Congress Poised to Block Drug Reimportation Once Again

On Friday, October 28, 2005, the House is scheduled to vote on the Conference Report for H.R. 2744, the USDA and Food and Drug Administration (FDA), and Related Agencies spending bill for fiscal year 2006. The compromise bill drops language that had been included in the House version of the bill that would have prevented the FDA from blocking the reimportation of FDA approved prescription drugs from specified foreign countries. This is the second successive year that this proposed action has been passed by the House, but rejected by the Senate, and dropped from the FDA spending bill.

AAHF has supported giving Americans access to cheaper drugs and supported reigning in the authority of the FDA to control health care choice access. Despite this setback, included in the compromise bill are new tougher conflict of interest and public disclosure requirements for members serving on FDA advisory committees and panels as regards to relationships with pharmaceutical companies.

AAHF and other health freedom groups have long advocated for more transparency to end the undue influence of big pharma on FDA decision making. AAHF is pleased that some members of Congress have stepped up and forcefully addressed this long overdue issue. The compromise Conference Report is expected to pass the House, and the Senate, and be approved by the White House.

Durbin Amendment - Adverse Event Reporting

When it comes to federal agencies, there are two types of bills that Congress considers. There are authorization bills that set policy goals and direct where monies are supposed to be spent, and appropriations bills that actually distribute the money. In the absence of the passage of an authorization bill, the agency appropriation legislation is used to serve these dual legislative responsibilities.

The House and the Senate have both passed the spending bill for fiscal year 2006 for the Department of Defense (DOD), HR 2863. The House has passed its Department of Defense authorization bill, HR 1815. The Senate has yet to pass its DOD authorization bill, S 1043.

It is to this last bill, S 1043, that Senator Durbin has proposed his Amendment #1379. The Durbin amendment would require manufacturers who sell dietary supplements on military bases, except for vitamins, to submit reports of adverse health reactions to the Food and Drug Administration (FDA).

However, Amendment 1379 would also apply to nonmilitary sales of supplements to consumers.A hundred or so amendments have been filed for S 1043, including the Durbin amendment. Senate leaders from both parties, including Senator Durbin, the Assistant Minority Leader, are now in negotiations over what amendments will be considered and voted on individually, and what amendments could be considered “en bloc” and adopted by unanimous consent, without a full Senate vote.

We're keeping an eye on this amendment and will keep you informed.

FDA Consumer Research Report on Dietary Supplement Claims

The FDA has released a 41-page report on Effects of Strength of Science Disclaimers on the Communication Impacts of Health Claims. The report discusses consumer research FDA conducted to evaluate whether the agency's current approach, under its interim guidance, to communicate to consumers the strength of science underlying a qualified health claim is effective. FDA intends to use this research and other relevant consumer studies to evaluate its approach to qualified health claims on conventional foods and dietary supplements.

For dietary supplement manufacturers and suppliers, the issue of health claims has existed since Pearson vs. Shalala – the landmark case in which AAHF, with four other plaintiffs, sued the U.S. Food and Drug Administration and won. We sued the agency for violating the First Amendment as well as the Administrative Procedure Act by not allowing the dissemination of truthful, scientific information on dietary supplement labels, and by holding manufacturers to an undefined standard called "significant scientific agreement. We also raised this issue when we testified before Congress last year at a House Government Reform hearing entitled Ten Years After the Implementation of DSHEA: The Status of Dietary Supplements in the United States.

The FDA intends to use the findings from this research and other relevant consumer studies to evaluate its approach to qualified health claims for dietary supplements. Both unqualified and qualified health claims may be used now. To date, there are only 12 qualified health claims that can be used for conventional foods and dietary supplement labeling. For qualified health claims, the FDA issues letters of enforcement discretion when there is credible scientific evidence, in their view, to support a claim.

With an initial review of the report, we found the following of most interest.There was evidence that respondents' perceptions of product health benefits were not diminished by conveying greater scientific uncertainty for a claim. In some cases conveying more scientific certainty for a claim actually led to more negative perceptions of product health benefits. This overall pattern of results suggests important caveats on the possible effectiveness of strength of science disclaimers.

The FDA intends to hold a public meeting to discuss the study on Thursday, November 17th from 9:00 am to 4:30 pm at FDA's Wiley Building, 5100 Paint Branch Parkway, College Park, Maryland. The meeting will provide an opportunity for attendees to provide comment to FDA on the new research findings. Please visit the FDA website for more information and to download the report.

Don't forget to visit AAHF's online Action Center to contact your representatives on important health freedom bills.