FDA to apply disclosure rules to biologics

The FDA announced Friday that it will release summaries of safety and efficacy data about biologics one day prior to advisory committee meetings. In response to a lawsuit brought by consumer advocates, FDA has been releasing information about NDAs in advance of advisory committee meetings since January 2000, but it has declined to apply the policy to products regulated by the Center for Biologics Evaluation and Research (CBER). The new policy will bring CBER disclosure policies into line with those adopted last year by the Center for Drugs Evaluation and Research (CDER). The policy will come into effect at CBER advisory committee meetings convened after June 1. As with CDER meetings, BLA sponsors will be asked to submit: copies of slides to be presented at the advisory committee meeting; summary tables of safety and effectiveness data; summaries of clinical or non-clinical safety or effectiveness data and suspected adverse drug reaction data; and clinical or preclincial protocols. Sponsors will be permitted to redact specific categories of proprietary information, including product formulation and other chemistry, manufacturing, and controls information and full reports of raw clinical or preclinical data.

FDA will post on its website the sponsor package and information CBER has provided to advisory committee members, with proprietary information redacted. The agency stated that if it is "unable to post the package on its website prior to the meeting, the two packages will be made publicly available at the location of the advisory committee meeting, and the two packages will be posted on the agency website after the meeting." ...