The publisher of RxforAmericanHealth says that it is time for Congress to form a Congressional Caucus to support recently introduced legislative proposals on behalf of the personal importation of safe, affordable prescription medicines, and to act as a watchdog to prevent the potential of abuse by the Food and Drug Administration of Section 708 of the Food and Drug Administration Safety Innovation Act (FDASIA) with the unwarranted destruction of valid, safe medicines personally imported by Americans.
Daniel Hines, publisher of RxforAmericanHealth and TodaysSeniorsNetwork, notes that there is a reservoir of support in the US Congress for the proven safety and efficacy of personal importation. He cites the introduction of S.122, The Safe and Affordable Medicines from Canada Act by Senators John McCain (R-AZ) and Amy Klobuchar (D-MN) with co-sponsors Senators Charles Grassley (R-IA) and Senator Sheldon Whitehouse (D-RI), and HR.2228, the companion bill of the same name in the House of Representatives, introduced by Representative Chellie Pingree (R-ME1) and co-sponsored by Representative Dana Rohrabacher (R-CA48).
“The introduction of the two bills is encouraging since it is a logical extension of a ruling by a Federal Circuit Court in Maine.” Hines says.
“While overturning a state-passed law that extended a long-standing practice of Maine citizens of personally importing prescription medicines to include Canada, Australia, New Zealand and The United Kingdom, the Court did not suggest that personal importation was unsafe or even illegal, but was the responsibility of the US Congress,” Hines explains.
The Court ruling noted that Congress has in fact acted many times with votes of support for personal importation, that were not fully enacted because of amendments restricting importation by imposition of a ‘certification’ clause.
“Nonetheless, it is obvious that Congress is indeed empowered to enact such legislation,” Hines says.
In a blog at RxforAmericanHealth, Hines presents a list of issues that support the need for a Congressional Caucus:
- Rising prescription medicine costs that have created awareness of the harmful impact of the predatory pricing practices of Pharma upon Americans’ finances, health and well-being, and that prescription medicine costs are a major driver of health care costs;
- Taking the responsibility and opportunity created by a Maine Circuit Court ruling earlier this year that ruled that is Congress’ responsibility and is within its authority to determine how personal importation should be implemented, not unelected rules promulgators;
- The need and opportunity to act upon the ‘reservoir of good will’ towards personal importation by numerous members of Congress to the benefit of Americans;
- Pharma’s questionable pricing strategies, including but not limited to, Pay and Delay to protect generics from entering the market; Purchasing products from other companies and then raising the prices; Claiming extraordinary R&D investments when in reality a high percentage of the ‘new’ medicines are created through grants to University laboratories from the National Institute of Health, a governmental and tax-payer-funded entity;
- Acknowledging that medicine that is ‘unaffordable’ is equally indeed ‘unavailable’ causing 55 million Americans failure to adhere to their prescribed regimen of taking their medicines simply because they cannot afford them;
- The potential for FDA abuse of Section 708 of the Food Drug Administration Safety Innovation Act (FDASIA) by declaring that a drug may be consider ‘illegal’ because of a slight difference in labeling even though it is a perfectly safe, valid brand-name medicine that is the same as the medicine sold in the US at prices at prices as much as 60 percent higher;
- The spectacle of the FDA, ostensibly designed to protect the health and well-being of Americans seizing Americans’ medicines and the possible destruction of those medicines, creating untold bad health consequences of Americans being denied access to safe, affordable medicines
No comments:
Post a Comment