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Addressing the Needs of the Wrong Customers In the earliest stages of the needs-requirements life cycle, that is, grappling with trying to identify and formulate needs, we should nd ourselves struggling to clarify whose needs should be addressed. If we do not raise that question, there is a good chance that we will address the needs of the wrong customers. Two possible pitfalls stand out here: there are multiple customers, and we address the needs of the wrong set of customers; and our personal values so color our interpretation of customer needs that we wind up addressing our own needs rather than theirs.

Virtually all the skeptics assumed that the pressure came from the pharmaceutical or biotech industries, although some people also wondered about possible Bush family influence In one of our interviews, Ira Loss, the financial analyst, described the CBERCDER transfer as a political maneuver caused by Erbitux and pressure from Congress At a House subcommittee hearing on October 10, 2002, then-Congressman Peter Deutsch of Florida outright said to Lester Crawford, It s widely alleged that the decision to transfer the review of most biological drugs from the Center for Biologics to the Center for Drugs was not originated from either center, but rather was imposed by the department at the behest of the biotech drug industry Later, in an e-mail interview, Deutsch declared, Given the testimony we d heard, it seemed like Erbitux was the catalyst Crawford s role stirs more spice into the mix.

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To print a document, select the Print command from the File menu. A standard Mac OS Print dialog box appears, with a number of advanced BBEdit printing options. Each printer type presents its own dialog box, of course; Figure B-10 shows the printer dialog box for Adobe s Acrobat PDFWriter.

He was in charge of the FDA during the time when Erbitux was reconsidered and the decision to transfer therapeutic proteins was made, and he has said the transfer decision was his alone But he was also a bit player on the political scene In late 2001 the scuttlebutt was that he would be named FDA commissioner, thus apparently beating out Richard Pazdur His would-be boss, Health and Human Services Secretary Tommy Thompson, publicly backed him for the job However, Crawford, like Pazdur, failed to get the nod The main theories circulating in Washington and Rockville are that administration brass were annoyed with Thompson for being too hasty in pushing Crawford before getting formal White House approval, or that the White House wanted an MD while Crawford is only a veterinarian In addition,.

are made purely on the scientific data. In fact, the FDA is staffed by a corps of dedicated, careful scientists. But it is, and always has been, buffeted by the conflicting demands of scientific accuracy and public pressure, of industry and consumers, and by the contradictions between two types of public need. That is why the agency is so often in the headlines; the scientific issues it confronts are also issues of important public policy. It has at times given in to some of the less-than-pure forces not often, but more than officials would care to admit. For instance, at various periods the review staff has moved faster in approving drugs, then slower, then faster, partly because of practical factors like its budget, partly because of the quality and quantity of the applications it receives, and partly because of the political pressure for speed. It is not necessarily a bad thing for a government agency to be responsive to the views of society or the pain of consumers, like the parents at the Holiday Inn, of course. But for good or ill, all these pressures have grown more powerful in recent years.

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