Good News/Bad News/Good News -- Sort of

  • by: |
  • 10/31/2005

First the good news — congressional conferees approved the FY 06 Agriculture Appropriations conference report that includes $1.5 billion for FDA, $40 million above the current fiscal year. Now the bad news — that’s $10 million less than the President requested. Now the good news — missing from the conference report is House language regarding importation of prescription drugs. Now the bad news — retained in the conference report was (compromise Senate)language on conflict of interest waivers for FDA advisory committees. That amendment says none of the agency’s funds may be used to grant a waiver of a financial conflict of interest requirement for any voting member of an advisory committee or panel or to make a certification for any voting member. Now the good news (sort of) — the ban does not apply if (1) not later than 15 days before an advisory committee or panel meeting the HHS Secretary discloses on FDA’s Web site the nature of the conflict of interest at issue and the nature and basis of the waiver or certification, or (2) in the case of a conflict of interest that becomes known to the HHS Secretary less than 15 days before a meeting, the Secretary discloses it as soon as possible, but in no event later than the day of the meeting. In addition, none of the agency’s funds may be used to make a new appointment to an FDA advisory committee or panel unless the FDA Commissioner submits a quarterly report to the HHS Inspector General and the House and Senate Appropriations Committees on efforts made to identify qualified persons for such appointments with minimal or no potential conflicts of interest. That’s a whole lot more paperwork for an already overworked and understaffed agency that didn’t even get the full appropriation requested by the President. You want FDA reform? Show me the money.

CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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