FDA a Paper Tiger: China and the Heparin Probe

Ed Silverman on July 22nd blogs in Pharmalot about the questions being raised in Congress and within the media of the FDA’s lack of holding Chinese officials accountabile in tracking down the issue of the deadly Heparin issue that killed dozens in the US several years ago.

In this excellent blog post, Mr. Silverman highlights:

· ...how hard is the agency trying to get China to cooperate when problems arise? Not hard enough, according to a congressional probe that reveals the FDA repeatedly asked the Chinese government for help in pursuing an investigation into contaminated heparin, but was “severely hampered” by a lack of cooperation.

· You may recall that contaminated heparin made in China was linked to 81 deaths in 2007 and 2008 and the episode sparked a firestorm of criticism at the FDA for its failure to monitor medicines made there. Since then, the heparin scandal has faded from view, but the congressional probe revives the matter - and portrays the agency as a paper tiger.

· “It is shocking to find out two years after Chinese-made heparin was killing Americans, the Chinese government still has done no investigating to find out why,” Joe Barton, the top Republican on the House Energy and Commerce Committee, tells the Wall Street Journal. He and Mike Burgess, another Texas Republican who is the ranking member on the Subcommittee on Oversight & Investigations, blast the FDA for not pressing the Chinese or acting on info obtained over the past two years . The probe, by the way, comes as FDA commish Margaret Hamburg prepares for her first trip to China.

· An FDA spokeswoman tells the Journal that “there are serious limitations on what the FDA can do to pursue civil and criminal investigations in foreign countries, especially without the cooperation of the foreign government.” In a June 16 letter to the congressmen, the FDA wrote that it was “denied full access” to manufacturers of raw heparin in China.

· Chinese security authorities told a US official in Beijing in June 2008, that China wasn’t investigating the heparin episode as a criminal or administrative matter, he tells the paper.

This excellent blog brings to light the ability of the US government to properly investigate serious issues with quality, adulteration, fraud and counterfeiting with an important trading partner where a significant number consumer and health care products and their raw materials originate.

The lack of regulatory cooperation between nations is a serious concern to all within health care and its consumers.

Given the inability of the regulatory authorities to work together and properly vette and secure the global supply channels. Secure Pharma Chain believes that it is critical for all members of the global pharmaceutical supply chain to take measures to protect its inventories and brand by deploying technologies that validate the authenticity and efficacies of its products.

To read the entire Pharmalot blog, visit: http://www.pharmalot.com/2010/07/china-stymies-fda-probe-into-contaminated-heparin/#more-25075

To learn about supply chain validation solutions, visit: http://www.xstreamsystems.net/.

CRS Report for Congress: Intellectual Property Rights and International Trade

The Congressional Research Service (CRS) prepared a report on Intellectual Property Rights and International Trade. The report is authored by Shayerah Ilias and Ian F. Fergusson and was published in July 2008. There were many interesting pieces of information as it relates to the pharmaceutical supply chain and although somewhat dated the data points are very relevant as it relates to the size, scope and impact on commercial interests globally.

In the opening summary, Ilias and Fergusson wrote:

“This report provides background on intellectual property rights (IPR) and discusses the role of U.S. international trade policy in enhancing IPR protection and enforcement abroad. IPR are legal rights granted by governments to encourage innovation and creative output by ensuring that creators reap the benefits of their inventions or works and they may take the form of patents, trade secrets, copyrights, trademarks, or geographical indications. U.S. industries that rely on IPR contribute significantly to U.S. economic growth, employment, and trade with other countries. Counterfeiting and piracy in other countries may result in the loss of billions of dollars of revenue for U.S. firms as well as the loss of jobs. Responsibility for developing IPR policy, engaging in IPR-related international negotiations, and enforcing IPR laws cuts across several different U.S. Government agencies. The main structures for coordinating interagency efforts are the National Intellectual Property Law Enforcement Coordinating Council (NIPLECC) and the Strategy Targeting Organized Piracy (STOP!).”

Here are some of the interesting pieces of information contained within the CSR report as it relates to pharmaceuticals:

• Department of Homeland Security (DHS) provides data on counterfeit goods seized by category. Seizures of counterfeit pharmaceuticals increased significantly, from $2.3 million in 2006 (1% of total) to $11.1 million in 2007 (6%).


• According to U.S. customs data, pharmaceuticals accounted for only 1% of all goods seized in 2006, with a domestic value of $2.2 million. Still, there is growing concern about the vulnerability of the U.S. medicine supply and distribution chain, especially in light of recent high-profile cases about counterfeit drugs entering the United States.


• PhRMA provides annual estimates of U.S. pharmaceutical industry losses from foreign violations of data exclusivity and patent protection. In its 2007 Special 301 submission to the USTR (covering the period of October 2006 to September 2006), PhRMA contended that its member companies sustained damages totaling an estimated $21.7 million from data exclusivity and patent violations in 24 countries. Damages reported in the 2007 submission were nearly double those reported in the prior year’s submission (covering October 2005 to September 2005). While the total loss associated with IPR infringement grew, damages as a percentage of sales declined from the 2006 submission to the 2007 submission. At the time of reporting for 2008 Special 301 submissions, PhRMA was not able to provide damage estimates due to trade barriers associated with intellectual property protection and market access.


• U.S. CBP and L.A. Strategic Trade Center, “FY2006 Top IPR Commodities Seized,” November 7, 2006, [http://www.cbp.gov]. Because of the costs and resources required to conduct physical inspections, many counterfeit products escape inspection, making it difficult to determine the fraction of pirated goods caught. As a result, seizure statistics from the DHS agencies do not reflect on the overall size of the counterfeit market and total losses.

As we have said many times, XStream Systems believes in a comprehensive strategy to combat counterfeit and adulterated pharmaceuticals. XStream believes that this solution should include verification and screening of the materials inside their unit of sale containers. XStream’s XT250, using EDXRD, allows for the complete verification of the material, without opening the container or destroying/degrading the product being authenticated.

To view the CRS report, follow this link:
http://fpc.state.gov/documents/organization/109543.pdf