FDA Is Growing Reluctant To Communicate With Companies, Industry Charges

Article preview from "The Gray Sheet" - April 19, 2010

FDA regulators have become more reluctant to cooperate with device sponsors, industry reps maintain.

FDA Is Growing Reluctant To Communicate With Companies, Industry Charges

Article preview from "The Gray Sheet" - April 19, 2010

FDA regulators have become more reluctant to cooperate with device sponsors, industry reps maintain.

For the third phase of its Transparency Initiative, FDA is collecting information on ways it can improve its openness with regulated industry (The Gray Sheet' March 15, 2010).

"The frequency of FDA's interactions with companies appears to have decreased," device trade group AdvaMed charges in April 12 2 comments.

"Scheduling meetings or conference calls to discuss device submissions is more difficult for companies than it has been in the past."

The group says this "detrimental" trend "undermines the ability of companies to understand FDA's thinking about particular regulatory issues and processes."

In a recent listening session between FDA and device industry reps, the Medical Imaging and Technology Alliance (MITA) also chided FDA for poor communication with companies (The Gray Sheet' March 22, 2010).

MITA Coaches FDA On Communicating With Firms

The key to increasing transparency "is establishing and maintaining open channels of communication on an ongoing basis," MITA maintains in April 2 4 comments.

To accomplish this, MITA recommends that FDA respond quickly to industry input on important regulatory issues, keep firms apprised of its plans to revise existing guidance or develop new guidance, provide as much advance notice as possible of upcoming public meetings, and post timely, clear messages on the Web.

FDA could also communicate through workshops, Federal Register notice requests for comments, and private meetings with industry or individual companies, when appropriate.

"In instances where particular issues affect a specific industry, MITA believes it is important for FDA to hold private meetings" to avoid "wasting time and resources with back and forth communications," the group writes.

One way to ensure that FDA is providing useful and timely answers to industry questions is to establish a "quarterly transparency survey," MITA suggested.

The survey could track the number of product submissions, the amount of time an application remains in the FDA reviewer's portfolio, the time between submission and FDA's issuance of an "additional information" letter, as well as the number of product approvals and rejections, and the number of appeals of FDA decisions, MITA writes.

FDA's Advisory Panel Practices Sub-Par - AdvaMed

AdvaMed supports these methods of interface and contends that FDA has been slipping in this regard.

For "several recent advisory panels," for example, FDA failed to communicate in advance the focus and content of the meeting, forcing public attendees to comment "on the spot" on FDA's concerns, AdvaMed writes.

In other instances, the agency provided panel materials "so late that it is difficult for panel members to properly prepare," the group notes.

AdvaMed says FDA can "easily" rectify the situation by distributing panel meeting documents well in advance of the meetings either in the Federal Register or on its advisory panel Web site "so all stakeholders may adequately prepare and participate."

Industry-Supported Education, Training

FDA should also participate more often in regulatory training and education activities sponsored by industry, AdvaMed suggests.

The group points to its Medical Technology Learning Institute (MTLI), a regulatory and technical training program.

MTLI and FDA have sponsored several courses together, but, AdvaMed says, "it is our understanding that some FDA staff have recently been reluctant to participate in MTLI courses, perhaps under the mistaken impression that participation in these educational efforts ... is not

supported by the current FDA administration."

Because FDA alone lacks the resources to train and educate the entire regulated industry, it should leverage resources like MTLI, AdvaMed argues.

Guidance Development Tips

As in the past, guidance development was singled out as an important means for FDA to communicate its thinking to sponsors.

Industry has been lobbying FDA to improve and speed up its guidance development process for years; improving guidance development is one of the FDA device center's 2010 strategic priorities.

AdvaMed offers specific steps to further enhance the guidance development process, including establishing a periodic review and update of special controls guidance documents (see sidebar: " 5 Guide To Better Guidance? ").

Recall Classification Criteria

Finally, AdvaMed calls for more clarity on FDA's criteria for classifying device recalls.

More recalls than ever are being categorized as Class I, the most serious type, including some that in AdvaMed's estimation would have earned only a Class II designation in the past, the association says.

AdvaMed urges FDA to share its criteria for recall classification with industry, and perhaps to accept industry input and expertise on the topic.

- Jessica Bylander

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