Serious or frequent adverse events that occur during certain medical device clinical trials will need to be posted on a government Web site under a bill passed July 30 by the House.

The legislation - the Animal Drugs User Fee Amendments Act (H.R. 6432) - passed by unanimous consent and included several "technical corrections" to the FDA Amendments Act.

FDAAA, signed into law in September 2007, renewed FDA user fee programs for device and drug companies while reforming an array of other programs impacting medical product manufacturers ("¹ Also see "Congress Approves FDA Reform/User Fee Bill In The Nick Of Time" - Medtech Insight, 24 September, 2007., p 3).

Included in the sweeping 2007 measure is a requirement that drug and device companies register their clinical trials with the National Institutes of Health to be posted on the agency's ClinicalTrials.gov site. Also, FDA and NIH are required to implement policies for manufacturers to report results from the clinical trials to the public database.

Devices Left Out 'Inadvertently,' Rep. Pallone Says

But during final negotiations on the bill, House staff "inadvertently" left out a provision stating that adverse effects information was intended to be included in the results database for both drugs and devices, said Rep. Frank Pallone, D-N.J., chairman of the House Energy and Commerce Health Subcommittee. Currently, FDAAA only mentions drugs in the registry requirements section on adverse events.

"That was a mistake," Pallone said.

H.R. 6432 adds the words "devices" to a section requiring the Department of Health and Human Services within 18 months of enactment of the legislation to issue regulations on the best methods for including information on serious or frequent adverse events in the database that is "useful and not misleading to patients, physicians and scientists."

Janet Trunzo, who heads up AdvaMed's technology and regulatory affairs office, says the device industry supports the inclusion of device adverse events as part of the clinical trial registry.

"However, the original FDAAA provision was designed for pharmaceuticals, and the technical corrections bill should include language that is more appropriate for medical device reporting," she said.

Trunzo said AdvaMed will work with FDA in developing the adverse event regulations so that they require "accurate and appropriate information."

According to FDAAA, if the agency fails to produce a clinical trial adverse event reporting regulation by September 2009, NIH is required to begin including tables in ClinicalTrials.gov registry entries listing "serious" adverse events or any events that exceed a frequency of 5% within any arm of the clinical trial, grouped by organ system.

In general, FDAAA's registry requirements are applicable to pivotal trials conducted to gain FDA approval or clearance; trials involving approved or cleared products; and pediatric post-market surveillance studies.

Under the law, device trial information will not be made public on the Web site until after the product is approved or cleared ("² Also see "FDA Technical Corrections Bill Could Address Trial Registry Requirements" - Medtech Insight, 8 October, 2007., p. 7).

Senate Expected To Follow Suit

The Senate is expected to pass similar FDAAA technical corrections as part of its animal drug user fee reauthorization package.

In addition to the trial registry provision, the House bill also includes a correction to a FDAAA provision relating to pharmaceutical citizen petitions.

Republicans on the Senate Health, Education, Labor and Pensions Committee say they are interested in making further unspecified technical corrections to FDAAA, but will not do so in this bill to avoid delays in reauthorizing the animal drugs user fee program.

- Sue Darcey (s.darcey@elsevier.com)

House Adds Device Adverse Events To Trial Registry Requirements

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