Monday, June 16, 2008

Will the FDA ‘farm out’ its responsibility to monitor the safety of imported pharmaceutical ingredients

(From news wire sources): U.S. health officials are pushing a plan to allow outside inspectors to monitor the safety of imported pharmaceutical ingredients, but a similar program to inspect foreign-made medical devices has largely floundered….On Monday, U.S. Food and Drug Administration Commissioner Andrew von Eschenbach requested an extra $275 million for the agency's 2009 budget, in part to allow quicker entry for imports certified by private parties. He also called on Congress to allow the FDA to more broadly use inspections done by independent, third parties.
The Bush Administration is continuing its push for privatization of another governmental responsibility. This time it’s the support of funding ‘private inspectors’ outside the FDA system to monitor the safety of imported pharmaceutical ingredients.
Ironically, the plan is presented as a ‘solution’ to the problems of the pharmaceutical industry to adequately meet its obligations to ensure the safety and efficacy of ingredients used in the manufacture of its products.
The ‘privatization’ of the FDA responsibilities to make sure pharma meets its obligations seems to be designed to relieve the pharmaceutical industry from the consequences of its failure. And, even more ironically, this is a ‘bail-out’ of an industry that has waged a vicious campaign against access to safe, affordable prescription medicines from licensed, registered pharmacies outside the United States on the grounds that there could be no guarantee of the ‘safety’ of the medicines being sold, nor the legitimacy of the pharmacies supplying the products even though they were subject to oversight and regulations that met and even exceeded those of the U.S.
Added to this is the fact that many of the Internet-based pharmacies and Pharmacy Benefit Managers had taken extraordinary steps to provide additional inspections, protections and quality controls, all with the goal of even greater safety.
The pharmaceutical industry and its mouthpiece group PhRma was well aware of this. Yet, all the while that it was deliberately lowering its standards or turning to cheaper materials thereby endangering the lives of countless Americans, all in the name of reducing costs (but not passing along the savings to the American consumer), it continued its attacks on legitimate professional businesses that offer real price relief for Americans with no sacrifice in safety or efficacy.
Senator Bernie Sanders (I-VT) has always said: “Show me the dead Canadians” when responding to the claims of pharma about ‘bogus pharmacies’ or ‘counterfeit drugs.’
The actions of pharma reflect what has really been bogus—the hypocracy of an industry reaping excessive profits, neglecting the safety of Americans and then claiming that it is protecting Americans by continuing to restrict the ability of U.S. citizens to enjoy the health benefits of affordable medicines.
Hopefully, there is a new appreciation of the facts among policy-makers. Senator Sherod Brown (D-OH) has taken a bold step—a long-overdue one, suggesting that it might be time for an investigation of the practice of pharma to admit that it turned away from its responsibilities to the American public, but used the ‘Tar Baby’ technique of attacking legitimate licensed pharmacies .

It is time for the public and policy makers to join Senator Brown in demanding answers to a number of questions. That includes those in the media, and organizations and others who have failed to meet basic standards of truthfulness and engaged in unwarranted attacks upon businesses and organizations that have worked so hard to provide a solution to problems caused by the predatory pricing of pharma. They should be called out.
Finally, it is time for the FDA to answer a basic question: If it can support privatization or faming out its duties to inspect and monitor pharmaceutical ingredients, why then can it not consider the proven success of the monitoring and oversight of those companies that have demonstrated the safety and efficacy of prescription medicines with programs that they and others have implemented? Such action can provide the basis for helping the public in determining what is bogus and what is not by empowering citizens with knowledge, not sensational or ill-founded charges.

Former Deputy Mayor of Muncie named to Governmental Liaison post by leading International Pharmacy Benefits Manager

Muncie (Special)— Phyllis J. Amburn, the former Deputy Mayor of Muncie, IN , has been named Governmental Liaison/Indiana for CanaRx Services Inc., a leading international Pharmacy Benefits Manager.

In making the announcement, G. Anthony Howard, President and CEO of CanaRx, cites Ms. Amburn’s municipal and private sector experience as a positive addition to the Company.


Ms. Amburn’s contributions to management and solutions in areas of labor relations, personnel, health care, budgets and many special projects will benefit her in this new position with CanaRx. Ms. Amburn obtained a Masters Degree in Executive Development for Public Service from Ball State University and is a native Hoosier.

“Ms. Amburn’s leadership and vision in the establishment, launch and administration of ‘MuncieMeds’ was crucial to its success for both the city and employees,” says Howard.

