News about Prescription Medicines

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Tuesday, March 17, 2015

People over 65 Struggle to pay for care


Wednesday, March 11, 2015

Why High Drug Prices require an RxBill of Rights for Americans (Part One)

Why High Drug Prices require an RxBill of Rights for Americans (Part One)
Publisher’s note:  This is the first of a three part series on why Americans need an RxBill of Rights that will guarantee their access to safe, affordable brand-name medicines from licensed, registered pharmacies in Tier One countries whose standards of Safety and Efficacy meet or exceed those of the US.  In Part Two, we will examine the abuse of the public policy process by Pharma to exercise undue influence that makes the US a safe haven for predatory pricing practices of Pharma, and what the potential public health care consequences are of that influence.  In Part Three, we will explore examples of the pricing policies of Pharma, including the concerns over the costs of ‘specialty’ medicines and the spike in Generics.  We will also present our case for an RxBill of Rights for Americans based on a role for the American public as a part of the stakeholder community with a specific interest in the costs of medicines, and having a role in the deliberative process of legislation, policy making and implementation of health care policy as it involves the benefit, savings and overall well-being, happiness and health of American citizens.


Then, imagine that when people who are supposed to represent your interests in an elective body turn instead to the very entities that are offered a ‘safe haven’in that country for those prices as ‘stakeholders’ to ‘invitation only’ opportunities to shape that country’s public health policy.

But wait!  Generic drugs can offer relief for the battered pocketbooks of people of this country, supposedly offering medicines at a fraction of the cost of the more expensive brand-name medicines...can't they?

Unfortunately, no...instead, these supposedly less-expensive alternatives are recognized as opportunities for immense profits merely by raising the prices by as much as nearly 1000 percent. 

And, imagine that when miraculous cures are found for diseases, that instead of a Jonas Salk model in which the founder of the vaccine to eliminate polio said that the rights to the cure were those of people around the world, the drug company that develops the medicine charges $1,000 a pill, putting the total cost to each individual (in this instance, Hepatitis C) a staggering $100,000, allowing the company making it to register 2nd Quarter profits of $3.67 billion.

Finally, imagine that this fictitious country had the capability to provide lower drug costs for all its citizens by allowing them to personally import valid, brand-name prescription medicines, from licensed registered pharmacies in Tier One Countries whose standards of safety and efficacy meet or exceed those of those in the U.S., and could offer those medicines at prices at as much as 60 to 80 percent less that the overly-expensive medicines currently protected.

Then imagine that those who oppose lower medicine prices use their vast funds, political contributions, front groups to deter the rights of the citizens of that country to purchase these medicines.

Unfortunately,  you don't have to imagine.  The country is very real.  It is the United States.

But there is a solution.  It rests with the United States Congress. Ironically,  a recent decision by a District Court Judge in Maine which opponents of personal importation hailed, might offer a road map to bold actions that could lead to lower prescription medicine prices.
While Pharma may believe that it has gained a victory in the ruling by Judge Nancy Torresen, Chief Judge of the United States District Court for the District of Maine, determining the right of the state of Maine to allow its citizens to personally import their medicines, it may want to pause before taking a victory lap.

Yes, the Judge’s decision did set aside the Maine law, passed by the state’s Legislature allowing Maine citizens to purchase brand-name medications from licensed, registered pharmacies based in Canada, the United Kingdom, Australia and New Zealand. 

The Legislature passed the law after the then-Attorney General, acting at the bequest of the state’s Pharmacy Board and the Maine Pharmacy Association, banned the sale of such pharmaceuticals because the pharmacies dispensing the medicines were not registered with the Main Pharmacy Board.

The Attorney General’s action occurred even though Maine Citizens utilizing the state’s proximity to Canada, have travelled across the border to purchase their medications for years, while others were purchasing their medicines through plans offered by businesses acting to make such safe, affordable prescriptions available to their employees through employee benefit plans.


The opponents to personal importation immediately initiated legal action based upon the contention of ‘Federal Supremacy’.  The issue for the courts was to determine federal law preempts state law when it comes to prescription drug imports.  She decided that it does.

Therein lies the basis of what has been a debate about the American process since our country’s founding—state rights and authority vs. that of the Federal Government over state actions.

Undoubtedly, the interest of PhRMA, acting on behalf of its members—and affiliated front groups—was based on fear that if the Maine legislation were to be upheld by the District Court, it would set the stage for other states to recognize what the American public has known for more than 15 years—that personal importation of safe, affordable brand-name medicines from licensed, registered pharmacies in Tier One Countries whose standards of safety or efficacy meet or exceed those of the United States has increasingly over the history of personal importation become the only safe, affordable counter to the ‘Safe Haven” provided to Pharma  in the US for the highest prescription drug prices in the Industrial World.


