In the past, the Food and Drug Administration (FDA) has been criticized as a “black box that makes important decisions without explaining them.” Margaret Hamburg, a former FDA Commissioner, made this comment in response to current calls for the FDA to provide more “transparency” to the public on how and why it makes decisions. However, the FDA does not seem to be moving in that direction, or taking any of these criticisms seriously.
In fact, last week the FDA went against an advisory panel’s strong recommendation and didn’t approve a rivaroxaban Johnson & Johnson anti-clotting drug. Seemingly, the FDA provided no reasoning or adequate explanation for its decision, leaving industry and consumers left to make assumptions.
As a result, the FDA announced today the formation of an internal task force that will look at what information to provide to public and what to continue to keep behind a veil.
The task force will be chaired by Principal Deputy Commissioner Joshua Sharfstein, M.D., and will include center directors, the associate commissioner for regulatory affairs, chief scientist, and the chief counsel.
The Task Force will:
- Seek public input on issues related to transparency;
- Recommend ways that the agency can better explain its operations compatible with the appropriate protection of confidential information;
- Identify information the FDA should provide about specific agency operations and activities, including enforcement actions and product approvals;
- Identify problems and barriers, both internal and external, to providing useful and understandable information about FDA activities and decision-making to the public;
- Identify appropriate tools and new technologies for informing the public;
- Recommend changes to the FDA’s current operations, including internal policies and guidance, to improve the agency’s ability to provide information to the public in a timely and effective manner;
- Recommend legislative or regulatory changes, if appropriate, to improve the FDA’s ability to provide information to the public; and
- Submit a written report to the commissioner on the Transparency Task Force’s findings and recommendations.
The Task Force will be holding two public meetings, one on June 24 and the second in the fall, with a report due near the end of the year. The FDA will also look to solicit feedback from the public and stakeholders during the process.
The Wall Street Journal has also predicted that this FDA task force will cover issues topics such as clinical-trial data and details on decisions about recalls and drug approvals.
Consequently, many of these areas concern complex legal issues involving protection of trade secrets and intellectual property, as the New York Times noted in a story this morning.
Further details from the Wall Street Journal revealed that some of FDA’s leaders are “approaching [the issue of transparency] from the perspective that they want to see how the agency is approaching what information it makes available to the public.”
FDA Principal Deputy Commissioner Joshua Sharfstein said. “In many cases the agency has a very good explanation — or has an explanation — and you don’t necessarily hear that explanation very clearly.”
Interestingly, the issue of transparency within the FDA could not have come at a more crucial time.
Consequently, industry, consumers, and physicians need to attend these meetings and offer input before more mistakes and decisions are made, and then become “classified.”
At the very minimum, the FDA needs to provide guidelines for how it makes its decisions not to release information concerning drugs, and the necessary criteria appropriate to protect trade secrets or intellectual property versus making it public.
While a significant concern for business is present, the paramount concern is that patients and consumers are aware of how drugs are determined safe and effective, before, during and after their approval. Ultimately, this task force needs to have at the top of its mission, the idea of providing more information to the public to make informed decisions, and for doctors to give the best advice to their patients about treatment.