Friday, September 30, 2016

Publisher Lauds Committee for Mylan investigation, says time for Congress to pass legislation cutting Drug Prices


It is time for the American voter to hold Congress accountable and demand the end to Pharma pricing abuses as exemplified--this time--by Mylan

ST. LOUIS, MISSOURI, USA, September 29, 2016 /EINPresswire.com/ -- The publisher of TodaysSeniorsNetwork, which includes RxforAmericanHealth and the AmericanRxBillofRights, has lauded the members of the House of Representatives Oversight Committee for its vigorous questioning of both Mylan Chief Executive Officer Heather Bresch and Dr. Douglas Throckmorton, Deputy Center Director for Regulatory Programs of the Food and Drug Administration, in recent hearings about the continuing EpiPen price scandal, but says Congress must ask itself about its failure to end Pharma pricing abuses.

“It is gratifying to see bi-partisan consensus on the dramatic, undesirable consequences affecting the health and well-being of American citizens because of the predatory pricing practices of Pharma,” Daniel Hines said in a letter to Committee members.

“Hopefully the expressions of outrage and indignation by the members are a prelude to Congressional action to end Pharma’s charging not just what the traffic will bear but what it determines to be necessary to inflated profits despite the harmful consequences to patients that simply cannot afford their medicines.”

But, Hines notes, there are questions that remain unanswered, and must be directed to not Pharma but to Congress.
“The questions should be asked by voters across the country as Congress prepares to recess before the elections,” he says. "It's in the voters' hands."

The questions include, When will Congress act? What will it take to make it act? Why has it not acted before, choosing instead to hold what seem to be endless ‘investigations? How does the FDA ignore previous Congressional Direction? What penalties are there other than fines for Pharma’s errant actions and misleading Congress? What is the harmful effect of unaffordable maintenance medicines that are a vital lifeline to patient? Why has Congress not implemented allowed personal importation of brand-name medicines from Tier One Countries to ensure that Americans have access to such a vital life-line?

In his letter to Committee members, Hines asked the following questions:
1. Throughout the hearing, Committee members noted that ‘they had been here before’, charges were leveled against Ms. Bresch’s statements calling them ‘rope-a-dope,’ ‘a shell game,’ and suggesting that perhaps this will be the impetus that will finally lead to Congressional action. But, If this latest example of Pharma abuse does not lead to Congressional action, what will it take? When will Congress act? Why is there a delay?
2. The testimony of Dr. Throckmorton, M.D., and his non-responsive answers to requests from the Committee, were appalling. His refusal to share information with the Chair of the Committee was particularly troublesome, and is indicative of the FDA, an agency ostensibly designed to protect the health and well-being of Americans, claiming equal status with Congress. Another example of such a blatant rejection of Congressional oversight is its refusal to implement ‘march in’ rights for more than 35 years, even in light of a recent bi-partisan Congressional request from 51 members of Congress. ‘Why does Congress allow the FDA to act in such an authoritative manner, refusing to acknowledge Congressional oversight?’ Also, why did the FDA reportedly deny the application of Teva for a competitive product to EpiPen on the basis of patent exclusivity of the design of the Mylan product?
3. The Wall Street Journal and others report that Ms. Bresch “underreported” Mylan profits by 60 percent, manipulating tax payment claims that, according to the WSJ did not apply to Mylan. Senators Amy Klobuchar (D-MN), Chuck Grassley (R-IA) and Richard Blumenthal (D-CT) have asked the Department of Justice to investigate whether Mylan has committed fraud. Will this claim be investigated further by Congress or DOJ? If the charge is found to be true, what will be the result?
4. There was a consensus on the Committee that a medicine that is unaffordable is, in and of itself, unavailable. You can’t buy what you can’t afford. But, millions of Americans have for years been denied the health benefits of access to a regimen of their prescribed medicines. It is virtually impossible to estimate the adverse impact to the health of individuals and society that have occurred simply because they can’t afford their medicines, due to Pharma and the FDA ignoring previously adopted directives to the FDA and HHS to explore and facilitate what is a readily available, affordable and safe resolution to the fact that Americans pay the highest prescription prices in the world—i.e., the personal importation of safe, affordable 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.
5. Congress has introduced legislation that would allow personal importation many times over the past 15 years. Millions of Americans have personally imported their medicines for years despite by FDA and Pharma opposition. Both current Presidential candidates support some form of personal importation of prescriptions from Canada and Tier One Countries as a means to lower prescription costs. There are bi-partisan bills for personal importation that have been introduced in the current Congress. But the FDA claims it cannot verify the safety and efficacy of drugs produced outside this country and that are personally imported , although it works with Pharma to provide oversight of the more that 80 percent of the prescription ingredients that are produced outside the U.S., and has stated that it is seeking greater cooperation with counterpart oversight agencies outside the U.S. Added to this is that while millions of Americans have been denied access to affordable medicine because of Pharma pricing practices, millions more have turned to personal importation of safe, affordable medicines for years, leading to the question, why does Congress fail to enact enabling legislation for personal importation?

