per affected enrollee, and the cost would be approximately $24 billion to CMS in the form of higher direct subsidy payments.

Oliver Wyman's findings are generally consistent with a separate Milliman analysis that found the entirety of the proposed rule will increase Part D costs by up to $1.6 billion in 2015.

In addition, a recent poll found that seniors in plans with preferred pharmacy networks are overwhelmingly satisfied, citing lower costs, convenient access to pharmacies and other benefits, according to a survey from Hart Research Associates. The survey found that 85 percent of seniors surveyed are satisfied with their preferred network plan. In addition, the survey found that four in five seniors would be disappointed if their preferred network plan is eliminated.

The Medicare Payment Advisory Committee has warned CMS that the proposed changes to preferred pharmacy networks could lead to disruptions in beneficiaries' access to medicines.

PCMA represents the nation's pharmacy benefit managers (PBMs), which improve affordability and quality of care through the use of electronic prescribing (e-prescribing), generic alternatives, mail-service pharmacies, and other innovative tools for 216 million Americans.

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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.  

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