FDA Needs to Increase Overseas Inspections of Pharmaceutical Manufacturers
In light of recent media reports linking deaths in Panama to drugs manufactured with improper materials, the Synthetic Organic Chemical Manufacturers Association (SOCMA) would like to draw your attention to a white paper released last fall. In the paper, SOCMA, along with the European Fine Chemicals Group (EFCG), calls for an increase in the number and scope of inspections to ensure that active pharmaceutical ingredients meet the industry’s current good manufacturing practices.
The original release is below. The full whitepaper and SOCMA’s citizen’s petition to the FDA can be found under the CPHi press conference at: http://www.socma.org/PressRoom/06_releases.htm
If you have any questions, please contact Gregory Minchak.
US AND EU TRADE GROUPS JOIN FORCES TO URGE REGULATORS TO INCREASE INSPECTIONS OF FOREIGN ACTIVE PHARMACEUTICAL INGREDIENTS
A Joint SOCMA / EFCG Position Paper discusses the need for more inspections of foreign active pharmaceutical ingredient manufacturing facilities by US and EU authorities in order to reduce patient risk from sub-par drugs, to increase national security and to level the economic playing field.
The Synthetic Organic Chemical Manufacturers Association (SOCMA) and the European Fine Chemicals Group (EFCG) released a joint position paper* entitled: “Uneven Enforcement Leads to Sub-par Drugs and National Security Risks” during a press conference held in Paris, at the CPhI Worldwide Pharmaceuticals Exhibition, on the 3rd October 2006.
The European Union and the United States both have rules in place to ensure that active pharmaceutical ingredients – or APIs – used in the manufacturing of medicines meet the pharmaceutical industry’s accepted current good manufacturing practices (GMP). However, the U.S. Food & Drug Administration (FDA) and the European Union equivalent agencies do not inspect all foreign facilities manufacturing APIs serving them. According to a 1999 FDA report, 242 manufacturers imported in the United States without being inspected. In the European Union, the situation is equally alarming. There, the EU is unable to account for the number of manufacturing facilities importing into the Union, without considerations to the number of inspections performed.
Many foreign facilities have never been inspected even though 75-80% of all API’s used by EU and US medicine manufacturers are imported. Now, a situation is developing where anyone can enter the drug market to produce generics or over-the-counter medicines and almost never go through an inspection process. “This is an appalling state of affairs considering the amount of medicines (and their precursors)
imported into the United States”, said Joe Acker, President of SOCMA. He continued, “The lack of inspections could mean a large number of unsafe medicines. On top of it all, less enforcement equates to less regulation and provides foreign firms a competitive advantage over US and EU firms that follow the rules.”
Guy Villax, Chairman of EFCG’s Pharmaceuticals Business Committee agrees and added, “Recently a group of Members of the European Parliament expressed their concern by tabling a Written Declaration requesting the EU to make inspections of manufacturers and importers of APIs mandatory to ensure higher safety standards are met and qualified by a GMP Certificate.” He continued, “I have much sympathy for the authorities here in Europe. They are charged with the responsibility of protecting our citizen’s health but are not given enough resources to send inspectors to countries such as India and China to ensure European standards are being met.”
The concerns of foreign manufactured medicines and their precursors are magnified when one considers the additional supply risk in the event of a major sickness epidemic where most of the ingredients in a key medicine are manufactured overseas. US and EU consumers could both face long waiting lines to secure essential medicines.
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What Members Are Saying…
“Several of our facilities are involved in processes related to food and feed applications and must be certified under various initiatives. We have found that in many cases the systems we have established under the ChemSystems program serve as great building platforms for meeting the requirements for these other certifications, and as a result the approval process has been greatly simplified.”