- · Her plan calls for implementation when drug prices are ‘threatening’ the health of Americans because the drugs are unavailable due to their price. This should be extended to unaffordable ‘maintenance’ brand-name drugs that millions of Americans rely upon as a vital link to their health and well-being;
- · While her plan calls for ‘temporary,’ personal importation, if she were elected, she likely would have to use executive orders to implement and utilize such a ‘temporary’ role for importation. That’s why Congress should end its seemingly endless delays, investigations, statements, and business as usual;
- · Her stance clearly calls upon medicines from what can only be construed as a reliance upon Tier One Countries with proven standards of safety and efficacy that meet of extend those of the U.S.;
- · She points out that the Food and Drug Administration has in the past allowed such ‘emergency’ importation;
- · This is a tacit admission and recognition of the fact that, contrary to repeated claims of the Food and Drug Administration regarding personal importation that :
- o It is indeed possible to monitor and certify the safety, authenticity of brand name medicines ‘imported’ to the U.S.;
Tuesday, September 6, 2016
Clinton recommendations to end Pharma pricing abuses, including a role for ‘emergency’ importation of medicines, proving that the FDA, Pharma and Pharma supporters have misled the American Public on the ability to ascertain the authenticity and safety of personally imported medicines
by Daniel Hines, Publisher
Hillary Clinton’s strategy to deal with lowering prescription prices is the most comprehensive approach employing several action steps that have previously been introduced only as individual actions reliant upon reaction to a series of Pharma price abuses.
As such, it represents hopefully an end to Pharma’s actions that have been based on its confidence that it can charge what the traffic will bear, thumbing its Collective nose at Congress and the American public.
Most importantly, its stand on imported medicines proves that the Food and Drug Administration Pharma and Pharma supporters have misled the American Public on the ability to ascertain the authenticity and safety of personally imported medicines!
While GOP Candidate Donald Trump has indicated his support for strategies to lower prescription drug costs, he has yet to come forth with specifics to lower prescription drug prices.
Also, while the Democratic Party Platform specifically endorsed and supported a role for Personal Importation, an end-to-pay to delay and other steps to lower prescription drug prices, the GOP Platform had no mention of healthcare except for a call for repeal of the Affordable Care Act (ACA).
Additionally, former GOP Speaker of the House Newt Gingrich recently touted the GOP Platform as supporting ‘Pharma innovation and research and development’. Gingrich specifically attacked the role of Personal Importation of brand-name medicines from Tier One Countries, asking only that the American public adopt a ‘trust us’ attitude towards Pharma.
An examination of Ms. Clinton’s proposal is triggered by a realization of the fact that unaffordable medicines are, in and of themselves, unavailable because of their unaffordability.
At the same time, it is limited because it deals with ‘emergency-like’ crises that continue to occur with a disturbing frequency as Pharma continue its pricing abuses. That’s why it is time that the Presidential candidates take a strong stand to enact permanent—not just temporary or emergency-related incidents. Some thoughts on her plan follow:
o The fact that such ‘importation’ would have to be implemented quickly to be of benefit indicates that the FDA also is capable of such validation of the sourcing, manufacture, packaging, safety and efficacy of imported medicines, particularly since it has for years cooperated with foreign sources for ingredients' oversight, and it has worked with regulatory agencies in other countries during previous ‘emergency’ importation;
o The implementation of even a temporary importation’ program would be proof positive of the safety and efficacy of imported medicines as well as their immediate economic benefit, and, in the long-term, their favorable impact upon American’s health. The lie to claims by Pharma and the FDA that a medicine allowed to be imported from a Tier One Country cannot be validated would be repudiated. A medicine that is imported in an ‘emergency’ situation that is safe and authentic cannot become fraudulent after the ‘emergency’ is over. Simply put, when a medicine—any medicine—is unaffordable, it is unavailable, and that unavailability creates a crisis and emergency situation for the individual denied access to vital medicines;
o A ‘temporary importation’ would illustrate the contradiction of a policy that raises questions about the ‘legality’ of personal importation, since it clearly illustrates that the Federal Government is willing to consider importation as a part of a national policy to lower prescription drug costs to protect the health of Americans;
o That benefit to medicines and the right to purchase them via personal importation should be extended to the millions of Americans who are unable to afford not only their specialty medicines, but their highly important maintenance medicines—maintenance medicines that have been proven in the Rand study of enrollees in the Affordable Care Act to improve patient health and lower total drug spending;
o The Clinton plan calls for consumer involvement and representation in an oversight group to monitor and determine when price abuses by Pharma have occurred, one of the key articles of the American Rx Bill of Rights. The key to the effectiveness of such a group will be based on a determination of the members of the ‘consumer’ advocacy segment and how they will be selected. The concept is a valid approach, but only if implemented in such a fashion as to include truly representative advocacy groups that represent patients’ rights and needs;
o There is a strong emphasis in the Clinton plan on the role of generics. But, in what is can only be construed as an admission of the failure of such a previous reliance upon generics to lower drug costs because of their being co-opted for many of the price increases in the past 18 months, the Clinton plan calls for fines and penalties to be assessed against Pharma and generic industry firms that are found to profit from excessive price increases;
o The plan calls for an end to several key elements of Pharma strategies: One is pay-to-delay, a tactic to delay the introduction of generics to replace brand-name drugs scheduled to lose patent protection; another is a call for negotiating Medicare Drug prices; The plan would also call for an end to the backlog of generic applications awaiting approval at the FDA; and, in one of the most dramatic recommendations, it calls for an end to direct-to-consumer (DTC) advertising by Pharma, with the money spent on DTC being redirected to Research and Development.
If any strategy—be it that of Ms. Clinton or Candidate Trump—is to succeed, both candidates would be well-served to remember that years ago, at a press conference after a Pfizer Board meeting, then CEO Henry McKinnell commenting on remarks by Minnesota Governor Tim Pawlenty said that efforts to lower prescription prices were nothing more than “a Prairie Fire that breaks about every four years as an election issue and then burns out.’’
Such a statement shows the contempt that Pharma has long held for the American political process—a contempt based upon Pharma’s extensive lobbying and millions of dollars in campaign contributions, including to Ms. Clinton.
It is time to end the pricing abuses of Pharma and to implement policies that will lead to the health benefits that only access to safe, affordable prescription medicines can provide. Failure to do so will once again leave the rights of Americans to enjoy the benefits of good health such access can provide in the ‘ashes of yet another Prairie Fire.’