FDA may publicly disclose more information on specific devices prior to marketing approval under a May 19 proposal to increase transparency.
Article preview from "The Gray Sheet"- May 24, 2010
FDA may publicly disclose more information on specific devices prior to marketing approval under a May 19 proposal to increase transparency.
In total, FDA is proposing 21 policy changes to increase the availability of information it has on regulated products to help the public better understand agency decisions.
Public comments on the draft proposals, which are outlined in a May 19 FDA 1 report, are due July 20.
Once comments are received, FDA's transparency task force will recommend certain proposals to Commissioner Margaret Hamburg. Not all of the proposals will be implemented, the report notes, so FDA is also seeking comment on which should be top priorities.
Nevertheless, the report reflects new FDA thinking on what information about medical products should be considered confidential and protected.
"The task force believes implementing some of the proposals would accelerate the development process for medical products by allowing companies to learn from the successes and failures of other products," FDA Principal Deputy Commissioner Joshua Sharfstein and transparency initiative chief Afia Asamoah write in an editorial published online in the New England Journal of Medicine May 19.
Opening The Door To Pre-Market Data Disclosure
Among the proposed changes, FDA is considering disclosing the existence of investigational device, drug and biologic applications, and announcing sponsors' withdrawal or abandonment of investigational product applications whenever those occur.
FDA may also announce when a pre-market application, such as a device PMA or 510(k), is submitted, listing information such as the application sponsor, proposed indication and trade name, as well as the date the application was received.
The agency would similarly disclose subsequent withdrawal or abandonment of pre-market applications, and describe any significant safety concerns with withdrawn product candidates.
Transparency Could Be Boon To Investors, Rivals
While "information in a withdrawn or abandoned application may still have competitive value to the sponsor," the information would help other companies and the investor community and should be shared, the task force reasoned.
Highlighting specific safety concerns "should allow researchers studying the same molecule or device, or a closely related molecule or device, to use that information to protect patients from the identified and potential risks," the report adds.
FDA is also proposing to publish online agency-issued "not approvable" letters and correspondence seeking additional information from product sponsors, along with the agency's rationale for not approving or clearing a product.
"The letter itself may be valuable to patients and health care providers who want to know whether, and when, new medical treatments will become available," the FDA report states.
Investors also could use the information to better allocate research dollars, the document suggests.
FDA notes that the European Medicines Association already makes this type of marketing and regulatory decision information available online; thus, many firms are already familiar with the process.
The agency is further considering publishing summaries of relevant safety and effectiveness information from pending pre-market applications, when disclosure is in the best interests of public health.
"Blanket protection" of all pre-market information "has not been shown by industry to be economically necessary," the report states.
However, FDA will hold off on releasing raw data from pending product applications. The report proposes convening a group of internal and external stakeholders to discuss possible uses of such information, and how it should be disclosed.
Device trade group AdvaMed says it applauds the agency's new focus on transparency, but is concerned about the proposals to disclose more pre-market information.
"Care must be taken to protect companies' proprietary information," the group emphasized in a May 19 statement.
AdvaMed plans to submit more detailed comments to FDA in the near future.
Adverse Event, Enforcement Data Transparency
FDA also proposes to expand public access to adverse event report information, and present it in a format that is easily searchable.
But, because adverse events are generally underreported, FDA will add a clear disclaimer about the limits of the information.
On the enforcement front, the agency is considering announcing in its weekly FDA Enforcement Report each time the U.S. Department of Justice files a case on FDA's behalf, as well as the final determination of the case, if known.
FDA may also release agency work plans, including the Office of Regulatory Affairs' field work plan, though only after a period of five years.
Disclosing FDA's planned enforcement priorities earlier than that may allow companies "to more easily avoid detection and circumvent the law," the task force cautions.
Finally, among the proposals, FDA is deciding whether to disclose the names of every company it inspects, the date of the inspection, the type of products involved and the final classification of the inspection, indicating whether violations were found.
These disclosures "may serve as an incentive to firms to correct violations," the report suggests.
Legal Implications Yet To Be Examined
Principal deputy commissioner Sharfstein said FDA has not yet thoroughly considered the legal or resource questions associated with each proposal.
"The first question is 'what's the right thing to do?'" he told reporters May 19. "The next stage would be ... to really do the legal analysis as well as the resource analysis."
"Some of these are going to require some legal changes," he acknowledged.
The public transparency report is part of a broader agency effort launched last summer to increase FDA's transparency to industry and the public.
The task force reviewed more than 1,500 public comments from two public meetings, an online blog and an FDA docket to craft the 21 proposals.
Separate draft proposals on FDA transparency to regulated industry, rather than to the public, are expected out this summer.
- Jessica Bylander
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