Genetic Engineers Flex Their Muscles in Washington

Biotech flexes its muscles
Companies start to make their presences felt in Washington
By Anthony Shadid, Boston Globe Staff, 6/15/2001

The bio technology industry, long overshadowed on Capitol Hill by its
richer and more influential cousins in the pharmaceutical sector, is
beginning to flex its financial muscles.

Over the past few years, biotech companies and trade groups have doubled
and even tripled their spending on campaign contributions and lobbying for
a legislative agenda that is increasingly their own.

Amgen, the largest US biotech company, has earned a spot as one of the top
10 drug companies in spending on lobbying. And its contributions to
candidates and political parties more than doubled from 1996 to 2000,
according to the Center for Responsive Politics, a watchdog group that
tracks campaign finance.

Lobbying and campaign contributions by Massachusetts companies like Biogen
Inc. and Genzyme Corp. are similarly on the rise. And in January,
Millennium Pharmaceuticals of Cambridge was the latest biotech company to
open a Washington office. There are now dozens of lobbyists dedicated
solely to biotech issues, compared to just one for the entire industry 15
years ago.

''The biotech industry has an increasing number of concerns on Capitol
Hill,'' said Bill Shingleton, lobbyist researcher at the Center for
Responsive Politics. ''And as those concerns grow, its lobbying is going to
grow.''

The concerns and the growth have been significant. Biotechnology's agenda
is similar in many ways to that of traditional pharmaceutical companies.
Both have lobbied, for instance, against proposals for prescription drug
benefits in Medicare, fearful that a benefit would give the government
authority to regulate drug prices.

But notable is the divergence of the agendas, in both priorities and issues.
The biotechnology industry worries more about bioethics debates: the
pending decision on federal funding for stem cell research and
congressional legislation to ban human cloning, both of which it supports.
It also puts a greater emphasis on tax issues that affect smaller start-up
companies that, despite the industry's maturity, still hold the sector's
promise for future growth.

''Our bottom line is the effect any legislation will have on our small
emerging companies' ability to raise money. That's a somewhat different
standard than the large pharmaceutical companies use in judging new
legislative and regulatory proposals,'' said Carl Feldbaum, president of
the Biotechnology Industry Organization.

Feldbaum's organization represents 950 biotech companies, academic
institutions and research centers. It now employs a lobbying staff of 14
people, up from just two in 1993.

Other priorities for the biotechnology lobby include:
Protecting intellectual property rights in the hotly contested arena of
patenting genes and proteins, an area in which biotech companies see future
profits.

Strengthening the orphan drug tax credit, which gives breaks to companies
developing drugs targeting a population of fewer than 200,000 patients.
Blocking knockoffs of brand-name biotech drugs. Currently, federal
regulators have no procedure for approving generic versions of so-called
biologics, such as vaccines, genetically engineered proteins, and other
drugs made from living cells - the traditional preserve of the
biotechnology industry.

That issue, which is likely to grow in importance, offers a window on
biotech's new-found clout in Washington.

Senator Orrin Hatch, the Utah Republican who helped author the landmark
Hatch-Waxman Act that provides for generic versions of drugs, has expressed
an interest in updating the law to cover biotech drugs as well as
traditional drugs. But the biotech industry contends that generic versions
of biologics would be less effective and more dangerous because of the
complexity of their products.

''If there's any activity in the area, we'd work to oppose it,'' said Lisa
Raines, senior vice president for government relations at Cambridge-based
Genzyme Corp.

The Generic Pharmaceutical Association, with more than 140 members, has
found itself facing the emerging biotech lobby over the issue. Its
president, William Nixon, estimates it can spend just one-tenth of what the
biotech industry can deploy.

''We don't have the resources,'' he said.
The biotech lobby increasingly does. Amgen, in particular, has proved a
presence in Washington, with a staff of more than a dozen. From 1997 to
1999, its lobbying nearly tripled - from $1.24 million to $3.44 million -
more than all but eight trade groups or traditional pharmaceutical
companies.

The story is similar elsewhere. Genzyme, which opened its Washington office
in 1993, spent nearly $25,000 on campaign contributions during the 1996
election. In 2000, that figure more than tripled to $88,800.
Cambridge-based Biogen spent more than five times more in 2000 than it did
in 1996.

The quality of lobbying has grown, too. In the past year, the Biotechnology
Industry Organization, which once seemed out of its league in some of the
nation's most pressing health care and ethics debates, has brought in
high-profile lobbyists from the law firm Hogan & Hartson and the Health
Insurance Association of America as well as a former chief of staff for
Senator Bill Frist, a Tennessee Republican and doctor.

''The representation of the industry has grown dramatically,'' said Raines
of Genzyme, who in 1986 became the first biotech lobbyist for the
Industrial Biotechnology Association, the predecessor of the Biotechnology
Industry Organization. But, she cautioned, ''the industry is still fairly
young.''

Its political influence may be rising at the right time.
Money has poured into biomedical research, led by the promised doubling of
the budget for the National Institutes of Health, which sets the nation's
medical research agenda. That has meant enthusiasm for companies exploiting
that research, particularly in genomics, and the lobby has been a
relentless supporter of generous NIH funding.

Lobbyists also predict that bioethics issues will gain greater attention in
coming years, increasing the need for a voice to represent the industry.
This summer, the Bush administration is expected to decide on the
contentious issue of whether to make available federal funding for research
into stem cells taken from human embryos. Democratic Senators Edward
Kennedy of Massachusetts and Tom Daschle of South Dakota, meanwhile, are
trying to build momentum on legislation supported by the lobby that would
prohibit employers and insurance companies from using genetic information
to discriminate in hiring, promotions, or health care coverage.

''Congress is starting to get interested in issues that affect
biotechnology,'' said Shingleton, the lobbyist researcher. ''At that point,
they need to make sure they have a Washington presence and that the
industry is heard.''