FDAnews
www.fdanews.com/articles/72484-phrma-calls-nonclinical-safety-studies-of-adjunctive-therapies-excessive

PhRMA Calls Nonclinical Safety Studies of Adjunctive Therapies Excessive

May 19, 2005

An FDA draft guidance that proposes manufacturers conduct nonclinical safety studies on drug combinations, including adjunctive therapies, is excessive and needs to be further clarified, PhRMA said in recent comments submitted to the agency.

Released in January, the draft guidance provides industry with recommendations on nonclinical safety evaluations to support the clinical study and approval of drug combinations, including fixed-dose combination products, co-packaged products and adjunctive therapies. The guidance applies to three subgroups of drug combinations: 1) combinations involving only previously marketed drugs; 2) combinations including one or more new molecular entities (NMEs) and one or more previously marketed drugs; and 3) combinations consisting of more than one NME.

While PhRMA said it generally agrees with the FDA's recommendations, it expressed concerns about the agency's definition of adjunctive therapy as it applies to nonclinical safety studies. Under the FDA's definition, "an adjunctive therapy refers to the situation in which a patient is maintained on a second drug product that is used together with the primary treatment, although the relative doses are not fixed and the drugs need not be given at the same time." PhRMA called the definition "exceedingly broad" and said it would be unrealistic for drugmakers to conduct nonclinical safety evaluations on all potential adjunctive therapy combinations.

To view PhRMA's comments, go to http://www.fda.gov/ohrms/dockets/dockets/05d0004/05d-0004-c000002-02-vol1.pdf (http://www.fda.gov/ohrms/dockets/dockets/05d0004/05d-0004-c000002-02-vol1.pdf).