Sunday, April 27, 2014

The Perfect Storm—Pharma’s Agenda to make the US into a Safe Haven for Predatory Pricing Practices by an denying American’s Access to Personally Imported Safe Affordable Prescription Medicines


Since the late 1990s, Americans have sought relief from paying the highest prescription medicine prices in the world by turning first to Canadian pharmacies and later to licensed registered pharmacies in other countries to provide them access to safe, affordable prescription medicines.

Immediately Pharma recognized the threat to its ability to continue to reap extraordinary profits by charging prices for its products that were as much as 60 to 80 percent higher than the same medicines Americans were able to procure primarily via the Internet and other sources.

An identification arose in the public’s mind of the issue primarily based upon a Canadian Internet pharmacy relationship, although other business models quickly arose to meet the requirement of groups and organizations acting on behalf of their members and associates to provide them with similar access, and for years, Americans living close to the Canadian border had traveled into Canada to purchase their medicines.

Over the past 15 years or so, Pharma has developed a series of attacks against personal importation that have been characterized by a singular approach to a particular issue at a given time.

Some example include:

o    Challenges to the safety and veracity of internet-based pharmacies;
o   Challenges to the safety and efficacy of even brand-name prescriptions from Tier One countries and produced by Pharma manufacturers themselves by acting in collusion with the FDA and other U.S. governmental agencies to seize those very medicines manufactured by the Pharma members themselves;
o   Attacks upon other business models similar to what would be described in the US as PBM-like services, a reflection of the growing recognition by American businesses and organization of the savings made possible by personal importation;
o   Establishing a number of front groups staffed by highly paid staff and/or consultants;
o   Attempts to co-opt the premise of intellectual property by seeking to control copyrights beyond their intended purpose (SOPA,PIPA), and to seek establishment of rules that would extend into other elements of our society such as free speech, the role of the Internet, and challenges to the proven safe record of personal importation ;
o   Continuing seizures of valid prescriptions imported into the US, and even one failed effort to force patient/clients to cede their 5th Amendment rights against self-incrimination (the 2007 FDA-Customs Collusion);
o   Alliances with other groups such as Pharmacy Boards, State Attorneys General, etc. to engage in actions to portray personal importation as aiding the rise of bogus pharmacies producing and dispensing counterfeit and unsafe medicines, and, in so doing, identifying legitimate and safe pharmacies from outside the US as not only illegally engaged in dispensing medicines, that cannot be verified for safety and efficacy.

As noted, virtually all of these and other efforts have been virtually singular in nature, arising independently with no coordination with one or more of the other activities.
As a result, even though proponents of personal importation have been outnumbered, lacking the extensive funding and the Congressional contacts of Pharma and its allies, we have successful turned back Pharma efforts in each of these areas.

That has changed.

The Perfect Storm Examined

Simply put, Pharma and its allies have altered their strategy to launch an all-out push to attack the vulnerabilities.

Each of the actions, taken independently would require immediate and serious attention and implementation of a strategy to protect personal importation, but cumulatively, Pharma, with its vast financial and lobbying resources, believe the actions have the potential to overwhelm the supporters of personal importation and deny Americans access to safe, affordable medicines.

It is moving on many fronts:

It seeks credibility by establishing ‘legal’ authorization to (a) define seized prescription medicines as counterfeit because they are ‘misbranded’, deemed potentially harmful to American health or are ‘unapproved’ by a quasi-governmental authority granted the private National Association of Boards of Pharmacy (NABP) through a strategy that would allow it to have control over the .PHARMACY domain name, which would give the NABP the quasi-governmental authority to determine the legitimacy of pharmacies around the world by determining who would have the right to use the .PHARMACY registration

Added to this are the continuing, and stepped-up efforts, to portray personally imported medicines as potentially bogus by lumping them with easily identifiable ‘pharmacies’ and counterfeit medicines by actions such as that of the Attorneys General of 20 states to put pressure on services such as Google to take steps to further restrict search services of ‘bogus’ pharmacies, which will almost certainly have a fallout for legitimate services.

