Groups to FDA: Get toxic chemicals away from drugs and biologic products

"Christine Hines"Public Citizen recently joined with other consumer and patient groups in a letter urging the U.S. Food and Drug Administration to ban phthalates from drugs and biologic products.

Phthalates are a family of chemicals known as “plasticizers” that are used in consumer and pharmaceutical products. For example, they are used to soften plastics – like those used in products such as baby teething rings and pacifiers. These chemicals, including dibutyl phthalate (DBP) and di(2-ethylhexyl) phthalate (DEHP), have been linked to cancer, as well as developmental and reproductive defects.

Phthalates are being phased out of consumer products – a 2008 federal law banned these phthalates in children’s products. The European Commission and the Environmental Protection Agency also have noted the health risks of the chemicals.  The EPA said it is concerned about phthalates because of “their toxicity and the evidence of pervasive human and environmental exposure to these chemicals.”

The organizations’ letter to the FDA was a response to the FDA’s draft guidance to industry, which recommended that the pharmaceutical industry avoid the use of dibutyl phthalate (DBP) and di(2-ethylhexyl) phthalate (DEHP) in their drug and biologic products.

While the draft guidance was a step in the right direction, the FDA should go further, especially since safer alternatives are available, the organizations said in the letter.

Due to the serious health risks, the FDA should ban the use of phthalates in packaging materials. These chemicals can leach from the packages into drug and biologic products.  As the letter said, “A number of research studies reveal poor health and behavioral outcomes for children exposed to phthalates. For example, there is an association between children’s exposure to phthalates and the risk of asthma, allergies and bronchial obstruction.”

Banning DBP and DEHP would help to reduce the “real-world, cumulative negative effects of phthalates in the health of children and adults.”

The FDA must take this next logical step.