News about Prescription Medicines

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Tuesday, April 8, 2014

Proposed Section 708 Rules Promulgation On Seizures of imported medicines nears; Support petition to prevent unwarranted seizures, Denial of lifeline of vital medicines to Americans

One of the most potentially troublesome portions of S. 3187 (FDA Safety and Innovation Act)  is Section 708 regarding the handling and disposition of imported prescription medicines which,  under the authorization of the Secretary of Health and Human Services (HHS),  seized medicines determined to be counterfeit, bogus, misbranded or of potential harm to the health of American citizens, and determined to have a value of $2500 or less, may be destroyed by the agency making the seizure.

The rules promulgation process is nearing completion.  After the rules are presented for review and comment, there will be a 60-day period for stakeholders, including TodaysSeniorsNetwork and RxforAmericanHealth.blogspot.com, acting with other advocates of personal importation  on behalf of the more than one million Americans for whom personal importation provides a lifeline to vital drugs, to comment to urge rules that  protect their continued access to these safe, affordable medicines.

We anticipate that we will be a part of  a broad community of support, an indication of which is a petition that was recently launched by Dr. Stephen Barrett, a North Carolina physician who purchases his personal medications from an Internet Pharmacy.

Dr. Barrett’s Petition urges HHS Secretary Kathleen Sebelius to fully consider the potential harmful impact to the health of Americans by the unwarranted seizure and destruction of medicines that are safe and present no threat to Americans’ health.

We are heartened by Dr. Barrett’s concern about the potentially harmful outcome of the misapplication of any rules that might eventually emerge after stakeholders have the opportunity to be included In the development of the final rules and their implementation, and are pleased to preset the following information for your consideration and support.


Tuesday, March 11, 2014

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.

Tuesday, January 28, 2014

Pharma-driven Trans-Pacific Trade Talks veiled in Secrecy that will violate U.S. Constitution



Publisher’s Note:  This is the first of what will be a series of articles on the continued attempts by Pharma and its front groups to not only protect the ‘safe haven’ provided by the U.S.by allowing Pharma to  charge the highest prescription medicine prices among Industrialized Nations, but to extend their predatory pricing practices to other countries, not by innovation, but by being granted quasi-governmental  authority that would undermine the legitimate functions of governments around the world.
 
There are those who are speculating if the President is as indebted to Pharma interests as he was when, during the debate over the Affordable Care Act (Obamacare), the Administration granted Pharma and its trade group,, the Pharmaceutical Research and Manufacturers of America (PhRMA), unprecedented access to behind-closed-doors negotiations free of public oversight in the shaping of the legislation to avoid the special-interest industry group from opposing what the President viewed as his legacy legislation with a ‘Harry and Louise’-type campaign that sidelined Hillarycare during the Clinton Administration.

My response:  “You’ve got to be kidding....”

The latest incarnation of the President’s continued paying off his continued indebtedness to Pharma is evidenced by the Pharma-driven Trans-Pacific Partnership Treaty Negotiations, currently progressing in secret talks, free of Congressional oversight   or involvement.


The following is from the Senate website page clearly laying out the Constitutional responsibility and authority: 

The Constitution gives to the Senate the sole power to approve, by a two-thirds vote, treaties negotiated by the executive branch. The Senate does not ratify treaties. Instead, the Senate takes up a resolution of ratification, by which the Senate formally gives its advice and consent, empowering the president to proceed with ratification...”

As to the link to Obamacare, one only need examine the role of outgoing Senator Max Baucus, Chair of the Senate Finance Committee, and the driving legislative force in the Senate behind Obamacare.

The soon-retiring from the Senate but soon-to-be Ambassador to China, Senator Baucus has introduced legislation to allow Fast Track authority in line with the Administration’s wishes.  Unfortunately, he was also joined by Senator Orrin Hatch (R-UT), in what to the Administration is proof-positive of Bi-Partisan ‘support’.

It should be noted that Senator Hatch was also a supporter of the ill-advised Protect  Intellectual Property Act  (PIPA), which was also largely Pharma-driven as part of its never-ended attempt to deny Americans the right to safe, affordable prescription medicines from licensed, registered pharmacies in countries outside the U.S., with standards of safety and efficacy that meet or exceed those of the U.S.