Hines concludes, “One can only hope that the Mylan hearings will lead to a consensus-building initiative that will result in comprehensive legislation as outlined in the American Rx Bill of Rights and finally ending the ‘be damned’ attitude of Pharma.

Daniel Hines
TodaysSeniorsNetwork
636-399-2849
email us here

Open Letter to Members of Congress.Asks: What will it take to get Congress to act to lower prescription dug prices?

 
The following letter was sent to members of the House Committee on Oversight and Government Reform by Publisher Daniel Hines



Daniel Hines, Publisher, TodaysSeniorsNetwork
Phone: 636-386-5234
Fax:  636-386-5904
Cell Phone: 636-399-2849
Email: TodaysSeniorsNet@sbcglobal.net

Dear Members of the U.S. House of Representatives Committee on Oversight and Government Reform:

I am writing in my capacity of publisher of the TodaysSeniorsNetwork series of blogs dealing with issues facing an aging America and the need for policies to lower the costs of prescription medicines in the U.S. to applaud your intensive questioning of Mylan CEO Heather Bresch during your recent hearings.

It is gratifying to see such bi-partisan consensus on the potential of the dramatic, undesirable consequences affecting the health and well-being of American citizens because of the predatory pricing practices of Pharma. The many expressions of outrage and indignation are, hopefully, welcomed preludes to Congressional action to end Pharma’s attitude of charging not just what the traffic will bear but what it determines to be necessary to inflated profits despite the consequences to patients that simply cannot afford their medicines.

But there are questions that remain unanswered, and must be directed to not Pharma but to Congress:
1.     Throughout the hearing, members of the Committee noted that ‘they had been here before’, charges were leveled against Ms. Bresch’s statements calling them ‘rope-a-dope,’ ‘a shell game,’ and suggestions that perhaps this will be the impetus that will finally lead to Congressional action.  While such comments are welcomed, question must be asked: “If this latest example of Pharma abuse does not lead to Congressional action, what will it take?  When will Congress act?  Why is there even a delay?
2.     The testimony of Douglas Throckmorton, M.D., Deputy Center Director for Regulatory Programs of the Food and Drug Administration, and his non-responsive answers to requests from the Committee, while not surprising, were appalling.  His refusal to share information with the Chair of the Committee was particularly troublesome, but is indicative of the FDA, an agency ostensibly designed to protect the health and well-being of Americans, claiming an equal status with Congress.  Another example of such a blatant rejection of Congressional oversight was its refusal to implement ‘march in’ rights for more than 35 years, even in light of a recent bi-partisan Congressional request from 51 members of Congress for such action.  A question that must be addressed is ‘Why does Congress allow the FDA to act in such an authoritative manner, and to basically refuse to acknowledge Congressional oversight?’  Also, why did the FDA reportedly deny the application of Teva for a competitive product to EpiPen on the basis of patent exclusivity of the design of the Mylan product?
3.     As I write this letter, the Wall Street Journal is reporting that Ms. Bresch “underreported” Mylan profits by 60 percent, manipulating tax payment claims that, according to the WSJ did not apply to Mylan.  This leads to two questions: Will this claim be investigated further by the Committee?  If the charge is found to be true, will that lead to the possibility of a perjury charge?
4.     It was especially gratifying to note that there was a consensus among many members of the Committee that a medicine that is unaffordable is, in and of itself, unavailable.  You can’t buy what you can’t afford.  But, millions of Americans have for years been denied the health benefits made possible by access to a regimen of their prescribed medicines.  It is virtually impossible to estimate the adverse impact to the health of individuals and society that have occurred simply because they can’t afford their medicines. This is due to Pharma and the FDA ignoring previously adopted directives to the FDA and HHS to explore and facilitate what is a readily available, affordable and safe resolution to the fact that Americans pay the highest prescription prices in the world—i.e., the personal importation of safe, affordable 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.
5.     Ironically, for many years, Congress has introduced legislation that would allow such personal importation.  Both Presidential candidates support some form of personal importation of prescriptions from Canada and Tier One Countries as a means to lower prescription costs.  There are bi-partisan bills for personal importation that have been introduced in the current Congress.  But the FDA claims it cannot verify the safety and efficacy of drugs produced outside this country, although it works with Pharma to provide oversight of the more that 80 percent of the prescription ingredients that are produced outside the U.S., and has stated that it is seeking greater cooperation with counterpart oversight agencies outside the U.S.  Added to this is that while millions of Americans have been denied access to affordable medicine because of Pharma pricing practices, millions more have turned to personal importation of safe, affordable medicines for years, leading to the question, why does Congress fail to enact enabling legislation for personal importation?