He mentioned only in passing that PhRMA itself had been dismissed from the suit by Judge Torresen as having no standing because there was no evidence of ‘harm’ that might have been done to PhRMA. 

He continued his disingenuous stance by noting that: ““Last night, a federal judge in Maine agreed with our position. In short, the Court invalidated the importation law in Maine by ruling that, along with specific authority vested in the Food and Drug Administration (FDA) to regulate drug importation, the ‘FDCA’s drug approval, labeling, and packaging provisions demonstrate a clear Congressional intent to tightly control prescription drug importation, - See more at:
http://www.phrma.org/media-releases/phrma-statement-on-court-ruling-on-maine-importation-law#sthash.Aqsyn1Rh.dpuf

The fact is that the FDCA reflects only the judge’s opinion that Congress indeed does have the jurisdiction to pass laws regarding the status of personal importation.  There is no reference to denying Americans access to their right to personally import medicines if Congress deems to act to allowing such access.

The ruling points out that the FDA itself has, as a matter of practice, allowed personal importation of prescription medicines as expressed in public statements, saying that it does not criminally prosecute individuals who personally imported up to 90-day supplies of their medicines.

Proponents of personal importation cite this as a de facto acceptance of personal importation.

The ruling also points out that Congress itself has passed legislation allowing personal importation with a caveat of ‘certification’ of safety by the Secretary of Health and Human Services. 

Unfortunately, this caveat has not been accompanied by Congress compelling the HHS Secretary to take steps to implement such certification, allowing instead, the option for the Secretary to exercise his or her own discretion as to whether to undertake such certification or even to offer Congress a reason for failure to act.

All of this masks the fact that brand-name medicines personally imported by American citizens from Tier One Countries are both valid and authentic medicines that of equivalent quality, safety and efficacy as their the same medicines sold in the US, at prices as much as 60 percent higher than the same medicine personally imported from a Tier One Country.

Equally, important, Mr. Murphy’s words may come back to haunt him if legislation in the form of S.122 – The Safe and Affordable Drugs from Canada Act of 2015 introduced by long-time allies of personal importation, Senators Amy Klobuchar (D-MN) and John McCain (R-AZ).

The bi-partisan legislation would allow the personal importation of brand-name medicines from Canadian sources, but, most importantly,  would require the HHS Secretary to undertake steps to implement the provisions of the bill, rather than making it an option for the Secretary.

It will be interesting to see if Mr. Murphy is as steadfast in his stand of support for Congress clear intent to control personal importation or will he join a fellow PhRMA attorney  Sarah A. Spurgeon, Assistant General Counsel of PhRMA,   who urges that FDA take action against individuals importing drugs in violation of the law, including use of its new destruction authority once FDA has finalized this proposed rule (for Section 708).”

This is a blatant appeal for the FDA to criminalize personal importation with actions against individuals for whom personal importation is a lifeline to vital medicines. 

An examination of the reactions of others who were party to the ruling indicate that they will attempt to distort in a way that Judge Torresen never intended:

·        Kenneth McCall of the Maine Pharmacy Association says, as a pharmacist, he sees first hand that cost is an issue for consumers - it's just that Maine's drug importation law is not the way to solve it.  "I think we can continue to look for better options," he says.
The obvious response is for McCall to deal first hand with an explanation of what he believes ‘better options’ might be.  We contend that Judge Torresen has laid it out—Congressional action such as S.122 setting a standard that ensures that the FDA finally fulfills the intent of Congress.

·        The problem, says Curtis Picard of the Retail Association of Maine, one of the plaintiffs in the case, is that it violated federal law. "The contention of our lawsuit was that the federal government regulates what can and cannot come into the United States," Picard says. "There's a lot of reasons for that...”
Really, Mr. Picard.  Other than the question of Federal supremacy, cite where the Judge presented any other reasons.

Interestingly, at the time of this post of this blog, PhRMA front groups such as The Center for Safe Online Pharmacies and the Alliance for Safe Online Pharmacies have not made a statement about the judgment.

Where does all this go?  The case might be appealed.  There is no guarantee it will be upheld.  Congress might pick up the cue from Judge Torresen and say, ‘Yes, we do have authority, and now, by God, we are doing to exercise it to (a) ensure that the FDA, HHS and unelected bureaucrats finally enact what we have said in many votes in the past, namely that personal importation of brand name medicines from Tier One Countries is safe—and affordable. “

It is time to call out the harmful effects of the undue influence of Pharma upon public health policy.  It is time for an RxBill of Rights on behalf of Americans.

