The US Food and Drug Administration’s transparency task force promises to raise questions about why certain manufacturer information on drug products is kept secret. At the top of the list are clinical trial data and drug-safety information that disclosure advocates believe may contain important information about drug risks and adverse events. And even though more clinical trial information is being posted on the ClinicalTrials.gov website, critics say that such summary data are not enough.
Deputy FDA Director Joshua Sharfstein acknowledged in a press briefing that some proprietary information—the formula for making a certain pill, for example—may remain confidential. He also conceded that concerns about patient privacy and other issues may limit full data transparency. But this initiative clearly opens the door to broader disclosure of records that manufacturers regard as private property. Unpublished clinical and preclinical studies, product formulations, and manufacturing data have long been considered trade secrets, and pharmaceutical companies are likely to mount a stiff defense of the rules and laws that protect their rights.
FDA may have more leeway to expand transparency about its own decisions and regulatory actions. The agency currently announces product approvals, but not when it turns down an application. And it’s up to manufacturers to disclose when they file an application or withdraw a submission. Margaret Hamburg, FDA commissioner, told reporters that she wants to address complaints that FDA is a “block box” by clarifying agency processes. Agency decisions often have good explanations, and Hamburg would like to see what information could be made available to avoid confusion and criticism.
FDA will begin its transparency review with a public meeting, and Hamburg expects a report by year’s end that will describe what additional information the agency can release on its own and what changes require new regulations or Congressional action. The pendulum clearly is swinging towards the transparency side, and everyone is watching to see whether it swings too far.
Pharmaceutical Technology has added FDA’s transparency blog to its own blogroll.