Full article reprinted from "The Gray Sheet" - September 7, 2009
FDA is wading through more than 900 comments on its new transparency initiative and, in an odd twist for an agency already inundated with busywork, staffers say: "keep the suggestions coming." Read more...
Full article reprinted from "The Gray Sheet" - September 7, 2009
FDA is wading through more than 900 comments on its new transparency initiative and, in an odd twist for an agency already inundated with busywork, staffers say: "keep the suggestions coming."
In early June, FDA announced the formation of a Transparency Task Force, headed by Principal Deputy Commissioner Joshua Sharfstein, which would meet this summer and fall (1 'The Gray Sheet' June 8, 2009).
The agency simultaneously set up a task force Web site, including a Transparency 2 Blog, and opened up the FDA Dockets for additional comments on how the agency can explain regulatory decisions better - and where transparency might go too far into divulging proprietary secrets.
The task force consists of Sharfstein, the directors of each of FDA's centers, acting Associate Commissioner for Regulatory Affairs Michael Chappell, acting Chief Counsel Michael Landa and acting Chief Scientist Jesse Goodman.
Attorney Afia Asamoah, special assistant to Sharfstein, is helping to staff the task force, and policy analyst Erik Mettler is overseeing the blog.
After an initial flood of comments from consumers, patients, health care professionals, regulated industry and others on the dockets, originally closed Aug. 7, FDA reopened the comment period until Nov. 6, ahead of the second task force meeting.
The blog will be active through November or so.
"The task force greatly appreciates the input and feedback it has received to date," members of the transparency task force wrote on the blog Aug. 18.
FDA will draw on this diverse input as it prepares to report findings and recommendations to FDA Commissioner Margaret Hamburg. The report will be submitted in December or January, and next steps depend on the nature of the recommendations, Sharfstein explained in an e-mail.
Device makers have highlighted a few areas where they think FDA should focus its attention first. Most require no changes in legislation, they say, only better use of established policies and procedures.
Making Good Guidance Practices Better
Industry representatives AdvaMed, the Medical Device Manufacturers Association (MDMA) and the Combination Products Coalition, among others, say FDA's guidance development process is most in need of an overhaul.
"There is room for improvement," AdvaMed's Janet Trunzo emphasizes in Aug. 6 3 comments. A better guidance development process would provide a clearer understanding of FDA's operations, activities, processes and decision-making, she says.
"Guidance is the agency's primary vehicle for communicating regulatory processes and substantive expectations to the public and industry," the Combination Products Coalition's Bradley Thompson adds in Aug. 7 4 comments. "Good guidance creates transparency."
The groups agree the time is ripe to reexamine current Good Guidance Practices, established in 2000 to improve guidance development by ensuring higher-quality guidance, fewer outdated drafts, easier online access and implementation of guidance as non-binding recommendations, not de facto rules.
Good Guidance Practices have brought "significant and laudable improvements," Thompson acknowledges, but it is time FDA refocused on certain fundamental GGP principles.
For one, FDA should allow more informal communication during guidance development, Thompson suggests.
Currently the agency remains fairly tight-lipped once a draft guidance is published and a final is pending. But there are no legal restrictions on communication while guidance is being considered, Thompson writes.
FDA should seek outside feedback as early as possible - even before issuing draft guidance, the device industry groups recommend.
Input from industry and other experts is especially beneficial when FDA "lacks depth in a particular area of expertise," AdvaMed's Trunzo writes.
Industry Wants More, And More Useful, Guidance
Meanwhile, the production of key guidance documents has slowed "dramatically" over the years, the CPC's Thompson writes, and those that are issued are not always useful.
The trade group has been awaiting draft guidance on companion drug/diagnostic development ever since FDA issued a concept paper on the topic in 2005 (5 'The Gray Sheet' April 7, 2009).
AdvaMed says FDA should tell the public when it is "seriously considering" drafting a guidance document to ensure that the final product is well-informed and useful to industry.
Since fiscal year 2008, CDRH has issued an annual list of guidance documents it is considering developing that fiscal year. Anyone can comment on the list, prioritizing among the list or offering additional suggested topics, for example.
But industry groups say the list is too long and ultimately unrealistic. "This list is often not indicative of agency action," Trunzo writes.
The FY 2009 list, for example, includes 90 guidance documents FDA was considering this year. CDRH issued a few of them, such as guidance on assay migration studies for IVDs, user fees and refunds and electronic medical device reporting, but most are so far unaddressed.
"We would ask the agency to put more thought into the planning process, so that the resulting list has more meaning," CPC writes.
On the other hand, since FDA began posting the list and accepting feedback on it, only five groups have ever offered suggestions, including AdvaMed in FY 08 and Boston Scientific in FY 09.
Finally, the groups urged FDA to respond, at least generally, to stakeholder comments in the final guidance, and to finalize drafts in a more reasonable time frame.
The agency can take years to finalize draft policies, the Biotechnology Industry Organization lamented in Aug. 5 6 comments. This "time-consuming and burdensome process" may create a disincentive for FDA to develop guidance in key areas, BIO says.
Advisory Panel Touch-Ups
Similarly, the groups say improvements to FDA's advisory panel system could increase transparency.
"One of MDMA members' greatest concerns involves the lack of transparency and predictability in the current FDA panel process," the trade association's president Mark Leahey 7 writes.
In recent years, he says, the process has become "unpredictable and opaque."
The group offered a number of proposals, ranging from reforms to improve panel composition to strategies for improving the actual meeting and voting process.
The Alliance for Specialty Medicine 8 offered more than a dozen specific suggestions on how to improve the panel process, such as enhancing the education and training of panel members, lengthening members' terms, working more closely with medical societies to find new members, and creating a non-voting medical society seat on each committee or panel.
The Alliance is a coalition of 10 national medical specialty societies, including the American Academy of Orthopaedic Surgeons, Heart Rhythm Society and the Society for Cardiovascular Angiography and Interventions.
Finding Balance Between Transparency, Innovation
FDA will have to field these and myriad other suggestions from the device industry, consumers and advocacy groups in the coming months.
In addition to the docket, blog and task force meetings, the agency met with White House staff and health care investors Aug. 11 to hear suggestions and concerns. The group included Sharfstein, U.S. Chief Technology Officer Aneesh Chopra, members of the White House Open Government Initiative and about a dozen investor reps (see sidebar " 9 Investors See An Opportunity, Not A Threat ").
The medical products industry is most concerned that FDA strike an appropriate balance between sharing more information with the public and protecting trade secrets.
The National Institutes of Health's ClinicalTrials.gov database represents one way of striking that balance, AdvaMed's Trunzo notes. Device makers must submit certain clinical trial information to the database, but NIH will not post the information until the product is cleared or approved by FDA.
Any proposals from FDA should be "carefully evaluated" to ensure that they focus on public health benefits and do not inadvertently undermine innovation, AdvaMed concludes.
- Jessica Bylander
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