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!  




Thursday, June 19, 2014

FDA to destroy legitimate medicines unless you express your outrage






Can you imagine living in a country where people die, not because treatment isn't available, but because they can't afford the high price of medicine? Unfortunately, that alarming future America may be imminent. That's why we're writing to ask for your help. Sharon from Maryland says, “My prescriptions in the U.S. are $500/month since I am unemployed and have no health insurance. The same prescriptions are $100/month from a foreign pharmacy. The ability to buy these medications at $100/month is the difference between life and death for me.
As you may know from our previous communications, the FDA is moving forward with a plan to seize and destroy personally imported medicine. In response, we’re mobilizing our supporters: please contact Sylvia Burwell, Secretary of Health & Human Services, to express your opposition.
The proposed FDA rules regarding Section 708 of the FDA Safety and Innovation Act would give government officials the authority to destroy any imported drug valued at $2,500 or less. The rules directly endanger our ability to access affordable medicine from Canada and other countries.
The public comment period regarding the proposed rules ends July 7. Before then, we must make as much noise as possible around this issue. We need to stop the destruction of safe and affordable medicine! And for that to happen, we need people to stand up and speak out!
For the sake of public health, for people like Sharon in Maryland, please email Secretary Burwell today about this issue today. Tell her your story. Make her understand that cutting off access to safe and affordable imported medicine will harm you and/or your loved ones.
Sincerely,
Lee J. Graczyk
RxRights Lead Organizer