In conclusion, it, one can only hope that the Mylan headings will lead to a consensus-building initiative that will result in comprehensive legislation as outlined in the American Rx Bill of Rights included with this letter. Thank you for your consideration of the issues presented.  We respectfully urge action to finally address the harmful impacts of the predatory pricing practices of Pharma, resulting in improved health and well-being of Americans.

Respectfully submitted,
Daniel Hines
Daniel Hines

The Articles of the American Rx Bill of Rights
It is time to call out the harmful effects of the undue influence of Pharma upon public health policy.  It is time for an Rx Bill of Rights on behalf of All Americans
Article One (A Basic Right to Good Health)

The impact of millions of Americans being denied the health benefits of access to a regimen of safe, affordable medicines because of cost is a national health issue that has yet-to-be-recognized consequences.  That is why the ability of American Citizens to make health care decisions in concert with their physicians such as the purchase of personally imported safe, affordable prescription medicines should not be hampered by any actions by government or private entities as a policy to restrict Americans' access to authentic medicines. 
Article Two (An Unaffordable Medicine is Unavailable)

A prescription medicine that is unaffordable is unavailable, thereby meeting the 'rules' of the FDA that such a medicine that is otherwise unavailable is indeed eligible to be personally imported by an American patient, Arbitrary denial by the FDA to such access is detrimental to the health of the patient  by denying him or her access to vital maintenance medicines. This is a violation of the purpose of the FDA which is ostensibly designed to protect the health and well-being of American citizens.

Article Three (Citizens as Stakeholders)

The relationship between the FDA, elected officials, and Pharma has led to numerous abuses, access by Pharma to legislators and other elected officials based on the contribution of millions of dollars, favored status for Pharma representatives and their front groups as the primary representative at public hearings to determine the health care policy for Federal, State and Local Governments, thereby skewering the decision-making process.  That why it is incumbent upon Congress that it act to ensure that ordinary American citizens whose health and finances are adversely affected by Pharma pricing practices, advocacy groups other than those of Pharma, are given a 'stakeholder' status equal to that of Pharma.

Article Four (Due Process)
Americans who purchase safe, affordable medicines from licensed, registered pharmacies in Tier One Countries whose standards meet or exceed those of the U.S., are the legitimate owners of their authentic medicines and are entitled to exercise their due process rights to have their personal property free from undue and unjustified seizure oar destruction by any governmental agency unless the seizing authority can demonstrate via established judicial processes and to courts that such seizures are of bogus, counterfeit or unsafe prescription medicines.

Article Five (Public Interest)
Americans are significant contributors to the development of research and development costs of new medicines through their tax dollars in support of grants to the National Institutes of Health (NIH), and, as such, should be protected from unfair or questionable patent protection granted to Pharma that fails to recognize the rights of American citizens. Abuses in pricing, illegal business activities, or undue influence upon policy-making by the FDA or elected officials should result in a reduction of the patent protection afforded Pharma to the detriment of untold numbers of Americans who must be able to pay what Pharma believes the traffic will bear.

 Article Six (Reciprocity)
The FDA should extend reciprocity to other Tier One countries in the interests of the health of American citizens. The majority of brand name prescription medicines sold to Americans is manufactured at plants outside the U.S., under FDA supervision, or at plants licensed by Pharma members to produce medicines under a license granted by a particular company, a validation that medicines produced outside the U.S. and sold in this country are indeed capable of being safe.  Also, the FDA has entered into agreements with regulatory agencies in many countries to assume the task of overseeing ingredients manufacture of ingredients for brand name medicines.  Added to that is that many countries (excluding the U.S and the FDA) have reciprocal agreements (Memorandums of Understanding) that one country will accept the medications produced in another country as safe and authentic.


