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not designed to address innovations in the review process,

but to address the feasibility of outsourcing the FDA's

workload, and that it could find no accreditation criteria

suitable for 510(k) review.

Congressional Calls for Reform

Members of Congress from all points of the ideological

spectrum and from both parties have called for reform.

More basic change must occur in the very way FDA

sees its mission.  FDA . . . must come to under-

stand and believe that . . . consumer protection

means not only protecting consumers from unsafe

and [in]effective products, but also assuring that

individuals have timely access to . . . improve-

ments and breakthroughs in biomedical therapies

and food technology.  [Then-Sen. Nancy Landon

Kassebaum (R-Kan.)]53

[On] the issue of delays. . . . One of the things

that emerge from conversations with people in the

biotechnology community is that they are deeply

concerned that science has now surpassed the regu-

latory framework of the agency. . . . [T]he regu-

latory framework . . . [is] from a whole other era

and that now science is moving at such a rapid

rate that the old mechanisms aren't working. . . .

[W]e need a passion for change.  If not, I believe

that Congress is going to roll right over [FDA].

[Sen. Barbara Mikulski (D-Md.)]54

Even FDA Commissioner Kessler said he saw the need for

change, or at least saw the congressional sledgehammer hang-

ing over the FDA.  "[W]e are working hard to make the FDA

more efficient," and "[W]hen it comes to getting needed

therapies to dying patients, the riskiest thing we can do is

be unwilling to take risk."55  Discussing "accelerated ap-

proval" of products for life-threatening conditions, Dr.

Kessler said, "I think we have an obligation to speed them

up."  On the same day, he responded to criticism that the

FDA is slow, pugnacious, and obstructionist by saying, "We

need to fix it."56

All of the above quotes are from a single hearing

before the Senate Committee on Labor and Human Resources in

the 104th Congress in 1995.  Despite the apparent urgency,

no legislation about the FDA emerged from that Congress.

Actions in the 105th Congress