Part II: Let's just import our drugs!

Even legitimate importation of drugs by Big Pharma from their overseas manufacturing facilities has caused problems. Recall the heparin manufactured in China by Baxter Healthcare, which was contaminated by over-sulfonated chondroitin sulfate, a cheaper substance that somewhat mimics heparin’s anticoagulant activity. This was deliberate sabotage by the chemists and managers working in the Chinese plant at the expense of the public.

The FDA’s answer to counterfeit drugs and devices has been to open offices in Beijing, Guangzhou and Shanghai, other locations including India, the Middle East, Latin America and Europe. FDA employees are planning on inspecting products and developing liaisons with Chinese officials and groups. While developing liaisons with exporting governments is good, it is important to understand how ineffective it is for the FDA to go it alone on inspecting tours. According to a Reuter’s article that ran in November 2007:


"U.S. regulators inspect few foreign makers of pharmaceutical ingredients and have no accurate count of how many companies supply the American market, a watchdog arm of Congress said on Thursday. Data from the Food and Drug Administration suggest the agency inspects only 7 percent of foreign drugmakers each year, the Government Accountability Office (GAO) told lawmakers. The FDA lacks an accurate list of foreign sites subject to inspection because officials rely on conflicting databases, the GAO said. The agency cannot say how many of the overseas sites have never been visited, the GAO added.

Investigators uncovered similar problems when they reviewed the FDA’s oversight of foreign drug manufacturers in 1998, said Marcia Crosse, the GAO’s director of health-care issues. “Until FDA responds to systemic weaknesses in the management of this important program, it cannot provide the needed assurance that the drug supply reaching our citizens is appropriately scrutinized and safe,” Crosse told the House of Representatives Energy and Commerce subcommittee on oversight and investigations.

Foreign-made medicines are common in Americans’ medicine cabinets. More than 80 percent of active pharmaceutical ingredients now come from other countries, with more than half from India and China, lawmakers said.

The FDA is required to inspect U.S. drug plants every two years, but there is no set timeline for foreign facilities that supply drugs or their ingredients to the United States. One agency database lists more than 3,000 foreign sites registered to market drugs in the United States in fiscal 2007, while another put the number as high as 6,800. At the current pace, it would take the FDA 13 years to inspect each of the 3,000-plus firms once, the GAO said.

…William Hubbard, a former FDA associate commissioner, said the nation was vulnerable. “My concern is it’s only a matter of time if we don’t fix this,” Hubbard said.

FDA Commissioner Andrew von Eschenbach said the agency was “taking an aggressive approach” to adapt to the rapid globalization of drug manufacturing. Initial steps include improving computer systems and deploying FDA personnel to foreign locations for long-term assignments. “We agree we must revamp our entire strategy ... we are doing this,” von Eschenbach told the committee.

…Lawmakers will pursue legislation to give the FDA more funding for inspections and computer upgrades, said Michigan Democratic Rep. Bart Stupak, the subcommittee chairman. “I believe we have an opportunity to fix FDA’s foreign drug program before Americans are sickened or killed,” he said."


The bottom line is that the U.S. government does not have any money to waste. While we may set up offices in countries or cities where we have considerable business or there are an abundance of manufacturing facilities to facilitate trade, it is impractical to open offices everywhere. We do need to split up this task with our fellow First World countries that are also likely to be importing drugs from the same manufacturers.

We cannot waste our government’s resources putting offices in every country that might wish to export drugs to us. If foreign facilities have not been inspected and products randomly tested by us or our First World trading partners, then their products should be quarantined on entry until random samples from each shipment are tested either by the FDA or a government-authorized independent laboratory, at the expense of the exporter.

When pharmaceutical companies want to import medicines from their overseas facilities other than ones in another First World country, those facilities should be required to employ First World expats as the general managers, senior staff and QA personnel. This is not being elitist. The major problem in the Third World is the state of mind, rather than a lack of money; what is and is not acceptable there is often considerably different than in the First World. Consider Europe after the Second World War. Despite the devastation in a city like Milan, a good deal of the destruction had been repaired within seven years and commerce was functioning normally. Yet seven years after going into Iraq and hundreds of billions of dollars later, we have yet to see what resembles a First World country. We won both wars, but the success of the people in creating or recreating a First World country is vastly different. Italy was already a First World country. In the First World, people have a different set of standards and expectations for themselves and how they do business, including how they provide goods and services. In the Third World, particularly in the former communist countries I have worked in, the mentality tends to resemble a form of Ferengi capitalism. A Third World country generally does not move to a First World country in one generation. It usually takes two generations of education and seeing First World business practices for a country to move up into the First World. Until then, expat management is essential.