BLUMENTHAL, GRASSLEY, KLOBUCHAR CALL FOR DEPARTMENT OF JUSTICE TO CONSIDER INVESTIGATING MYLAN

Mylan may have knowingly misclassified the EpiPen in order to reap huge profits at the expense of states and taxpayers

Mylan might be target of DOJ investigationWASHINGTON, D.C., September 30, 2016 – U.S. Senators Richard Blumenthal (D-CT), member of the Judiciary Committee, Chuck Grassley (R-IA), chairman of the Judiciary Committee, and Amy Klobuchar (D-MN), ranking member of the Judiciary Subcommittee on Antitrust, Competition Policy, and Consumer Rights, have called on the Department of Justice (DOJ) to consider investigating whether Mylan Pharmaceuticals violated the law when it apparently misclassified its EpiPen product in order to pay a lower rebate to states and reap huge profits at the expense of taxpayers.

“The American people have been rightly outraged as Mylan engaged in substantial price increases that resulted in billions of dollars paid by U.S. consumers,” the Senators wrote. “They deserve to know whether the company also violated the False Claims Act and diverted millions of dollars from U.S. taxpayers.”

More than ten years ago, Mylan classified EpiPen as a “Non-Innovator Multiple Source Drug,” or generic drug, for purposes of the Medicaid Drug Rebate Program. In order to protect states from high pharmaceutical prices, the Medicaid Drug Rebate Program requires drug companies to pay a percentage of their revenues to states in the form of rebates. Under this program, companies like Mylan are required to pay a higher rebate for brand-name drugs than for generic drugs. In a letter to the DOJ today, the Senators cited evidence that Mylan may have knowingly misclassified EpiPens, potentially in violation of the False Claims Act and other statutes. 
                                                                                   
The text of the letter is available here and below.

Dear Attorney General Lynch:

We write to inquire whether the Department of Justice has considered an investigation into whether Mylan Pharmaceuticals violated the law when it apparently misclassified its EpiPen product for purposes of the Medicaid Drug Rebate Program.

Congress created the Medicaid Drug Rebate Program to protect states from high pharmaceutical prices by requiring drug companies to pay a percentage of their revenues to states in the form of rebates. Crucially, the Medicaid Drug Rebate Program distinguishes between “innovator drugs”—new products that are generally insulated from generic competition by patents—and “non-innovator multiple source” (NIMS) drugs—older products that are available from multiple sellers. Companies pay a rebate of 13 percent of the price of non-innovator drugs. For innovator drugs, sellers pay a minimum rebate of 23.1 percent, but they can pay far more for drugs that experience large price hikes.

Pharmaceutical companies are responsible for determining whether their products are innovator or NIMS drugs. Companies can reap huge profits, at the expense of the states and taxpayers, by misclassifying innovator drugs as NIMS drugs. In the past, the Department has secured settlements against drug companies under the False Claims Act for such practices—including against Mylan Pharmaceuticals.[1]

Mylan has classified the EpiPen as a NIMS drug since acquiring the product license in 2007. According to press reports, however, the Center for Medicare and Medicaid Services (CMS) has stated publicly that this is incorrect.[2]

The first indicator that the EpiPen should not be classified as a NIMS drug is the plain text of the relevant statute. Under section 1927(k)(7)(A) of the Social Security Act, for a drug to be classified as a NIMS there must be “at least 1 other drug product which . . . is rated as therapeutically equivalent.[3]” In other words, the NIMS drug must face an FDA-approved competitor. The EpiPen faces no such competitor, and it has not since Mylan began selling the product.


