AAOS shares concerns on device approval, guideline development processes

In response to two presidential memoranda calling for greater transparency within federal agencies, the U.S. Food and Drug Administration (FDA) recently held a public meeting to discuss steps to provide information to the public in a faster, user-friendly process.

The AAOS was represented at the meeting by staff from the office of government relations. Also in attendance were representatives from the science community, the pharmaceutical and device industry, consumers groups, and other stakeholders.

The FDA’s transparency task force—led by Joshua M. Sharfstein, MD, principal deputy commissioner—will develop recommendations on FDA activities and decision-making processes, which will be presented to Commissioner Margaret A. Hamburg, MD.

“Dr. Hamburg sees transparency as very important to the credibility of the FDA. When people understand why, how, and on what basis the FDA makes decisions—decisions that are very important for the health of Americans—they will be able to trust the agency more,” said Dr. Sharfstein.

Looking for suggestions
As part of the president’s order to review all policies created prior to his administration, the FDA will be changing its current operations— such as internal policies and procedures, standards, information formats, and guidance—to improve the agency’s ability to provide such information to the public in a timely and effective manner.

During the meeting, the FDA sought public input on issues related to transparency, particularly for ways that the agency can better explain its operations, activities, processes, and decision-making. In addition to finding better vehicles for informing the public, the FDA hopes to identify what specific information should be provided, including information on enforcement actions, recalls, and product approvals.

Both internal and external barriers exist that may complicate the agency’s goal of providing useful and understandable information. Internal barriers may include the need to protect confidentiality, while external barriers include the public’s level of health literacy and the needs of special populations. The taskforce asked participants to help identify appropriate tools and new technologies that can be applied in its public information efforts.

The task force is expected to complete its work in 6 months and submit a written report on its findings and recommendations to the commissioner. The AAOS, along with other members of the Alliance of Specialty Members, will also submit written recommendations.

AAOS shares concerns
AAOS staff also met with Commissioner Hamburg, Principal Deputy Commissioner Sharfstein, and other FDA in a small-group meeting in late June. Along with the other medical specialty societies, the AAOS has specific concerns, which it expressed to the FDA officials.

One of these concerns is the premarket notification or 510(k) pathway for medical devices, which has been the subject of much recent debate. Commissioner Hamburg stated that she will call for an objective review of the program and assess the application of some of the “substantial equivalence” determinations.

Another is that the lengthy processes for developing guidance documents. The AAOS suggested that the FDA allocate more resources for those endeavors.

The AAOS also shared its concerns on the following issues:

• the unique device identification initiative (UDI) that would provide bar coding or radiofrequency to identify devices
• post-market surveillance efforts
• pediatric device development
• selection of participants for FDA panels
• the sentinel event initiative
• antibiotic development
• approval process issues
• risk, evaluation, and mitigation strategies (REMS)

Commissioner Hamburg and Deputy Commissioner Sharfstein acknowledged that they needed and valued outside expertise to assure the public’s health and pledged to partner with medical societies in numerous ways.

Jeanie Kennedy is manager, regulatory and government affairs, and Nicholas Piatek is communications specialist in the AAOS office of government relations.

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