“This employee-sponsored voluntary program utilizes CanaRx to supply international prescription medications to city employees, their dependents and eligible retirees, who elect to participate.

"Through CanaRx, ’MuncieMeds’ participants pay zero co-payments and the city has realized well over $1 million in savings since plan inception.”

“Underfunded strained budgets are one of the biggest concerns for local governments,” says Ms. Amburn.

“I have witnessed first-hand the financial benefits provided through CanaRx and I look forward to sharing my knowledge and experience with local governments throughout Indiana. Cutting services and laying off employees are not the only solutions.” .

“CanaRx programs provide safe affordable international prescription medications to over 100 groups including six municipalities and county governments within the state of Indiana,” says Howard. “We are proud to welcome Phyllis J. Amburn to our team"

Friday, June 13, 2008

Senator Brown gets to point...drug companies use cheaper foreign, unsafe materials to save money

In what is a delightful piece of irony, United States Senator Sherrod Brown (D-OH) has taken action that has to cause anyone who has followed the campaign of false charges, misdirection and scare tactics by pharma and its allies against access by Americans to safe, affordable prescription medicines from licensed, registered pharmacies outside the United States to recognize that pharma has been caught in a case of the pot calling the kettle black.

For years, proponents of such access have battled to arm the American public with the facts--that pharmacies in other countries must meet rigid standards that meet and often exceed those of the oversight in the U.S. Added to this is the fact that these reputable pharmacies and services exhibit the highest standards of ethics and professionalism.

Still, in an attempt to protect its predatory pricing practices, the pharmaceutical industry has conducted a vicious campaign enlisting allies as diverse as a bus-riding Grandma Green who has toured the country in a John Madden-style bus to spread the pharma gospel of fear and mis-statements by college professors such as Dr. Marv Shepherd, who heads up something called the Pharmacoeconomic Studies Center at the University of Texas, but who resorts to subterfuge when called out about their pharma industry links and support, building a speaking career talking about 'counterfeit' medicines via the Internet.

Added to this is the disregard for traditional journalistic standards of media that misuse standards of free speech, hiding behind their right to make inaccurate charges, and then claim a special privilege of protection from having to report factually and accurately. One of the more recent examples is the totally false charges made by an investigative team of WISH-TV in Indianapolis against CanaRx Services, Inc., a leading international pharmacy benefits manager based in Canada. Even though CanaRx has created additional oversight practices to guarantee the safety and efficacy of prescription medicines purchased through voluntary programs with employees of local governments and has generated millions of dollars in savings for hard-pressed local governments, an 'investigative' reporter made unfounded charges of 'counterfeit drugs' in her report. When faced with demands--even the opportunity--to rectify its mistake and to correct a statement that the reporter had attempted to give CanaRx the opportunity to respond, the station instead chose to hide behind Indiana law designed supposedly to promote free discussion and debate, rather than meeting its resposibility to set the record straight.

And therein lies the basis of what makes Senator Brown's letter to Pfizer so special. It is the first time that anyone has called out the web that pharma has spun. The Senator is calling for an investigation based on earlier Pfizer testimony that it outsources 17 percent of its pharmaceutical manufacturing and acknowledgement by the FDA of the pharma trend of outsourcing to avoid drug safety regulations.

What a spectacle! Pfizer, the largest drug company in the world that has spent untold millions of dollars to prevent Americans from purchasing prescription medicines claiming concerns about safety, is using substandard ingredients to avoid oversight. Remember, we're not talking about just the manufacturing of the majority of prescription medicnes outside the U.S. (Lipitor is from Ireland,, for example), but a conscious decision by Pfizer--and others--to cut corners with no regard for the safety and efficacy of its products.

There's an old saying that when you point a finger at someone, you have three pointing back at yourself. Pfizer proves that it's still true.

Let's hope Senator Brown's call for an investigation is heeded. As part of that process, it would be appropriate to expand the scope to look at the pattern of abuse of the truth by pharma and its allies against the legitimate operations of a host of legitimate pharmacies and businesses that have dedicated themselves to providing Amerians with access to safe, affordable prescription medicines only to be victimized by reckless and false charges about their adherence to the highest standards of safety, all the while providing vast numbers of individual Americans, groups and local governments relief from the highest drug prices in the world.

To read Senator Brown's letter, click here.
Posted by Daniel Hines, publisher, TodaysSeniorsNetwork.com