The second indicator comes from Mylan’s own behavior. The Medicaid Drug Rebate Program imposes a higher rebate on innovator drugs because innovator drugs are generally protected by patents. Shortly after Mylan began marketing the EpiPen, it sued Teva Pharmaceuticals for patent infringement, leading to a settlement that kept Teva out of the EpiPen market until late 2015.[4] During this timeframe, Mylan increased its prices dramatically, including a rise from $265 to $609 in the last three years.[5]

Thursday, September 22, 2016

Finance Republicans Call for Review of Rebate Practices for Mylan’s EpiPen

In Letter to HHS IG, Senators Express Concern over Reports of Potential Rebate Manipulation
 
WASHINGTON, September 20, 2016 – In a letter today, Senate Finance Committee Republicans requested a review of the Centers for Medicare & Medicaid Services’ (CMS) administration and oversight of the Medicaid Drug Rebate Program (MDRP) regarding Mylan’s EpiPen.  The letter, led by Chairman Orrin Hatch (R-Utah), was sent to Department of Health and Human Services (HHS) Inspector General (IG) Daniel R. Levinson.

“Manufacturer rebates play an important role in helping to offset the ever-increasing costs of prescription drug to the Medicaid program. The recent controversy surrounding Mylan’s prescription drug product EpiPen® raises questions about the controls in place to ensure that drug manufacturers are paying appropriate rebates,” the Senators wrote. “A thorough and timely review of these issues by the Office of the Inspector General will provide important information to Congress about how CMS is overseeing this significant part of the Medicaid program and where changes in policy need to be made to protect the program against these types of vulnerabilities in the future.”

The letter was signed by Senate Finance Committee Chairman Orrin Hatch (Utah) and Senators Chuck Grassley (Iowa), Mike Crapo (Idaho), Pat Roberts (Kan.), Mike Enzi (Wyo.), John Cornyn (Texas), John Thune (S.D.), Richard Burr (N.C.), Johnny Isakson (Ga.), Rob Portman (Ohio), Patrick Toomey (Pa.), Dan Coats (Ind.), Dean Heller (Nev.) and Tim Scott (S.C.).

The text of the letter is below:

The Honorable Daniel R. Levinson
Inspector General
U.S. Department of Health and Human Services
Office of the Inspector General
330 Independence Avenue SW
Washington, DC 20201

 Dear Inspector General Levinson:

As Members of the Senate Finance Committee (Committee), we have a responsibility to ensure the effectiveness and solvency of the Medicaid program. 

To that end, we, along with numerous of our colleagues in the Senate and House of Representatives, are concerned with recent reports about the potential manipulation of the Medicaid Drug Rebate Program (MDRP) and whether or not the Centers for Medicare & Medicaid Services (CMS) is conducting sufficient oversight on this issue.

The Medicaid program spent $42.7 billion in brand and generic drugs and received $19.9 million in manufacturer rebates in fiscal year 2014.[1] Manufacturer rebates play an important role in helping to offset the ever-increasing costs of prescription drug to the Medicaid program. 

The recent controversy surrounding Mylan’s prescription drug product EpiPen® raises questions about the controls in place to ensure that drug manufacturers are paying appropriate rebates. The categorization of prescription drugs as generics instead of branded drugs has real financial impacts on the MDRP.  

The National Association of Medicaid Directors (NAMD) recently raised their concerns on this issue in a memo to Congress where they wrote, “if EpiPen is considered a generic for Medicaid rebate purposes but is not an actual generic product, it appears Mylan is taking advantage of the MDRP.”[2]  NAMD went on to state that “[t]he classification of EpiPen (both the device and the drug administered through it) as a generic drug under the MDRP means the inflation protections applicable to brand drugs have not protected Medicaid programs from Mylan’s price increases over the years, and Medicaid programs have been subjected to the same increases in Average Wholesale Price (AWP) as commercial insurers and consumers.”[3]

The MDRP ensures that pharmaceutical manufacturers pay states a rebate off of the AMP. The percentage pharmaceutical manufacturers pay Medicaid is higher for brand drugs (23.1 percent) compared to generic drugs (13 percent), thus, Medicaid receives a lower rebate for drugs inappropriately categorized as generics.

Additionally, the MDRP has helped limit the effect of sharp increases in the prices of brand drugs on Medicaid for years by requiring pharmaceutical manufacturers to pay additional rebates if the costs of the brand drugs rises more than inflation. 

No such provision existed for generic drugs prior to the 2015 Bipartisan Budget Act.[4] As a result, misclassifying a brand drug as a generic insulated the manufacturer from paying Medicaid additional rebates when it increased the price of drugs. Finally, another provision in the MDRP requires manufacturers to offer state Medicaid programs the lowest price it offers to other payers, with some exceptions.