While we should be clear about the process and pleasant to those exporters who wish to comply, we should not let any country twist our arm by bringing politics into the situation. We should not tolerate the importation of drugs from overseas manufacturers with lower manufacturing standards than our own. This is a quality and safety issue. The FDA has a responsibility first and foremost to protect the American people.

This post is an excerpt from Healthcare Solved - Real Answers, No Politics.

Part 1: Let’s just import what we need!

This is a common attitude among the public and politicians. The American Association of Retired Persons endorses it and is organizing a grassroots campaign to support the idea. It saves all the work in trying to actually fix the problem—or does it?

It is common for retirees in Sun City, AZ, to carpool down to Mexico for their medications every month or two to save money. In my hometown of Youngstown, OH, day-trips by bus are organized to take Americans to Canada for their prescription drugs. The Internet has a proliferation of advertisements and spam e-mails for cheap prescription drugs. Why should Americans have to pay top dollar? (The answer is we shouldn’t—but don’t stop reading here.)

While it might be all right to go to another First World country to purchase medication, it is not all right to run off to the Second or Third World to do so. Before anyone thinks this unfair, consider that one of the top issues each year at the World Health Organization’s Annual Assembly is the problem of counterfeit products, whether fake, “watered” down or substituted, and the problem is increasing.

"..Increasingly easy access to sophisticated technologies such as those for printing and manufacturing, have made it more difficult for governments and other concerned parties to combat counterfeiters of medical products effectively…the extent of counterfeiting is impossible to quantify…Counterfeiting affects all medical products: from medicines and pharmaceutical ingredients to medical devices and diagnostics…Counterfeit products have been detected in most of WHO’s Member States and in all its regions. Cases have involved widely used medicines such as atorvastatin [Lipitor] and paracetamol [Tylenol], limited use medicines such as growth hormone, paclitaxal [Taxol], and filgrastim [Neupogen], erectile dysfunction medicines and medical devices such as contact lenses, condoms, surgical mesh and diagnostic test strips used by diabetic patients to monitor their blood glucose concentrations. Both expensive products and cheap ones, generic and branded products are being counterfeited with the result that they appear in community pharmacies and hospitals, as well as other less regulated settings.

Although organized crime and individuals acting alone have been associated with the manufacture and/or trade in, counterfeit medical products, in most cases the counterfeit products appear to have been internationally traded between previously unconnected groups or individuals. This fact puts an equal responsibility on importing and exporting countries.

Many factors of varying importance between Member states contribute to creating an environment where the manufacture of, and trade in, counterfeit medical products can thrive:

• Governments’ unwillingness to recognize the existence or gravity of the problem

• Inadequate legal framework and penalties

• Weak administration and coordination, with measures not focused on fighting counterfeiting

• Ineffective control of manufacturing, import and distribution of medical products

• Ineffective collaboration among bodies and institutions, such as health authorities, police, customs and the judiciary, involved in regulation, control, investigation and prosecution

• Ineffective collaboration and exchange of information between the public and private sector

• Insufficient collaboration and exchange of information

Besides the ubiquitous corruption, several other socioeconomic factors, many of which are specific to some countries, or particular areas inside a country, undermine efforts against counterfeiting:

• National drug policies that prioritize economic over public health aspects of medicine manufacturing, with the result that exporting takes priority over compliance with good manufacturing practices.

• Extreme fragmentation of distribution channels involving an unnecessarily large number of transactions, thereby increasing the opportunities for counterfeiters to infiltrate the normal distribution system

• Existence of “extraterritorial” trade zones which largely escape from regulatory and enforcement oversight and goods and their accompanying documentation can be manipulated

• Inadequate access to health services and reliable pharmaceutical supply channels that creates opportunities for “informal operators” who establish “informal supply systems” purportedly to meet populations’ real needs

• Absence of or insufficient social security coverage in countries that do not regulate prices; the resulting search by patients for better prices often leads to fierce competition among vendors and opens opportunities for counterfeiters who can offer unbeatable prices

• Illiteracy and poverty, which puts patients at a particular disadvantage

• Unregulated Internet trade, where unscrupulous sellers can hide their identity and the true origin of traded medical products

• Third-party manufacturing, which, if not properly and carefully supervised, may lead to the unauthorized use of manufacturing techniques and packaging materials." [ Counterfeit medical products. Report by the Secretariat – WHO. 61st World Health Assembly. Provisional agenda item 11.13, April 7, 2008]

This post is an excerpt from Healthcare Solved - Real Answers, No Politics.