He withdrew his support of the legislation after a huge public outcry, appealing for a reasonable solution to the issue of intellectual theft (which, of course, PIPA was not).

The Senator’s support of the Trans-Pacific talks indicate that he is still struggling with an understanding of reasonable solutions.

To be fair to the Senator, much of the problem involving determining the ‘reasonableness’ of such initiatives when Pharma is involved is that it cleverly masks its intentions through what I have described as ‘disingenuous connectivity’ by wrapping them with other issues ranging from health care to patent protection to international trade to even national security (at least when it comes to personal importation of prescription medicines).

The Trans-Pacific negotiations are filled with abuses. One of the best exposes of the problems with the negotiations that I have seen comes from TechRights.org.

But, lest anyone should think that the growing opposition to the Pacific Trade agreement is being directed by the President’s opponents, the following segment of the Ed Schultz Show on MSNBC, which no one will ever accuse of anything less than usually fawning over the Administration and the President, shows that even supporters are beginning to understand the ramifications of thispower grab by Pharma to claim extraordinary powers on the basis vagueness and secrecy.

The facts are self-evident:
a.      The President continues to meet his obligations to Pharma, in what is a wide-sweeping abuse of Constitutional authority that will have negative ramifications far beyond the end of his Administration;
b.      Pharma remains active on many fronts to protect its ‘safe haven’ of making the prices for vital prescription medicines the highest in the industrialized world;
c.       If successful in forcing the terms of the Trans-Pacific negotiations upon the Congress, a major erosion of Constitutional authority will occur, and, as was the case in PIPA and the ill-named Stop Online Piracy Act (SOPA) (yet another Pharma-driven bill), there will be unintended consequences that will affect American’s access to vital medicines by granting to Pharma extraordinary, quasi-governmental authority that could restrict access to vital medicnes, but also to further erode the already-declining lack of confidence in Congress,  and trust of the American people that they are represented by a government of and for the people’s health, happiness and well-being, rather than special interests.

Saturday, November 16, 2013

America's Leading Informational Website on Aging Issues

The Nov. 15, 2013 newsletter of America's leading informational website on aging issues, TodaysSeniorsNetwork, is now online. Stay informed on the many issues facing an aging America.  http://app.flashissue.com/newsletters/americas-leading-informational-website-on-aging-issues-7

Thursday, October 31, 2013

America's Leading Informational Source about Aging

America's Leading Informational Source about Aging


America's Seniors at TodaysSeniorsNetwork's latest newsletter is now online.  Click http://flsh.is/1aWNfsf to stay informed about these important issues of Aging in America.  Your one-stop source for all issues affecting elderly, caregivers, policy-makers, advocates.

Friday, March 15, 2013

Pharma practices ‘disingenuous connectivity’ in attacks upon personal importation

 Pharma, and its trade group PhRMA, are employing a strategy that is best described as ‘disingenuous connectivity’ in its latest strategies against personal importation of prescription medicines.

The strategy-- attempting to remove itself as the focus of attacks upon personal importation of safe, affordable medicines, from licensed, registered pharmacies in Tier One Countries whose standards of safety and efficacy for prescription medicines meet or exceed those of the US. 

Why does this constitute being disingeous?  Let's look at the Dictionary definition:

‘Witholding known information or giving a false impression of sincerity or simplicity’’. 

 This is what Pharma is doing in establishing relationships and connections with  erstwhile and commendable interest groups to persuade them to adopt the admirable goal of  prescription drug safety as a part of their mission, but one in which any imported medicines are by definition of being imported are, in and of themselves, ‘unsafe’.

 Some examples:  The Institute of Medicine,   a national Non-Governmental Organization designed to provide national advice on health and medical issues and to develop programs for  patient safety, have, in response to a request from the Food and Drug Administration  for a study on drug safety issued a statement calling for increased tracking and tracing of the worldwide pharmaceutical chain of custody.

