Hawkins stated that there are still issues that are unresolved regarding the implementation of the act which will require the knowledge and input of researchers and practitioners of healthcare economics. Representatives from the pharmaceutical industry presented their perspective on this legislation. During the development of this legislation, representatives from the pharmaceutical industry, consumer groups, the FDA and congressional staffers discussed issues with the intent of arriving at an equitable compromise. Crucial to the implementation of the law will be a collaborative effort by all parties who create and use health economic information. Pat Deverka MD, MS, Janssen Pharmaceutica, emphasized that the intent of the new legislation is to increase the flow of health economics to health care decision-makers.
Drug manufacturers are the most efficient suppliers of that health care economic information.
The new legislation, however, has the potential of being read too narrowly and thus undermining industry incentives to develop and disseminate health economic information. In addition, the FDA should allow for a wider range of evidence for substantiation, e.g. observational data and modeling. Experts in the field, including industry experts, should be consulted with regard to the implementation of a guidance. Leonard Kirchdoerfer PhD, Genentech, described the effects of the legislation on the biotechnology sector of the industry. Thus there is a great need to generate data on price justification.