Pharmaceutical manufacturers, including Mylan, have previously been subject to enforcement action for misclassifying brand drugs as generic drugs. Mylan was one of four companies that in October 2009 entered into settlement agreements for a total of $124 million to resolve claims that they violated the False Claims Act by failing to pay appropriate rebates to state Medicaid programs for drugs paid for by those programs.[5]

Given the concerns raised by NAMD and the past behavior in this area, we are concerned that the controls in place, if any, are inadequate to ensure that Medicaid is receiving the full amount of rebates afforded to it by law. 

Therefore, we write to you today to join our Republican colleagues from the House Energy & Commerce Committee in their September 12, 2016, request that the Office of the Inspector General examine CMS’s oversight of the MDRP.
The Medicaid program is a vital part of our healthcare system and its financial viability is a critical area of concern for this Committee. 

A thorough and timely review of these issues by the Office of the Inspector General will provide important information to Congress about how CMS is overseeing this significant part of the Medicaid program and where changes in policy need to be made to protect the program against these types of vulnerabilities in the future. 

Monday, September 12, 2016

Grassley Seeks to Determine Whether Iowa Taxpayers Overpaid for EpiPens Under Medicaid

Senator Grassley calls for Mylan Response on EpiPen
WASHINGTON, September 12, 2016 – Sen. Chuck Grassley has asked the Iowa attorney general to review whether Iowa taxpayers have overpaid for EpiPens under Medicaid.  

It appears Minnesota taxpayers may have overpaid for EpiPens by more than $4 million in a single year because the product might have been misclassified under a rebate program. Grassley is concerned about whether Iowans also overpaid. 

“If Minnesota has been potentially overcharged to the tune of $4 million, so too could Iowa. And if that is the case, the people of Iowa ought to be reimbursed for the overcharge,” Grassley wrote to Iowa Attorney General Tom Miller.  “It goes without question that the people of Iowa work very hard for their money, which is why I have committed to intense oversight of not just the federal government and its spending habits, but oversight of private companies that profit handsomely off federal and state government programs supported by Iowans’ taxpayer dollars.  …

“Iowans are rightly concerned about the high price of EpiPens. Accordingly, I urge you to review whether the state of Iowa and the people of Iowa have been overcharged by the potential misclassification of Mylan’s EpiPen as a generic drug. Please advise on what steps you are taking, or intend to take, on whether Iowa was overcharged, and if so, by how much.”

Grassley said it also would be helpful to know how much the state of Iowa has spent on EpiPens in the past five years.  Grassley said he would appreciate a response by Sept. 20.

Grassley said that under the Medicaid drug rebate program, branded drugs and authorized generic drugs carry a higher rebate than generic drugs.  If Mylan’s EpiPen was classified as a generic drug, the company would have paid the lower rebate, perhaps incorrectly, causing states to pay more. Grassley is interested in whether an incorrect classification involving EpiPens has bearing for other companies and drugs in the rebate program and if so, whether adequate oversight of the program exists.

“This information will be helpful as Congress works to understand whether the generic drug classification system is working as intended and whether drug companies and the Centers for Medicare and Medicaid Services are fulfilling their responsibilities under the program,” Grassley wrote.

Grassley wrote that the Minnesota attorney general opened an inquiry into the EpiPen pricing and the effects on the people of Minnesota, including through the school system. 

Grassley began his inquiry on the high cost of EpiPens on Aug. 22, when he wrote to the manufacturer of the EpiPen, used for emergency treatment for life-threatening allergic reactions, seeking an explanation of the steep price increase in the product in recent years.  Grassley’s letter came after Iowans expressed concern to him about the prices.  

Grassley then led a letter from five senators to the Food and Drug Administration, seeking details on whether alternatives to the EpiPen are in the works.  He also was one of three senators who asked the Centers for Medicare and Medicaid Services regarding the effects of the price increases on public health care programs.  

The company has since announced expanded patient assistance programs and a generic version of the product.

Wednesday, September 7, 2016

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.’

Tuesday, September 6, 2016

Clinton recommendations to end Pharma pricing abuses, including a role for ‘emergency’ importation of medicines, proving that the FDA, Pharma and Pharma supporters have misled the American Public on the ability to ascertain the authenticity and safety of personally imported medicines

by Daniel Hines, Publisher

Election Issues facing an aging America
Hillary Clinton’s strategy to deal with lowering prescription prices is the most comprehensive approach employing several action steps that have previously been introduced only as individual actions reliant upon reaction to a series of Pharma price abuses.

