News about Prescription Medicines

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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.

Friday, July 18, 2014

Copy of letter send to HHS Secretary Burwell about needless destruction by FDA of authentic meds



Sylvia Mathews Burwell
Secretary, Health and Human Services
The U.S. Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201

Dear Secretary Burwell:

I am writing to offer my congratulations to you on your nomination and assumption of the duties as the Secretary of Health and Human Services.

Among the many challenges you will face as Secretary will be the continuing problem of the costs of prescription medicines, an issue that forces as many as 50 million Americans to forgo adherence to a regimen of taking vital medicines because they simply cannot afford them.  (1)

This threatens the health and well-being of  huge numbers of Americans.  That is why so many individual Americans, groups, and local and state governmental entities  have turned to personal importation of brand-name prescription medicines from Tier One Countries, whose standards of safety and efficacy meet or exceed those of the U.S.

And that is why I must alert you to the potential harmful impact of rules that are being promulgated for Section 708 of the Food and Drug  Administration Safety and Innovation Act(FDASIA).  Section 708 would allow the destruction of a drug valued at $2,500 or less that has been  refused admission into the United States.

 Since there is no requirement that the FDA test the authenticity of seized medicines, we shall witness the spectacle of a governmental agency (the FDA) specifically designed to protect and promote the health and well-being of Americans instead destroying legitimate medicines at a time when millions of citizens are unable to enjoy the health benefits of access to a regimen of prescription medicines because of their high cost.

I respectfully urge you to order a delay in the implementation of Section 708—a move that is gaining support among Congress as it realizes the Section actually is contrary to  what should be the goals of the FDA.  I am including a copy of the Section 708 Rule Promulgation submission from TodaysSeniorsNetwork.com and RxforAmerican Health blog as background for your review and consideration.

Sincerely,

Daniel Hines

Thursday, July 17, 2014

Publisher of websites on aging, Rx issues alerts HHS Secretary to FDA destruction of Americans’ authentic prescription meds


The publisher of websites about aging and prescription medicine issues has sent a letter to Sylvia Mathews Burwell, recently approved as Secretary of Health and Human Services (HHS) alerting her that unless  she takes action, Americans may witness the spectacle of a governmental agency (the FDA) specifically designed to protect and promote the health and well-being of Americans destroying personally imported legitimate brand-name medicines at a time when millions of citizens are unable to enjoy the health benefits of access to a regimen of prescription medicines because of their high cost.

Daniel Hines,  Publisher of www.TodaysSeniorsNetwork.com and http://RxforAmericanHealth.blogpot.com, said he sent the letter in response to the rules promulgation process of the FDA for Section 708 of the Food and Drug Administration Safety and Innovation Act (FDASIA) which would allow the destruction of a drug valued at $2,500 or less that has been refused admission into the United States.

“Since there is no requirement that the FDA test the authenticity of seized medicines, we can be certain that authentic, safe affordable prescription brand-name medicines personally imported by U.S. citizens from licensed, registered pharmacies in  Tier One Countries, whose standards of safety and efficacy meet of exceed those of the U.S.,  being destroyed merely because of a difference in labels,” Hines notes.

“This has been a goal of Pharma and its allied front groups for more than 15 years during which time the continued predatory pricing practices of Pharma have made the U.S. into a safe haven for the highest prescription drug prices in the world.

“I respectfully urge the Secretary to order a delay in the implementation of Section 708—a move that is gaining support among Congress as it realizes the Section actually is contrary to  what should be the goals of the FDA,” Hines continues.  (To Read the Letter, go to http://rxforamericanhealth.blogspot.com/2014/07/copy-of-letter-send-to-hhs-secretary.html )

Thursday, June 26, 2014

Section 708 threatens American Health, Due Process (Part 1)


Call to Action: Alert your Congressman and Senator to the risks of Section 708 rules to allow the seizure and destruction of safe, affordable, brand-name prescription medicines, and why it could affect Americans' Health by disrupting a lifeline to vital medicines—all to ensure profits for the Pharmaceutical Industry!


  • The Food  and  Drug Administration (FDA ) is proposing a regulation—Section 708—to implement its authority to destroy a drug  valued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation) that  has been  refused admission into  the United States under the Federal Food,  Drug, and  Cosmetic Act.
  • · The FDA claims the proposed rule would provide the owner or consignee of a drug  that  has been  refused admission into  the United States with (1) written notice that  FDA intends to destroy the drug  and  (2) notice and offer an opportunity to present testimony to the Agency before  the drug  is destroyed.
  • · The FDA and the Pharmaceutical Industry claim that this act is designed to deter illegal, counterfeit prescription medicines into the U.S.
  • · Actually, the purpose is to cripple and destroy the right of Americans to engage in the personal importation of safe, affordable brand-name prescription medicines from licensed, registered pharmacies from Tier One pharmacies outside the U.S.—countries whose standards of safety and efficacy meet or exceed those of the U.S. FDA.
  • · This has been a goal of Pharma and its allied front groups for more than 15 years during which time the continued predatory pricing practices of Pharma have made the U.S. into a safe haven for the highest prescription drug prices in the world.
  • · As a result, millions of Americans have exercised their right to make medical decisions and turned to sources outside the U.S. to provide their lifeline of vital prescription medicines.
· Section 708 is a flawed approach to guarantee product safety of prescription medicines.

  • · The FDA says it estimates that there would be slightly more than 12,000 destructions of medicines each year, which it describes as a ‘net social benefit’ of between $228,000 and $616,000, making one wonder how the benefit was created and what value the FDA places on its claims of saving American lives.
  • · Significantly,  the FDA notes that the seizures will “benefit firms through increases in sales, brand value, and  investment in research and  development if the destroyed drug  is a counterfeit or an otherwise falsified version of an approved drug” meaning the Pharmaceutical industry which already enjoys outrageous profitability at the expense of the American public will cement its grip on the U.S. as a 'Safe Haven' for the highest drug prices in the world.


It’s time to demand Congress act to protect Americans’ Health,
not Pharma Profits!