Thursday, January 15, 2015

Safe and Affordable Drugs from Canada Act indicates reservoir of Congressional Support for Personal Importation

As one who has worked for more than 12 years on behalf of the right of Americans to purchase safe, affordable brand-name medicines from licensed, registered pharmacies in Tier One countries, whose standards of safety and efficacy meet or exceed those of the U.S., I am grateful for the long-standing support of personal importation by Senators Amy Klobuchar (D-MN) and John McCain (R-AZ).

Most recently, with their introduction and co-sponsorship of the Safe and Affordable Drugs from Canada Act, the Senators have shown that there is Congressional recognition that personal importation can be conducted safely from Tier One countries, benefiting Americans who would otherwise be denied access to their medicines simply because they cannot afford the cost of medicines in the U.S.

This legislation enables Americans wishing to engage in personal importation of medicines dispensed by Canadian pharmacies to do so under rules to be promulgated by the Secretary of Healthand Human Services. 

This is a significant mandate to the Secretary that differs from previous bills that only urged the Secretary to conduct studies on how personal importation could be made possible.

In addition, the bill, in and of itself, refutes Section 708 of the misnamed Food and Drug Administration Safety and Innovation Act (FDASIA) which would permit the seizure and destruction of personally imported safe valid prescription medicines valued at $2500 or less for reasons that have nothing to do with safety or efficacy. The FDA is now promulgating rules for Section 708 to be released in September 2015.

Since the HHS Secretary would be obligated under the Klobuchar-McCain legislation to promulgate rules to enhance personal importation , the FDA, which is an HHS agency, should ensure that the rules it promulgates for Section 708 do not  destroy valid, safe personally imported medicines for reasons that have nothing to do with safety or efficacy.

One of the primary reasons for seizures under Section 708 is ‘misbranding’. This is the description of medicine labels that, even though they meet all the labeling requirements of the countries of origin from which they were dispensed, would be subject to seizure and destruction irrespective of their efficacy or safety because there is a difference between the label of the country from which the medicine is shipped and that of the U.S.

Medicines from Canada could be disallowed simply because they are printed in both English and French. This does not affect the safety or validity of the medicine, and even though they are for the very same medicines that would be allowed by The Safe and Affordable Drugs from Canada Act, they could be disallowed by misapplication of Section 708.

Support and passage of The Safe and Affordable Drugs from Canada Act is a forceful signal to HHS, of which the FDA is an agency, that Congress recognizes that there are sources for safe personal importation of prescription medicines, and that this is to be the policy that Congress endorses, not unjustified seizures under Section 708.

Personal importation was started in the late 1990s by Elderly Americans crossing the border into Canada to fill their prescriptions. Today, large numbers of groups and municipalities across the US have entered into plans that offer choices for employees and members to purchase their medicines internationally from pharmacies in Tier One countries such as Canada, Australia, New Zealand, and The United Kingdom. 

Also, the Maine Legislature has enacted a law that allows its citizens topurchase brand name medicines from pharmacies in Canada, Australia, New Zealandand the United Kingdom.   


Now, with their co-sponsorship of this bill, Senator Klobuchar and Senators McCain continue to support the right and the ability of Americans to make responsible health care decisions.  This historic legislation will be a model for further advancing the safety, health and well-being of all Americans.  We applaud the efforts of the Senators.


Thursday, November 20, 2014

Why are Generic Drug Prices so High?

High Priced U.S. Generic Drugs Are Often More Expensive Than Brand Name Counterparts in Other Countries, According to PharmacyChecker.com


White Plains, New York — November 20, 2014 —As the Senate prepares to hold a hearing about the increasing costs of many generic drugs, PharmacyChecker.comreleased new data showing that Americans are paying more for many generics than consumers pay for their brand name counterparts in other countries. PharmacyChecker.com verifies online pharmacies and compares prescription drug prices. Some generics cost close to 20 times more than the prices of brand name equivalents available from other countries.

The hearing, "Why are Some Generic Drugs Skyrocketing in Price," will be held by the Senate Health, Education, Labor and Pensions Committee’s Subcommittee on Primary Health and Aging on Thursday at 1pm. High drug prices in America are a leading cause of prescription non-adherence. According to the Commonwealth Fund, 50 million Americans did not fill a prescription due to cost in 2012 (Source: S. R. Collins, R. Robertson, T. Garber, and M. M. Doty, "Insuring the Future: Current Trends in Health Coverage and the Effects of Implementing the Affordable Care Act", The Commonwealth Fund, April 2013).