 The IOM statement does base its appeal on recognition of the problems of admittedly bogus pharmacies and counterfeit medicines.  It is disturbing in other ways, however,  not the least of which is that  IOM has dropped the use of the word ‘counterfeit’ to describe fake medicines, choosing instead to restrict the term to encroachment of intellectual property rights, a Pharma goal in its failed PIPA and SOPA pushes. 

 Another  example:  In a recent article in the Journal of Nursing, the nurse community is urged to assist in counseling patients on drug safety, using standards that limit the application of a ‘safe pharmacy’ or source of personally imported medicines to only those in the US.

 The FDA is a major player in this effort.  Its new web site ‘identifying’  what it describes as ‘unsafe’ pharmacies uses the VIPPS program as a resource, an embrace that reflects the success  of the  National Boards of Pharmacy Verified Internet Pharmacy Practice Sites (VIPPS) program and opponents of personal importation to provide what might be a ‘gateway’ service designed to allow FDA and Pharma to claim, because there continues to be legislation empowering the FDA to contract selected services to privately sourced, third-party groups in the private sector to conduct safety oversight that normally would be a part of the FDA responsibility within the limits determined by Congress.

 As to prove the case, the Journal of Nursing refers nurses and patients to the FDA site and the VIPPS program as the ‘standards’ for safety.

  To imply that all medicines from licensed, registered pharmacies outside the US are unsafe does not stand in the light of facts. Many countries, especially those in Tier One Countries do have excellent standards of safety.  Add to this that virtually all prescription medicines sold in the US are manufactured at plants outside this country, meaning that even those medicines sold in NABP pharmacies, are likely imported into the US.

 The target of these programs is not prescription medicines that might be ordered from clearly identifiable bogus pharmacies on the Internet, but those safe sources from outside the US that provide as many as two million Americans access to safe, affordable prescription medicines that would otherwise be denied to them because of the predatory pricing practices of Pharma that have made the US a safe haven for the highest prescription drug prices in the industrialized world.

 No one disputes the need to ensure that Americans are made aware of the potential danger of bogus pharmacies, and providing Americans with the tools to identify such pharmacies. There are ample guidelines on identifying guidelines to ensure safety based on more than a decade of safe use of personally imported prescription medicines.

  For more than 12 years, seniors’ advocacy groups and others have made the case that access to safe, affordable medicines via personal importation is a matter of fact.

  Supporters of personal importation have published stories, guidelines, and have developed materials to help identify the validity of a pharmacy. The US Congress has repeatedly passed legislation in support of personal importation only to see it turned aside by ‘poison pill’ amendments brought forth by Congressional supporters of Pharma. 

 Even the FDA has taken actions that validate the claims of supporters of personal importation that the regulatory agencies of Tier One Countries meet or exceed those of the US and should therefore be the basis of approval for personally imported medicines, by moving to allow a form of reciprocity in the oversight and manufacture of ingredients for prescription medicines by regulatory agencies in countries outside the US.


 The answer:  this just another example of the disingenuous strategies of Pharma and others.

 There are more:

 PhRMA has launched a series of efforts to attain goals that it was denied by the legislative process, including what is cited as patent and trademark protection but really was nothing more than attempting to co-opt legislation by shaping it in a manner that reflected its goals of deterring personal importation. 

 The examples below amplify the case that Pharma is indeed engaged in a full scale attack upon personal importation with no concern for the vital lifeline it provides to untold numbers of Americans, or the fiscal impact to citizens being denied access to affordable medicines:

·         The drafting of a bill by the Senate Health Committee and House Energy and Commerce Committee in October 2012, written by staff members, free of any input from stakeholders. The ‘draft’ established the framework for the empowering of the FDA to enter into third-party relationships with the private sector granting the authority mentioned in the paragraph above.  The 118-page draft was not even submitted for consideration.  The question must be asked: Why not?  Is it still in someone’s desk drawer waiting to be pulled out for introduction in the 113th Congress, free of any opportunity for input from stakeholders? The language also focuses on ‘potentially’ unsafe medicines, a particularly troublesome term since there are no standards of what constitutes ‘potentially’ except for several mentions of ‘misbranded’ (read personally imported) medicines.

