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!
not Pharma Profits!
