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The Friday Update — September 11, 2009

November 27, 2009


Metrics Project Update — Comments Requested. Thank you to those who have submitted comments. We are still accepting written comments from the subgroup members and encourage members to submit as soon as possible.

Special Thanks to Margaret Anderson, Alliance Board Member and FasterCures’ Chief Operating Officer, for emphasizing the importance of a better funded FDA in a recent edition of the FasterCures Blog. Margaret’s column can be viewed at: Improving the Science of Drug Safety


President, Congress and traffic have all returned to DC after Labor Day. For some reason, this makes me happy … maybe because I can associate each with the word “jam.”

The President came to Capitol Hill on Wednesday night to create renewed momentum for health care reform. His poll numbers have declined, while popular concern about health reform has increased. His jam is that he doesn’t have enough votes to pass legislation, primarily because of divisions within the Democratic party. The speech may move his poll numbers, but it may be weeks before we know whether he has broken the Congressional logjam on health reform. While FDA is not directly affected, a number of provisions affecting FDA are contained in the House E&C and Senate HELP reform bills. The most far-reaching would create a new regulatory pathway for follow-on biologics.

Congress is in a different kind of jam. Health reform will happen (or not), but there is no denying that other work is not getting done while reform plays out. Fortunately (for us), the FY 10 Agriculture appropriations bill has already passed House and Senate. A conference agreement can be expected soon and FDA’s appropriation will be in place before the new fiscal year starts on October 1.

The death of Senator Kennedy has been sad. It is a loss for Congress and the American people. His passing created something of a jam over who would chair the Senate HELP Committee. This resolved on Wednesday when Senator Dodd chose to remain chairman of the Banking Committee and Senator Harkin decided to leave the chair of Agriculture to become chairman of HELP.

Missing from a lot of the news stories is that Harkin will run the HELP Committee, while also chairing the appropriations subcommittee responsible for funding most DHHS programs. This is an extraordinarily powerful positioning. Harkin is also the #2 Democrat on the agriculture appropriations subcommittee, which oversees FDA. Pure speculation on my part: if Senator Specter is re-elected as a Democrat and is granted seniority, there may yet be a jam on appropriations. Perhaps Harkin takes over agriculture appropriations (sure to make Iowa happy), Specter takes Labor-HHS from Harkin, and Senator Kohl gets a bigger subcommittee to chair. Under this scenario, Senator Harkin might yet become the Senate appropriations chairman who matters to FDA.

In contrast, it is safe to assume that the House is stable. Representative Waxman will chair House E&C and Representative DeLauro will chair agriculture appropriations for the foreseeable future. No jam there.

And then there are the DC traffic jams. I am sure I don’t need to explain them.

Fortunately, all of the member of Congress named in this column are supportive of FDA. So, however the jams work themselves out, there is opportunity for our cause to prosper.

Have a great weekend and expect lots more to happen next week.

Note: This analysis and commentary is written by Steven Grossman, the Deputy Executive Director of the Alliance.


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