A quick look at the list of actions that might be implemented in the remaining months of 2014 illustrates the breadth of the challenge:

o   Section 708 Rules promulgation giving FDA enforcement and prosecutorial authority for prescription medicine seizures and destruction of those medicines, coupled with letters from FDA seemingly without any direction from FDA as it delays announcement of rules promulgation and opportunity for 'stakeholder' statements.  Significantly, three separate letters are radical departures from previous letters, one going so far as to mistakenly state that Congress forbids personal importation. In the same letter, to a registered nurse who has purchased her medicines via personal importation for several years, the letter picks up bits of previous letters about the inability to determine a seized drug's ingredients.
o   State Attorneys General action with Google to restrict ‘bogus’ pharmacies’ listings;
o   Troubling indications of a ‘pre-Blitz’ seizure action reference letter by FDA that would result in untold numbers of Americans being denied access to the fiscal and health lifeline of safe, affordable personally imported prescription medicines;
o   NABP push for ownership of ICANN domain name .PHARMACY;
o   Complaint by CEO of Maine Pharmacy Association designed to claim Achilles Maine Personal Importation Law was not followed by Canadian Internet Pharmacies (action taken in November 2013, just now coming to light);
o   Continued ‘delays’ in Maine Court Decision on Pharma, Maine Board of Pharmacy law suit on Maine Personal Importation Law passed last year by the Maine Legislature allowing Maine citizens to purchase personally imported prescription medicines from the United Kingdom, Australia and New Zealand;
o   Revised FDA letter, shortened, no mention of 90-day supply provision found in previous letters;
o   An attitude inside the Beltway by elected Senators and Representatives who are beneficiaries of huge donations from Pharma interests that is described as a ‘By Invitation Only’ attitude.  The BIO-approach limits the opportunity for advocates of personal importation to testify before Congressional hearings on issues that affect the role of personal importation while including only Pharma interests spokespersons.
o   Trans-Pacific Trade Talks being held in secret, apparently language being dictated in large part by Pharma, an attempt to gain intellectual property rights denied in unsuccessful PIPA, SOPA strategy through likely ‘fast track’ vote. Reportedly, opposition is growing to the Pact, most notably in Australia.


SUMMARY

The conclusion is that whereas previous Pharma efforts had been characterized as admittedly potentially harmful, they were ‘individual’ in nature and lacked what can be determined in the present circumstance to be ‘cumulative’.

The current Pharma effort on a number of fronts reflects a comprehensive, coordinated strategy that by its breadth threatens the health and fiscal interests of the American patient/client for who personal importation has provided a lifeline to vital medicines. The result Pharma seeks is the removal of the ability of Americans to engage in personal importation of their prescription medicines, resulting in a barren landscape which will allow it (Pharma) to act virtually unchecked in its pricing practices, free of the competitive pressure offered by personal importation.

Pharma has attempted to claim that access to prescription drugs is not the issue it once was because of claimed savings in medical expenses and wide-spread availability of prescription medicines. 

The fact is that medical costs are increasing, as are the costs of Generic medicines, indicating that Pharma will have a longer-term strategy to gain   control of Generics, thus creating a barren landscape in which Americans continue to pay not only the highest prices in the industrialized world, but will increase the number of Americans not being able to follow a prescribed regimen of taking vital medicines.

This will result in reduced heath and well-being of untold numbers of Americans, as well as the increased cost of medical care for an aging population that will be more susceptible to disease, but are not old enough for programs such as Medicare Part D.

The solution?  2014 is an election year.  All 435 seats of the House of Representatives are ‘open’, The control of the Senate is a goal of both political parties.

It is an opportunity for Americans to ‘call out’ candidates to take a stand against the special interests of Pharma, and to issue their own ‘invitation’ in the form of a ballot on Election Day.



Tuesday, April 8, 2014

Proposed Section 708 Rules Promulgation On Seizures of imported medicines nears; Support petition to prevent unwarranted seizures, Denial of lifeline of vital medicines to Americans

One of the most potentially troublesome portions of S. 3187 (FDA Safety and Innovation Act)  is Section 708 regarding the handling and disposition of imported prescription medicines which,  under the authorization of the Secretary of Health and Human Services (HHS),  seized medicines determined to be counterfeit, bogus, misbranded or of potential harm to the health of American citizens, and determined to have a value of $2500 or less, may be destroyed by the agency making the seizure.

The rules promulgation process is nearing completion.  After the rules are presented for review and comment, there will be a 60-day period for stakeholders, including TodaysSeniorsNetwork and RxforAmericanHealth.blogspot.com, acting with other advocates of personal importation  on behalf of the more than one million Americans for whom personal importation provides a lifeline to vital drugs, to comment to urge rules that  protect their continued access to these safe, affordable medicines.

We anticipate that we will be a part of  a broad community of support, an indication of which is a petition that was recently launched by Dr. Stephen Barrett, a North Carolina physician who purchases his personal medications from an Internet Pharmacy.

Dr. Barrett’s Petition urges HHS Secretary Kathleen Sebelius to fully consider the potential harmful impact to the health of Americans by the unwarranted seizure and destruction of medicines that are safe and present no threat to Americans’ health.

We are heartened by Dr. Barrett’s concern about the potentially harmful outcome of the misapplication of any rules that might eventually emerge after stakeholders have the opportunity to be included In the development of the final rules and their implementation, and are pleased to preset the following information for your consideration and support.