As such, it represents hopefully an end to Pharma’s actions that have been based on its confidence that it can charge what the traffic will bear, thumbing its Collective nose at Congress and the American public.

Most importantly, its stand on imported medicines proves that the Food and Drug Administration Pharma and Pharma supporters have misled the American Public on the ability to ascertain the authenticity and safety of personally imported medicines!

 While GOP Candidate Donald Trump has indicated his support for strategies to lower prescription drug costs, he has yet to come forth with specifics to lower prescription drug prices.

Also, while the Democratic Party Platform specifically endorsed and supported a role for Personal Importation, an end-to-pay to delay and other steps to lower prescription drug prices, the GOP Platform had no mention of healthcare except for a call for repeal of the Affordable Care Act (ACA).

Additionally, former GOP Speaker of the House Newt Gingrich recently touted the GOP Platform as supporting ‘Pharma innovation and research and development’.  Gingrich specifically attacked the role of Personal Importation of brand-name medicines from Tier One Countries, asking only that the American public adopt a ‘trust us’ attitude towards Pharma.

An examination of Ms. Clinton’s proposal is triggered by a realization of the fact that unaffordable medicines are, in and of themselves, unavailable because of their unaffordability. 

At the same time, it is limited because it deals with ‘emergency-like’ crises that continue to occur with a disturbing frequency as Pharma continue its pricing abuses.  That’s why it is time that the Presidential candidates take a strong stand to enact permanent—not just temporary or emergency-related incidents.  Some thoughts on her plan follow:

  • ·       Her plan calls for implementation when drug prices are ‘threatening’ the health of Americans because the drugs are unavailable due to their price. This should be extended to unaffordable ‘maintenance’ brand-name drugs that millions of Americans rely upon as a vital link to their health and well-being;
  • ·       While her plan calls for ‘temporary,’ personal importation,  if she were elected, she likely would have to use executive orders to implement and utilize such a ‘temporary’ role for importation. That’s why Congress should end its seemingly endless delays,  investigations, statements, and business as usual;
  • ·       Her stance clearly calls upon medicines from what can only be construed as a reliance upon Tier One Countries with proven standards of safety and efficacy that meet of extend those of the U.S.;
  • ·       She points out that the Food and Drug Administration has in the past allowed such ‘emergency’ importation;
  • ·       This is a tacit admission and recognition of the fact that, contrary to repeated claims of the Food and Drug Administration regarding personal importation that :
    • o   It is indeed possible to monitor and certify the safety, authenticity of brand name medicines ‘imported’ to the U.S.;

o   The fact that such ‘importation’ would have to be implemented quickly to be of benefit indicates that the FDA also is capable of such validation of the sourcing, manufacture, packaging, safety and efficacy of imported medicines, particularly since it has for years cooperated with foreign sources for ingredients' oversight, and it has worked with regulatory agencies in other countries during previous ‘emergency’ importation;

o   The implementation of even a temporary importation’ program would be proof positive of the safety and efficacy of imported medicines as well as their immediate economic benefit, and, in the long-term, their favorable impact upon American’s health.  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 cannot become fraudulent after the ‘emergency’ is over.  Simply put, when a medicine—any medicine—is unaffordable, it is unavailable, and that unavailability creates a crisis and emergency situation for the individual denied access to vital medicines;

o   A ‘temporary importation’ would illustrate the contradiction of a policy that raises questions about the ‘legality’ of personal importation, since it clearly illustrates 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;

o   That benefit to medicines and the right to purchase them via personal 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—maintenance medicines that have been proven in the Rand study of enrollees in the Affordable Care Act to improve patient health and lower total drug spending;

o   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.  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;
o   There is a strong emphasis in the Clinton plan on the role of generics.  But, in what is can only be construed as an admission of the failure of such a previous 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 plan calls for fines and penalties to be assessed against Pharma and generic industry firms that are found to profit from excessive price increases;

o   The plan calls for an end to several key elements of Pharma strategies:  One is  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.

If any strategy—be it that of Ms. Clinton or Candidate Trump—is to succeed, 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.’’

Such a statement shows the contempt that Pharma has long held for the American political process—a contempt based upon Pharma’s extensive lobbying and millions of dollars in campaign contributions, including to Ms. Clinton.


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 again leave the rights of Americans to enjoy the benefits of good health such access can provide in the ‘ashes of yet another Prairie Fire.’