Tod Cooperman, M.D., president of PharmacyChecker.com said: "Americans should not have to skip prescribed medications, brand or generic, due to cost. Today, as the senators seek to discover why costs are on the rise for generic, which is a critical issue, we encourage further inquiry into how Americans can afford medications they need. It might seem too good to be true, but the fact is that consumers can and do buy the brand name versions of some of these high-priced generics online from licensed pharmacies in other countries at a discount of about 90%, despite federal prohibitions."

For example, the cash price for 90 pills of the drug budesonide, which treats asthma and other lung ailments, is $1,625 at a chain pharmacy in New York City. For just $155.70, the brand version, Entocort, marketed by AstraZeneca, can be purchased online from a verified international online pharmacy – a savings of over 90%. The cash price for 90 pills of the anti-depression medication clomipramine is $900 at a U.S. pharmacy in New York City. If purchasing from a verified international online pharmacy, the brand version of clomipramine, Anafranil is $45.90 – a savings of 95%.

Foreign Brand Drug Prescription Savings vs U.S. Generic Drug1

Generic Drug Name (Brand Name)U.S. Generic Price*Foreign Brand Price+Foreign Brand SavingsAnnual Savings
Digoxin (Lanoxin) 250 mcg, 90 pills$187.00$24.3087.01%$650.80
Divalproex Sodium ER (Depakote) 500 mg, 90 pills$268.00$50.4081.19%$870.40
Pravastatin Sodium (Pravachol) 10 mg, 90 Pills$230.00$31.5086.30%$794.00
Clomipramine (Anafranil) 25 mg, 90 pills$900.00$45.9094.90%$3,416.40
Rabeprazole Sodium (Aciphex) 20 mg, 30 pills$328.00$33.9989.64%$1,176.04
Duloxetine (Cymbalta) 60 mg, 90 pills$705.00$67.5090.43%$2,550.00
Budesonide (Entocort) 3 mg, 90 pills$1,625.00$155.7090.42%$5,877.20
Amlodipine/Valsartan (Exforge) 5/160 mg, 90 pills$431.99$93.6078.33%$1,353.56
Raloxifene (Evista) 60 mg, 90 pills$584.00$88.2084.90%$1,983.20
Valsartan (Diovan) 160 mg, 90 pills$420.00$55.8086.71%$1,456.80
Average Savings:86.98%$2,012.84
1The potential savings when a consumer finds the lowest price available from a PharmacyChecker.com-approved online pharmacy vs. the price at a U.S pharmacy in Brooklyn, NY.
*U.S. generic prices at a pharmacy in Brooklyn, NY.
+Foreign brand prices found on PharmacyChecker.com. Prices for 90 pills based on 100 pill, per pill, prices.
All prices as of 11/17/2014

Higher generic drug prices are often attributed to fewer drug manufacturers competing in the marketplace. The causes of lower competition include supply interruptionswhen the FDA finds manufacturing problems, consolidation among pharmaceutical companies that make the same drug, or low profitability of certain drug products. In some cases, higher generic drug prices are simply due to arbitrary price increases by retail pharmacies.

Federal law prohibits personal drug importation under most circumstances, but the practice is generally permitted and individuals are never prosecuted, according to the FDA (See http://www.moneytalksnews.com/2013/02/01/is-it-safe-to-use-an-overseas-pharmacy/). Peer reviewed studies have demonstrated the safety of international online pharmacies verified by PharmacyChecker.com.

PharmacyChecker.com was founded by Tod Cooperman, M.D. in 2002 to help consumers safely save money on medication by identifying the lowest drug prices from reputable online pharmacies. PharmacyChecker.com independently checks the credentials of online pharmacies and pharmacy discount cards and provides free and easy online comparisons of drug prices.

For more information, contact Gabriel Levitt, Vice President, PharmacyChecker.com at 718-387-4526 or gabriel.levitt@pharmacychecker.com.

Publisher of leading websites on aging, prescription drug costs statement to U.S. Senate Subcommittee




 The following is a statement submitted as written testimony to the U.S. Senate Subcommittee on Primary Health and Aging of the Senate HELP Committee in hearings on November 20, 2014.  The statement calls for investigations into the totality of pricing practices of Pharma and the Generic Prescription manufacturers that have helped make the U.S. a 'safe haven' for the highest drug prescription drug prices in the world--all to the detriment of the health and well-being of Americans.

 
An Appeal for
A New National Strategy to Combat Exorbitant Prescription Medicine Prices in the United States
November 20, 2014


Thank you Senator Bernie Sanders and Representative Elijah Cummings, for your leadership on this important issue, and thank you Committee members for the opportunity to submit this written testimony for consideration during your hearings on the exorbitant price increases of generic prescription medicines.
You are to be commended for calling attention to the important issue of how the high costs of prescription medicines are a major driver of the country’s continuing healthcare cost crisis.
As publisher of www.TodaysSeniorsNetwork.com and http://RxforAmricanHealth.blogspot.com , I have had the opportunity to work with advocates for lower prescription drug prices for nearly 14 years.  During that time, we have documented the adverse effects to the health and well-being of Americans when they are deprived access to the health benefits of a regimen of vital medicines because they simply cannot afford them
At one time, it was believed and hoped that low-cost generic medicines would help resolve that problem.  Unfortunately, that has not proven to be the case, as too many generic manufacturers have taken advantage of the tremendous spike in brand-name medicines by major pharmaceutical manufacturers to increase the prices of their generics so much that they too are unaffordable.
And, therein, lies the root of the problem—America is perceived as a ‘safe haven’ for the highest prescription drug prices in the world.  Unfortunately for Americans,  at this time there is no tactic that will change this. 
That is why I and many others believe it is a time for a more comprehensive approach by Congress to a national strategy on all issues of prescription medicine costs and access. 
No issue stands alone.  Events in each segment of prescription medicine access and pricing are related. Each has impact upon healthcare costs and the health of Americans.
A prime example of this is the on-going onslaught by Pharma to deny millions of Americans their right to access to safe, affordable personally imported brand-name prescription medicines from licensed registered pharmacies in Tier One Countries whose standards of safety and efficacy meet or exceed those of the United States, and do so at prices as much as 60 percent less than those available in the U.S. 
For the sake of transparency, I must note that I have acted as a consultant to a number of companies in Canada who provide services to allow Americans access to purchase their medicines from such sources, as well as working with many Seniors’ advocacy groups on this issue.
Based on that first-hand experience, I encourage you to expand the scope of your investigation to examine what many advocates for personal importation of prescription medicines believe to be a comprehensive strategy by Pharma to guarantee that the U.S. is not only a ‘safe haven’ for its predatory pricing practices, as noted in the link to this blog from RxFor AmericanHealth. (http://rxforamericanhealth.blogspot.com/2014/04/the-perfect-stormpharmas-agenda-to-make.html), but to greatly reduce the options to Americans to purchase low-cost medicines, if Pharma is successful.
While at first glance, this might seem to be beyond the scope of this hearing, the fact is that if Pharma is successful in its approach to restricting personal importation, and, if the rapid rise in generics continues, the American public will have nowhere to turn to purchase affordable medicines.
Towards this end, Pharma’s strategy includes a variety of initiatives against personal importation of medicines.  These include, but are not limited to:
·        ‘Certification’ amendments imposed on the HHS Secretary to deter legislation allowing personal importation passed by the Senate;
·        Collusion between the FDA and Customs to seize safe,  personally imported prescription medicines, and to  require the individuals ordering the prescriptions to sign an ‘admission’ that they knowingly participated in an illegal act and that they would not continue to do so (fortunately, when this was called to the attention of the Senate, a bi-partisan effort  in 2007 forbade the continuation of the practice);
·        This did not discourage Pharma, which followed up with attempts to limit the freedom of the Internet by legislation such as Protect Intellectual Property Act (PIPPA) and Stop Online Pharmacy Act (SOPA), both of which were fortunately turned aside; 
·        PhRMA, the trade group for the Pharmaceutical Industry, recently joined in a law suit in Maine to overturn the will of the citizens of Maine whose legislature passed legislation to facilitate the purchase by the State’s citizens of brand-name prescription medicines from Canada, New Zealand, and the United Kingdom, but the court ruled that PhRMA had no standing and removed them from the suit, which is still awaiting a final outcome;
·        Most recently, the Country is in a position to witness a governmental agency ostensibly designed to protect the health and well-being of Americans (the FDA) actually destroying authentic brand-name medicines under Section 708 of the misnamed Food and Drug Administration Safety and Innovation Act (FDASIA) simply because the labels, which meet the requirements of the Tier One Country of Origin, are, according to the FDA, ‘mislabeled’;
·        Calls by PhRMA counsel for criminal actions against individuals personally importing their medicines, made in a statement in support of Section 708.
In closing, I applaud your continued concern in addressing the adverse impact of high prescription medicine prices upon Americans’ fiscal and physical health and well-being.  I urge you to enlarge the scope of this hearing to include the totality of the strategies employed by those who would limit access to vital medicines, leading to inevitable undesirable outcomes for the health of the American public.