Nine months after
President Bush’s nomination, the U.S. Senate
confirmed Andrew von Eschenbach to run the FDA with a
vote of 80-11. His nomination faced objections from
several Republican senators, stemming from issues
surrounding an investigation into the antibiotic Ketek
(which is linked to liver failure), safety concerns
over the abortion pill RU-486, and the Bush
administration’s stance against prescription drug
importation.
A Tufts CSDD study says
it costs more (about $1.2 billion) and takes longer to
get a complex biologic therapy onto the market
compared with traditional drugs. Biotechs face
mounting criticism about the rising cost of new
biologics. A new Democratic majority in Congress will
likely make reducing healthcare costs a priority.
Bills that would create a legal framework allowing
generic versions of biologics in the United States
have been put forth.
As Democrats took
control of Congress for the first time in a dozen
years, an Associated Press-AOL News poll showed public
support for their top goals. The poll found 69% of
adults favor the government taking steps to make it
easier to buy prescription drugs from other countries,
and about 56% of adults support easing restrictions on
using federal money to pay for embryonic stem cell
research.
As a whole, the
pharmaceutical sector enjoyed modest growth in 2006.
Year to date, as of December 28, 2006, the American
Stock Exchange’s Pharmaceutical Index had risen
8.2%. The index’s best performer in 2006 was Merck
& Co. with a 37% increase. Teva Pharmaceutical
Industries fared the worst, with losses of 27%.
A Government
Accountability Office report found that annual R&D
spending by the pharmaceutical industry increased
147%, to $60 billion, between 1993 and 2004. At the
same time, the number of new drug applications to the
FDA grew by only 38%. About two-thirds of the new
applications were for drugs representing modifications
to existing medicines, while 32% were for potentially
innovative new drugs.
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