Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

House AER bill

This article was originally published in The Tan Sheet

Executive Summary

Rep. Chris Cannon (R-Utah) introduces a House version of legislation mandating adverse event reporting for dietary supplements and OTC drugs Sept. 25. The bill goes to the House Committee on Energy & Commerce, where a hearing is expected shortly after the House reconvenes in November. The "Dietary Supplement & Nonprescription Drug Consumer Protection Act" (HR 6168) requires manufacturers, packers or distributors of OTC drugs or dietary supplements "whose name appears on the label" to report any serious adverse events to FDA, the legislation states. The provisions of the bill would take effect one year after enactment. Sen. Orrin Hatch (R-Utah) believes the introduction of the House supplement AER bill "will boost [the legislation's] prospects for enactment this Congress," according to a staffer. It is likely the Senate will vote on the related legislation (S 3546) in early October, according to several supplement industry trade groups (1"The Tan Sheet," Sept. 18, 2006, p. 6)...

You may also be interested in...



Adverse Event Bill Down To The Wire As Congress Wraps Up

Congress was poised late last week to pass a bill requiring mandatory adverse event reporting for dietary supplements and nonprescription drugs

Senate Vote On Adverse Event Reporting Bill Expected By October

The Senate likely will vote on the "Dietary Supplement & Nonprescription Drug Consumer Protection Act" (S 3546) before they adjourn in early October, according to several supplement industry trade groups

Clinical Trial Diversity Would Benefit From Regulatory, Financial Incentives, Experts Say

Access to expedited regulatory pathways, marketing exclusivity and tax credits in exchange for enrolling and retaining diverse clinical trial populations could provide a ‘carrot’ to the ‘stick’ in US FDA guidance and legislative proposals; attorneys Sarah Thompson Schick and Winston Kirton also call for a re-examination of concerns about remuneration for trial participants.

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS099801

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel