News about Prescription Medicines

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Wednesday, August 13, 2014

Why would the FDA destroy safe, authentic medicines? They don't trust Americans' judgment? No, to protect Pharma's safe haven.



Why does the U.S. FDA believe Americans are so dumb that they can’t distinguish a ‘silk purse’ from a ‘pig’s ear’ when it comes to choosing a safe source of personally imported medicines.  Look at elements from a mailer of a bogus pharmacy selling counterfeit medicines below...would you be fooled?
The FDA believes you would, and that is why it says it is seeking to create rules under Section 708 of the misnamed Food Drug Administration Safety and Innovation Act (FDASIA) that will allow it to needlessly destroy  safe, affordable and authentic brand-name prescription medicines from licensed, registered pharmacies in Tier One Countries that have standards of safety and efficacy that meet or exceed those of the US FDA, thereby denying untold numbers of Americans access to these vital medicines at prices as much as 60 to 80 percent less than the cost of the same medicines in the U.S., all to protect Pharma’s ‘safe haven’ of the U.S. for the highest prices for prescription drug prices in the world.
What are the facts? Let's take a look at what a bogus pharmacy mailer looks like, and you decide if you are safer knowing the FDA, ostensibly designed to protect American's health is destroying authentic brand-name medicines at a time when 50 million Americans forego their medicines because they are unaffordable.
Publisher’s  Note: This bogus site comes from Russia (we have purposely removed the URL to avoid someone even mistakenly clicking through to the site).  Notice the misspelling (besst pricces).  This is a common error on such sites.  The quesiton:  Do you need the FDA to tell you this is an indication of a Bogus Pharmacy site?  You will notice continued misspellings throughout this blog.  That is because the material is exactly the way it is presented on the Russian Bogus Pharmacy mailer, and such misspelling is always a tip-off of a Bogus Pharmacy.

Let's look at the claimed 'best sellers':

Our Bestselllers! 
Text Box:  Viigara 0.38$        
 Levtirra 0.95$
 Cilaiis 1.29$
 Vigarra Sublingual 0.96$
  
 Feemale Viigarra $1.43$



Notice that all the claimed medicines are sexual performance-oriented and even those are misspelled...not a single maintenance medicine listed.
And, notice the pricing. No mention of what quantities of orders will be filled, or of the need for a valid, legitimate prescription from your Physician.
Next comes a segment, called : 

Ouur Beest Sides!
( This is apparently an attempt to convince Americans what good guys our Russian 'friends' are:)

* Lowest priices and best quality on the marrket!
* Mediical associations approoved produucts

* Worldwide shippiing, you can trrack shippiing progress
* All kind of goods in one place
* Official suppliiers* Unmarked parcel

* Gifts and discounts
* You can paay by VISA and AMEX
* 1-3 days deliivery for USA clients #NEW!
* Greater 0rder - bigger discount!

 The recent pricing crisis for medications in our country has led some policy-makers to talk of possible rationing since one specialty medicine--Solvadi from Gilead--can 'cure' Hepatitis C, the cost is prohibitive and would be more than the costs of ALL the medications sold in the US last year. (Solvadi costs $1000 per pill, the complete treatment is $80,000-100,000 estimated.)

Yet PhRMA, the trade association of the Pharmaceutical industry, justifies the cost, saying 'we' (the American public will realize savings elsewhere.  And, in so doing, we are subjected to a one-two punch in which Pharma treats us like serfs, using our tax dollars in much of their R&D, while the FDA tries to scare us to death by claiming that we cannot make intelligent, responsible health-care decisions in such matters as identifying a legitimate Tier One Country Pharmacy, so they will act on our behalf to deny our access to safe, affordable personally imported medicines.

Fortunately, you have a chance to stop this folly.  Already, several House of Representative members, and Senators have taken steps to halt funding to the FDA for the implementation of Section 708.  Others have taken steps to introduce legislation in support of personal importation.  There is almost certainly going to be an investigation of the FDA collusion with PhRMA on moves to set generic drug prices so high that it protects the 'safe haven' for the highest drug prices in the world, and, most recently, it appears there will be an investigation into the destruction of thousands of emails by the Health and Human Services exec responsible for the fiasco that was the Obamacare website roll-out.  Hopefully, this mismanagement by the HHS and its FDA operations will lead to even more in-depth investigations of just how far and how high Pharma influence on prescription prices goes.

TELL YOUR CONGRESSMAN AND SENATORS TO STOP THE FDA FROM DESTROYING PERSONALLY IMPORTED AUTHENTIC, VITAL LIFE-SUPPORTING BRAND-NAME MEDICINES FROM TIER ONE COUNTRIES BY REFUSING TO FUND SECTION 708 OF THE MISNAMED FOOD DRUG ADMINISTRATION SAFETY AND INNOVATION ACT, AND TO EXPAND INVESTIGATIONS INTO THE BREADTH AND DEPTH OF THE PHARMA INFLUENCE UPON PRESCRIPTION DRUG PRICES AND ITS COLLUSION WITH THE FDA.



    

Wednesday, July 30, 2014

PhRMA call to criminalize Americans should be issue in upcoming Congressional Elections




St. Louis, MO, July 30, 2014—A stance by the Pharmaceutical Research and Manufacturers of America (PhRMA) for the U.S. Food and Drug Administration to take action against individuals who personally import prescription medicines should be an issue in the 2014 Congressional elections says the publisher of the RxforAmericanHealth blog.

