Biopharma Business

The potential for harmful chemicals to be extracted from packaging materials that pose a risk to patients has spurred regulatory authorities to establish guidelines for extractable and leachable (E&L) testing for primary drug packaging materials. Drug licence holders must establish programmes that effectively assess and test these contamination risks. In 1999, following the introduction of the asthma drug salmeterol in the UK, three cases of respiratory arrest occurred shortly after patients started taking the drug; and, at about the same time, the United Kingdom Committee on the Safety of Medicines reported 26 cases of deterioration in asthma soon after the introduction of long-acting beta-agonists. In 2005, a paper published in the medical journal Kidney International reported on the increased incidence of pure red cell aplasia with an Eprex formulation in uncoated rubber stopper syringes.

Recently, other issues have been highlighted in the media, such as concerns regarding the safety of phthalates, and there were reports of a postponement of the MMR vaccination of babies in some parts of the Netherlands because of fears about glue leaking from needles. The regulatory authorities have not been slow to react to these concerns and the very real risks of product contamination from E&Ls, the US having enacted E&L legislation under the Federal, Food, Drug & Cosmetic Act (FFDCA), and the EU having recently introduced decentralised and mutual recognition procedures for the evaluation of E&L safety risks.