Endocrine Insider
September 27, 2007

Last week, the U.S. House of Representatives and Senate both passed the FDA Amendments Act of 2007 (H.R. 3580), which contains language expanding requirements for reporting clinical trials and their results in clinical trials registry databases. The bill reauthorizes the U.S. Food and Drug Administration (FDA), the current authority of which expires at the end of this month. The President is expected to sign the bill into law by September 30.

Earlier this year, the House and Senate had passed independent bills reauthorizing the FDA, each of which expanded requirements for reporting to clinical trials registries. The bills differed somewhat in the stringency of the reporting requirements and the mechanisms by which reporting would take place. Congress was under time pressure to pass compromise legislation quickly, and so they bypassed the typical conference process of reconciling the two bills and instead negotiated an altogether new House bill (H.R. 3580). Though the process was atypical, the outcome was not. The new bill contains clinical trials registry language that is a compromise between the two original bills.

Some of the new requirements include expansion of the types of trials that must be registered to include clinical trials (other than preliminary studies) of all drugs, devices, and biologics; reporting of results on efficacy for registered trials; and reporting of additional results for approved and unapproved drugs and devices. Implementation of the new requirements is at the discretion of the Secretary of Health and Human Services and is not clearly outlined at this time.

The Endocrine Society recognizes that the new mandate presents at very least potential confusion for its clinical researchers and at worst potentially burdensome reporting requirements. The Society will work both independently and with other concerned organizations to mitigate any burden to the extent possible and to inform members of specific new requirements arising from the legislation.

The full text of the legislation can be read here: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?
dbname=110_cong_bills&docid=f:h3580eh.txt.pdf.