Daniel Hines, publisher of RxforAmericanHealth and TodaysSeniorsNetwork says that the submission from a PhRMA associate counsel to the FDA regarding rules promulgation for Section 708 of the Food and Drug Administration Affordability and Innovation Act (FDASIA) is yet another indication of PhRMA’s goal to ensure that the U.S. remains a “safe haven for the highest prescription medicine prices in the world.”

“This is perhaps the most blatant example of the complete disregard of the health—and rights—of American citizens,” Hines says.

Section 708—which Hines describes as a flawed piece of legislation—is designed to permit the seizure and destruction of personally imported prescription medicines from outside the U.S. valued at $2500 or less.

“The safety and authenticity of prescription medicines is something all Americans should support,” Hines continues.  “But, Section 708 will create a spectacle of the FDA destroying safe authentic brand-name medicines for such arcane reasons as ‘labeling’ even if the labels meet the requirements of the country of origin-- including Tier One countries that have standards of oversight and efficacy that meet or exceed those of the U.S., as evidenced by the FDA’s own actions in reciprocal agreements with agencies in those countries to provide oversight of ingredient manufacture, as well as Pharma’s establishment of production facilities in countries other than the U.S. “

In the PhRMA submission, Sarah A. Spurgeon, Assistant General Counsel of PhRMA, notes that the FDA has traditionally allowed a degree of discretion for personal importation, following a long-standing policy of ‘decriminalizing’ such importation, or allowing the personal importation under provisions of existing law that if a drug is unavailable in the U.S.to an American citizen, and therapy was begun in a country other than the U.S., it may be imported into the U.S. for therapeutic reasons.

Then she urges the FDA take action by requiring that  “...  the patient provides evidence that the product is intended for the continuation of treatment begun in a foreign country...” and that the FDA “...restate this sentiment in the preamble to this final rule and state that, absent meeting the criteria set forth in the PIP, FDA may 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.”

“Ms. Spurgeon’s appeal reflects what many critics have long known about the coziness of the relationship of Pharma and its front groups such as PhRMA, the Center for Safe Internet Pharmacies, the Partnership for Safe Medication, with the FDA—a relationship that has evolved to the possible destruction of authentic vital medicines that are a lifeline to millions of Americans, at a time when as many as 50 million Americans forego the health benefits of access to a regimen of adherence to needed prescriptions because of cost.

“PhRMA would make criminals of American citizens simply exercising their right to good health that would otherwise be denied them, and for whom personally imported medicines offer a safe, sensible solution.

“It is time to finally and clearly present one, undeniable fact—a medicine that is unaffordable is unavailable—and it is time, in this Election Year of 2016 to demand answers from political candidates as to where they stand on this issue.”
 

Tuesday, July 29, 2014

PhRMA counsel calls for criminalization of Americans personally importing authentic meds

(PART 2 OF OUR SERIES ON WHY SECTION 708 VIOLATES DUE PROCESS OF AMERICAN CITIZENS)


In what may be most blatant example of the complete disregard of the health—and rights--of American citizens, the Associate Counsel for the Pharmaceutical Research and Manufacturers of America (PhRMA) has urged the U.S. Food and Drug Administration (FDA) to invoke criminal penalties against citizens who purchase safe, affordable brand-name prescription medicines from licensed, registered pharmacies in Tier One Countries by personal importation.
The call for prosecution was made in the trade group’s submission of comments regarding Section 708 of the Food and Drug Administration Safety and Innovation Act (FDASIA) that would create a spectacle of the FDA destroying safe authentic medicines for such arcane reasons as ‘labeling’ even if the labels meet the requirements of the country of origin-- countries that have standards of oversight and efficacy that meet or exceed those of the U.S., as evidenced by the FDA’s own actions in reciprocal agreements with agencies in those countries to provide oversight of ingredient manufacture, as well as Pharma’s establishment of production facilities in countries other than the U.S.

In the PhRMA submission, Sarah A.Spurgeon, Assistant General Counsel of PhRMA, notes that the FDA has traditionally allowed a degree of discretion for personal importation, following a long-standing policy of ‘decriminalizing’ such importation, or allowing the personal importation under provisions of existing law that if a drug is unavailable in the U.S.to an American citizen, and therapy was begun in a country other than the U.S., it may be imported into the U.S. for therapeutic reasons,
Then she urges the FDA take action by requiring that  “...  the patient provides evidence that the product is intended for the continuation of treatment begun in a foreign country...” and that the FDA “...restate this sentiment in the preamble to this final rule and state that, absent meeting the criteria set forth in the PIP, FDA may 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. (Emphasis mine).
This is clearly beyond the boundaries of the Rules Promulgation Process.  It is a reflection of the real motive of Pharma interests to make the U.S. a Safe Haven for the Highest Prescription prescription medicine prices in the world. 
Ms. Spurgeon’s appeal reflects what many critics have long known about the coziness of the relationship of Pharma and its front groups such as PhRMA, the Center for Safe Internet Pharmacies, the Partnership for Safe Medication, with the FDA—a relationship that has evolved to the possible destruction of authentic vital medicines that are a lifeline to millions of Americans, at a time when as many as 50 million Americans forego the health benefits of access to a regimen of adherence to needed prescriptions because of cost.