Biomedical Engineering Reference
In-Depth Information
diseases. This comprehensive review constituted one of the finest
moments in the history of RAC.
6
In 1996 and 1997, this oversight system was substantially weakened
by policy makers at the NIH and the FDA. Between 1994 and early 1996,
opposition to RAC's role in reviewing human gene transfer research
began to be expressed by some members of the biotechnology and phar-
maceutical industries, AIDS activists, and academic researchers. The
opposition ostensibly was based on the notion that RAC, meeting only
quarterly, could not respond in a timely manner to new developments in
a fast-moving arena of research. Suddenly, draft legislation appeared
that, in the course of reforming the FDA's regulatory practices, would
have abolished RAC oversight of the field. This provision was never
adopted, but a warning about RAC's unpopularity in some quarters had
clearly been sent by an antiregulatory Congress. For its part, Congress
was responding to advocates for the biotechnology and pharmaceutical
industries.
The grounds for this opposition to RAC's role were based in part on
the ambiguities cited above. In other respects, however, the amount of
hostility engendered by RAC during this time remains puzzling even now.
One can only speculate about the motives of the opponents. They surely
wanted to avoid unnecessary duplication and delay in the oversight
system for this important field. Other critics may have concluded that
RAC's quasi-regulatory review function should be located at a regula-
tory agency, the FDA. And one factor in the opposition of at least some
private companies may have been the desire for the more confidential,
and therefore less transparent, mode of regulation that occurs in the
interactions between companies and FDA regulators.
Whatever the background for his decision, NIH director Harold
Varmus announced his plans for the future of RAC in a May 1996 speech
given at Hilton Head, South Carolina. No text of the speech is available,
but on the basis of reports on the speech and an interview with Varmus,
Eliot Marshall of
Science
published an article on the director's plans to
“scrap the RAC.”
7
Varmus's speech was followed in June 1996 by attempts by NIH
officials to explain the rationale for his new plan to members of
Congress and their staff members. In July 1996, the
Federal Register
published the formal NIH proposal to abolish RAC and turn over vir-
