Clinical trial registry requirements contained in the recently enacted FDA Amendments Act are likely to be clarified in a "technical corrections" bill in the coming weeks, device industry lobbyists say.

The Act, signed by President Bush Sept. 27, renews FDA user fee programs for device and drug companies while reforming an array of other programs impacting medical product manufacturers.

One significant and complex provision of the Act greatly expands the requirements for submitting information to the National Institutes of Health's ¹ ClinicalTrials.gov database. Within the next few months, device and drug manufacturers will need to begin submitting basic information and clinical results for all FDA pivotal-phase trials to NIH for public posting. Firms will be subject to fines for noncompliance.

Previously, only pharmaceutical companies were required to post, and they only needed to include information on a small subset of drug trials.

Delays in working out the differences between the House and Senate on the clinical trial registry section of the FDA bill was one of the main reasons why a final bill was not sent to the president until just days before the user fee programs expired (² Also see "Congress Approves FDA Reform/User Fee Bill In The Nick Of Time" - Medtech Insight, 24 September, 2007., p. 3). The resulting provisions have left device companies struggling with the details.

AdvaMed President Steve Ubl says members of Congress are considering some of the complexities as they comb through the act for needed corrections.

"There is discussion on posting and how that will actually work. And there is discussion on [having] adverse event reports in the database in the context of the technical corrections," he said Oct. 2 at the AdvaMed 2007 conference in Washington, D.C.

Ubl also suggested that industry reps are engaging Congress in the context of the corrections bill on two additional issues where they have lingering concerns - pediatric provisions that give FDA the authority to mandate postmarket surveillance for products that could have "significant use" in pediatric populations, and a provision requiring FDA to reduce the number of conflict-of-interest waivers granted to advisory committee members by 25% in the next five years.

"There may well be technical corrections needed in those areas," Ubl said.

House and Senate staffers could not confirm what specific language might be altered in a technical corrections bill. "The entire bill will be scoured for technical and other needed changes, which is a normal process for a bill of this length and complexity," a House Energy and Commerce Committee aide said.

A Senate staffer said work on the technical corrections bill will take place between "now and the end of the session."

Registry To Include Trial Descriptions And Results

The FDA Amendments Act requires device makers to send NIH a brief summary of each 510(k), PMA or Humanitarian Device Exemption pivotal trial, the primary purpose of the trial, the study design, the patient eligibility criteria and a host of additional basic descriptors soon after a study begins.

In a lobbying victory for the device industry, none of that information will be posted on the Internet by NIH until after the product is cleared or approved for marketing, in order to avoid premature release of trade secrets (³ Also see "Industry Alarmed By Third-Party Audit, Registry Provisions In Draft House Bills" - Medtech Insight, 11 June, 2007., p. 4). Drug trials data, on the other hand, will be posted prior to product approval.

Device and drug manufacturers will also be required to submit basic results from the trials, including primary and secondary endpoint outcomes, and identify a person who can provide the public with more scientific information about the data.

Within 18 months, HHS is required to issue regulations for including "serious" and "frequent" adverse events from trials in the database. One element that will definitely be included in the corrections bill is language clarifying that device trials, as well as drug studies, are subject to the adverse event requirements. The word "devices" was inadvertently left out of this section.

But Ubl says more question remain on how and when adverse events will need to be reported to the registry.

- David Filmore (d.filmore@elsevier.com)

FDA Technical Corrections Bill Could Address Trial Registry Requirements

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