TRANSITION 1 The focus shifts from drug efficacy to drug safety and quality.
A different aspect of drug safety was raised in the context of the importation issue. In an effort to save money, states enacted legislation that permitted drugs to be imported from Canada and other countries. The counter-argument is that such imports will cause the US drug supply to be suspect from a quality and safety standpoint.
Thus, the industry now finds itself in a position where it must continue to tout the value of its products and defend its pricing, but also the safety and quality of its products. Further, it must prove that it can be trusted to present a balanced picture of a drug's true benefits and risks. These are new messages for a new era.
TRANSITION 2 Full disclosure is a must in the new environment, a change from keeping underlying data supporting pharmaceutical safety and efficacy secret.
Until recently, companies could selectively disclose data. Human nature and business instincts prevailed—positive data were published, negative data were not.
The new paradigm, stimulated by litigation instigated by the New York Attorney General Elliott Spitzer against GlaxoSmithKline, demands full disclosure of all studies. Companies now have websites that promise to post both positive and negative studies, as well as ongoing research. The FDA-approved labeling no longer is the best and only resource for information about the nuances of a product's safety and effectiveness profile. Each physician and ultimately each patient now has access to the same data that FDA reviews in writing the labeling.