July 7, 2014

Are Prescription Drugs the Next big Category for Kosher Certifiers?

NEW YORK — The news that the Orthodox Union (OU) has granted kosher certification to Pfizer’s Elelyso (taliglucerase alfa) for injection, has prompted the question as to whether prescription drugs is the next big category to opt for kosher certification. The debate as to whether prescription drugs requires kosher certification is not new as some rabbis have argued that anything that is ingested should be certified as kosher save for life-saving drugs. There have been many articles in the Orthodox press in Israel as to whether prescription medications as a rule should require kosher certification. 

The Star-K website points out some of the objectionable ingredients such as capsules made with gelatin. Many over-the-counter medications now routinely feature certification as do cosmetics. The whole issue takes on an added dimension for Passover as many of the ingredients may be chametz. In the latest development, the OU certified Elelyso, an enzyme replacement therapy (ERT) for the long-term treatment of adults with a confirmed diagnosis of Type 1 Gaucher disease. Elelyso is the first prescription medication to be certified kosher by the OU, a milestone for the brand which was approved by the U.S. Food and Drug Administration (FDA) in May 2012. 

“Type 1 Gaucher disease is a rare disease, most frequently found among individuals of Ashkenazi Jewish descent, which has a significant impact on patients and their families,” said Rory O’Connor, Pfizer’s senior vice president, head of Global Medical Affairs, Innovative Pharma Business. “This certification reflects Pfizer’s commitment to all patients suffering from Type 1 Gaucher disease.” The OU inspected the Protalix Biotherapeutics manufacturing facility in Israel in which Elelyso is produced to ensure that the treatment met all applicable qualifications. The criteria were met due to Protalix’s innovative and proprietary manufacturing system which uses genetically engineered carrot cells grown in a simple solution of water, plant extracts, sugar, and a mixture of vitamins and minerals to produce Elelyso.