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Wednesday, March 26

Cross-Industry Collaboration toward Common Standards – Feasible, Fallacy or are we all on Drugs?

by Kevin O'Donnell on Wed 26 Mar 2008 03:54 PM CDT

This was a hot topic of discussion at the IATA 2008 World Cargo Symposium Pharmaceutical Track, held in Rome, Italy a few weeks ago. The ninety minute discussion was moderated by Rafik H. Bishara, PhD., Chair of the Pharmaceutical Cold Chain Interest Group of the Parenteral Drug Association (PCCIG –PDA) and included some heavy-hitters in the industry:

Ingo Ocklenburg, Manager Strategic Sourcing of Distribution & Logistics, Bayer Healthcare AG;

Stephane Lemaire, Pharma Industry Director, Air France / KLM;

David Bang, CEO LifeConex;

Shirley Ann Feld, Assistant Director Industrial Quality & Compliance, Supply Chain, Sanofi-Aventis Pharma, GmbH, and Chair PharmaLogisticsForum EU (PLF).

This was the first time these industries engaged each other in open discussion. They identified 26 key areas to address that would help to establish common standards among the airlines, freight forwarders/integrators and other service providers and pharmaceutical/biotech manufacturers. (To view, click on attachment below).

The formation of a cross-industry Time & Temperature Task Force (TTTF) under the auspices of IATA is determined to build on this dialog and offer solutions that everyone can live with in order to improve global distribution and delivery of medicines from the healthcare sector.

The initial TTTF meeting will be hosted by British Airways April 3rd, 2008 at London's Heathrow Airport. The purpose of this meeting is to nominate and elect members to the Task Force, carve out initiatives and establish deliverables.

The International Air Transport Association (IATA) is seeking nominations from qualified individuals from the pharmaceutical and biotech industries to participate in the Time & Temperature Task Force. Participation would include involvement in a working group and monthly conference call availability.

(Winners need not be present at the London meeting to be nominated or elected)

For Terms of Reference and more information on the TTTF, you can contact Eric Raemdonck, Secretary of the Live Animals & Perishables Board at RAEMDONCKE@iata.org

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Thursday, March 20

FDA To Establish Presence in China

by Kevin O'Donnell on Thu 20 Mar 2008 10:44 AM CDT

From PharmaTechnologist.com:

The US Food and Drug Administration (FDA) has alerted the media that it has taken a significant step forward in its plans to establish a presence on the ground in China.

The agency said it has been granted approval from the US State Department to establish eight full-time, permanent FDA positions at US diplomatic posts in China over the next 18 months, pending authorisation from the Chinese government.

In addition to this, the watchdog announced it will also be hiring five local Chinese nationals to work with the new FDA staff at the US Embassy in Beijing and the US Consulates General in Shanghai and Guangzhou.

The move is part of its "Beyond our Borders" initiative, which aims to build stronger cooperative relationships with the FDA's counterpart agencies around the world and enhanced technical cooperation with foreign regulators, as the globalisation trend intensifies.

"The permanent overseas offices in China will also allow greater access for inspections and greater interactions with manufacturers to help assure that products that are shipped to the United States meet US standards for safety and manufacturing quality," said Murray Lumpkin, deputy commissioner for International and Special Programs, FDA.

Establishing a presence on the ground in China in particular has become crucial for the agency, as the country has been at the centre of a string of numerous consumer safety breaches of late and the FDA has been criticised over its lack of oversight over the quality of the escalating number of food and drug imports reaching US shores.

For example, since 1992, the agency had witnessed a 400 per cent increase in the number of foreign establishments named in generic drug marketing applications.

The FDA lacks the resources to inspect a meaningful proportion of products when they arrive at the more than 150 US ports of entry - the agency said that although FDA inspectors review 100 percent of entry documents, they physically inspect less than one percent of all imports.
Meanwhile, China's State Food and Drug Administration (SFDA) has said that while it does enforce its own strict controls on the chemicals used in pharmaceuticals, "safeguarding the legality, quality and safety of active pharmaceutical ingredients (APIs)" is ultimately the responsibility of the importing country.

China is a major supplier of foreign-made drug products entering the US. The country's 714 drug-producing establishments made up 22 per cent of all foreign facilities eligible for FDA inspection in 2007. But the agency conducted only 13 inspections in China that year, representing just 4 per cent of all inspections outside the US.

There are also thought to be many other unregistered facilities in China supplying material to the US but flying under the watchdog's radar - if a company is registered as a chemical manufacturer and not a pharmaceutical company, but still supplies chemicals to the pharmaceutical industry, and this is believed to be not uncommon, then the manufacturer is not subject to SFDA inspection and approval.

A very recent example of this is the ongoing safety scare over Baxter's blood-thinning drug heparin. Production of the drug in multi-dose vials was suspended after heparin was linked to four deaths and 350 reports of severe allergic reactions in the US.

It subsequently emerged that some of the active pharmaceutical ingredient (API) for heparin was sourced from the Changzhou SPL plant in China, which the FDA had never inspected. The FDA had apparently inspected the wrong facility, details of which were then entered into the agency's database.

Meanwhile, the SFDA had never inspected the Chinese company involved either, as it was listed as a chemicals company and not a pharmaceutical company and was not registered with the agency as a heparin supplier.

"Along with the important Memoranda of Agreement signed with two FDA counterpart Chinese agencies, our efforts to fill permanent FDA positions in China are a significant step toward ensuring access to safe food, drugs, and medical devices in the global market", said Lumpkin.

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