March 2017 Posts

Drug Importation is Dangerous – 4 Former FDA Commissioners Advise

According to the last four administrative FDA commissioners Robert Califf, Margaret Hamburg, Andrew von Eschenbach and Mark McClellan, drug importation is a risky move despite the fact that Donald Trump and Bernie Sanders support it. This is a move that would pose great danger to consumers as the risk of exposing them to contaminated, fake or substandard drugs are high.

Two FDA in an open letter to congress raised these concerns. The letter was also posted in the Margolis center for Health Policy in Duke University. Four former FDA commissioners, two who served under the Obama regime and the other two who served under Bush signed the report.

The four commissioners acknowledged that while the move to import drugs would mean lowered medical cost especially with regard to drug access, it also meant that patients would be exposed to poor quality drugs. This would be compromising the carefully the safety standards that the country has spent so many years building. The commissioners believe that accepting to import drugs would translate to jeopardizing the health of the citizens.

According to Bernie in a motion to the senate, he claims that there should be a legislation allowing the US to import drugs from other countries preferably Canada and Europe. He claims that drugs from these countries are cheaper because of government regulations.

Even with this, the FDA commissioners in their letter warn that the global market experience has not been a good one. The availability of adulterated drugs, illegal and ineffective drugs is on the rise. In fact, this industry has become one of the most organized crimes. Accepting to import medication would mean exposing US citizens to such risks.

According to Callif, in a Friday interview, most of the online advertisers claiming to be based in Canada re actually located in South America, Russia and Eastern Europe. It is therefore impossible for consumers to know for sure what is in the drugs and where the drugs come from. In fact, there is a greater fear that consumers may never be sure if they getting what they ordered for.

Even with such legitimate concerns, supporters of drug importation brush off these safety limitations with the claim that they can be controlled. The supporters claim that the country’s drug industry is exaggerating the risks to thwart the idea of importation. Sanders claims that only FDA approved sellers will be contacted after the FDA has done a thorough investigation of the manufacturing plants.

 

Who’s to blame for drug shortages

When someone tries to do good, it seems like someone else will find a way to downgrade it, or simply find blame where none resides. The Group Purchasing Organizations (GPOs) fight to keep drug shortages diminished – however, those in the medical device community, particularly Phil Zweig, Executive Director of Physicians Against Drug Shortages (PADS), wants the GPOs to take full responsibility for the deficiency.

As for the PADS, this group has no background or understanding of the supply chain management.

Mr. Zweig has taken it upon himself to run down the respectable name of the GPO, going so far as to hold this organization blameworthy for the acceleration of the AIDS virus, not to mention the untimely demise of two U.S. attorneys. Besides this, he included two sitting U.S. Senators as conspirators in concealing extensive corruption.

According to the HSCA, the U.S. Government Accountability Office (GAO), Department of Justice, Federal Trade Commission, the U.S. Supreme Court, the 8th Circuit Court of Appeals, academia, and virtually all of America’s 7,700 hospitals conducted a thorough investigation of GPO cost savings, administrative structure, and business practices.

The HSCA goes on to mention that such organizations as the FDA, HHS, GAO, and others have discovered through investigation that the issue of drug shortages falls into the hands of the drug manufacturers who had manufacturing problems, quality control issues, and barriers to getting new suppliers online.

For some reason, it appears that Mr. Zweig not only wants academia to discover negative conclusions about the GPO but also wants academia to suffer disciplinary action by their universities.

Even though the GPO has gained naysayers, this organization is working cooperatively with hospitals, manufacturers, distributors, and others to make hospitals and their patients feel secure in receiving vital and necessary drugs.