Two or three times a year, like clockwork, companies developing products with some component of government funding come under assault from proponents of price controls or other forms of restraint, who trot out proposals for greater federal control over the private sector.

Earlier this year, for example, Sen. David Pryor, D-Ark., introduced a bill (S. 2239) that would have imposed price controls on Medicare drugs developed with any NIH funding, whether through intramural (NIH) or extramural (university or research institute) programs. Rep. Ron Wyden, D-Ore., routinely makes similar proposals.

Fans of the pricing provisions in CRADAs will get a second chance to testify on the subject at a meeting to be held on Sept. 8, after complaints that they didn't get enough airtime for their side of the story at a meeting in July. The new hearing will hear "consumer and other public interest perspectives" on "how best to ensure that the public investment in products developed through licensing NIH technologies is adequately reflected."

Debates between protagonists and opponents of CRADA pricing clauses can sound a bit like the "am too-am not" arguments children have on playgrounds. That's because the two sides are speaking different languages: advocates of controls speak in moral terms of right and wrong; opponents speak in terms of business practicality.

Perhaps the best place to begin is with a summary of the arguments by the "controllers," based on testimony at congressional hearings by Ralph Nader and James Love of the Center for Study of Responsive Law, and Peter Arno, a professor at the Albert Einstein College of Medicine, as well as interviews with Girish Barua, a licensing specialist in the Office of Technology Transfer at NIH, and Steve Jenning, staff director of Wyden's subcommittee on regulation, business opportunities and technology. Their key points:

Government pays a substantial portion of drug development costs.

"Our guess is the government's expenditures for preclinical trials is considerably more than industry," Love says. He also estimates that the money the government spends on clinical trials is equal to 20-25 percent of the total spent in the U.S.