·         The FDA Reauthorization bill (PDUFA) calls for Rules Promulgation in the next two years.  Section 708 empowers the seizure of medicines dispensed by pharmacies in countries outside the US for Americans’ use by granting the power of seizure to Customs, Homeland Security, and Border Agents. Questions that must be asked and answered include but are not limited to:

o     When will FDA communicate the schedule on Rules Promulgation;

o    How will it ensure that all persons and groups desiring to make comments are notified?

o      The challenge:  the language as written gives authority for the Secretaries of HHS and Homeland Security to make seizures by Customs  and destroy them.  In a disturbing aside, Senator Bill Nelson (D-FL) , chair of the Senate Select Committee on Aging, and a supporter of personal importation, tells a senior advocate in Florida that he believes the action in 2007 when he and Senator David Vitter (R-LA) led legislation that ended FDA-Customs collusion resulting in seizures of personally imported medicines , is a precedent that will preclude such action now.  Unfortunately, he is incorrect.

·         FDA launches a website in an effort to ‘identify’ what it describes as ‘safe pharmacies’,  all within the US, again using the VIPPS model;

·         The Center for Safe Internet Pharmacies ‘launches’, a year after its founding.  The timing of the launch seems to be a part of a communications effort to attain a critical mass to determine the ‘message’ that the definition of safe pharmacies of safe pharmacies is applicable only to those in the US.  Again, the VIPPS model comes into play;

·         FDA issues a series of news releases, including statements from FDA Commission Margaret Hamburg, about the need for new initiatives in the chain of custody to guarantee the safety of the prescription medicine supply.  This comes only months after more than 60 people dying from unsafe medicines from a Massachusetts compounding pharmacy.

·         The problem with the counterfeit Avastin (bogus?) continues to be a mainstay of FDA releases.  The identification of potentially dangerous medicines is a commendable goal and important to protecting Americans, but there is no record of anyone becoming ill of dying from taking the Avastin.  The Federal government has commendably been diligent in its prosecution of offenders, many of whom are physicians.

·         The President of Eli Lily, angered by the refusal of Canadian authorities to approve a patent, suggests in a prepared statement that Lily is granted a degree of sovereignty equal to that of Canada due to the North American Free Trade Agreement, and , that companies such as Lily (and other Pharma companies?) have such a standing in not only NAFTA, but future trade agreements. What does this say about the sovereignty of a country like Canada...or even the US...and its authority to conduct its governmental functions?

·         PhRMA apparently has returned to the issue of controlling the Internet. But, apparently burned by its SOPA debacle, this time,  Pharma has the NABP acting on its behalf as it seeks a new domain designation for .pharmacy.  The .pharmacy designation would be specific for US-based pharmacies only, would disable Americans from having access to Internet pharmacies in other countries (including Canada), and would utilize, yes, the VIPPS list to determine approved pharmacies, in effect granting PhRMA the victory it was denied in the PIPA and SOPA battles.  Of interest, in its application for the .pharmacy designation, NABP declares that FDA, Pharma, other groups will conduct a vigorous communications and educational campaign on the significance of the new domain designation.  This is a move to encroach upon the freedom of the Internet and to attempt to utilize  .pharmacy for the special interests of NABP and Pharma.  It should receive the same vigorous opposition as the SOPA boycott.

Look for the pattern to hold true. The FDA is faced with budget cuts, plus Sequestration, Pharma is desperate to circumvent the openness of the legislative process with its demands for hearings, testimony, and, public statements from stake holders.  

 The goal is the silencing of seniors’ advocates and others who support the benefits that access to such a vital lifeline and savings from prescription medicines offered by personal importation. 
 
Pharma and its allies are opting for passage of administrative rules that the rules makers will adopt citing that they either has the power to make such decisions, and which it will attempt to validate through the passage of vaguely written ‘drafts’ crafted behind closed doors.

  It provides us with a new phrase to describe what we are witnessing:  disingenuous connectivity.  It is time for Congress to pull the plug.