Monday, March 16, 1998
The word in Washington is that the Clinton administration is
close to making a formal announcement of its nomination of Jane Henney to be
the new FDA commissioner. If true, the next step would be confirmation hearings
in the Senate, which will be Congress's opportunity - and thus its constituents'
opportunity - to lay out the themes it believes are important for the new head
This is thus a good time to think through those issues that
are important to the biotech industry and to make sure they are communicated
to Congress, the administration and the nominee.
Making the industry's feelings known is particularly important
for three reasons: First, success in implementing the FDA Modernization Act
of 1997 depends on putting those reforms into practice. While the agency's professional
staff has been extraordinarily forthcoming in its willingness to work to implement
reform, the head of FDA sets the tone for the agency. It is therefore extremely
important to have a commissioner in place who understands and supports those
reforms and creates an environment at FDA that is conducive to a productive
working relationship with industry.
Second, the Clinton administration's fixation on tobacco threatens
to divert attention and resources from FDA's role in reviewing new drugs. The
tobacco initiative, together with the White House's pressure on companies to
run pediatric trials of new products, raises the specter that politically correct
decision making could come to color the agency's attention and budget. This
would be a profound setback to science-based regulation.
Finally, the trend in Europe towards increasing regulation
of genetically modified products requires a firm commitment by the U.S. that
it will continue to insist on science-based regulation. This, in turn, makes
it important to set a consistent example by appointing a strong supporter of
science-based decision-making to the top of FDA.
Lessons from Europe
A comparison of how regulatory decisions have been made in the U.S. and Europe illustrates what's at stake.
In the U.S., the government has tackled public uneasiness over new technologies by producing scientific analyses showing that there is no legitimate cause for concern, or that products produced using "conventional" methods can't be distinguished from those produced using "genetic engineering."
U.S. regulations thus have been based on the premise that it is the final product that counts, not the process by which it has been produced (see the U.S. model, A4).
In contrast, European governments have frequently chosen to address those same concerns through regulations that separate out old from new products, giving consumers a choice between the two rather than showing that there is no scientific justification for the distinction.
The rationale, used by European regulators as well as by environmental and anti-biotech consumer groups on both sides as the Atlantic, is the so-called "precautionary principle," which is based on the notion that the possibility that the new products could cause some harm cannot be absolutely ruled out.