Drug Development Act of 2005)
by Lee Bechtel, NHF Lobbyist
February 2006
Update:
Late December President Bush signed H.R.2863 into law. This
bill,
like S.1873 would have done, will limit liability for vaccine
and drug
manufacturers in times of public health or bioterror
emergency. However,
with the help of NHF members, and other opposing groups,
further sections of
S.1873 that the pro-pharmaceutical lobby had wanted to include
in H.R.2863
were not included. For example, it did not include the
creation of a new
federal agency to coordinate, support and accelerate the
production of
vaccines and drugs for use as biodefense and pandemic
countermeasures, and
nor did it grant special tax breaks for drug companies.
Subsequently, on February 15, Congressional Democrats
introduced legislation
that would roll back some of the limited liability provisions
of H.R.2863. A
group of 21 US Senate and House Democrats led by Sen. Edward
Kennedy (D-MA)
have said that current provisions are too broad and could be
abused by
manufacturers to avoid liability. They also said provisions
defined health
emergencies too broadly and left injured people with no
compensation.
H.R.2863 has three sections (divisions). Division C (i.e.
section 3) of the bill is the Public Readiness and Emergency
Preparedness Act. This division is based upon, and is an
edited version of, the equivalent section of S.1873. On
December 22, 2005, Congress approved the "Public Readiness and
Emergency Preparedness Act" as part of the unrelated Defense
Appropriations bill. The legislation was muscled through
Congress in the dead of the night, in violation of
Congressional Rules and without debate. Tucked away in the
massive Defense spending bill was a section called "Division
E", the "Public Readiness and Emergency Preparedness Act"
which grants immunity to drug companies from liability for
injuries caused by their products, if the Secretary of HHS
declares that such products are "covered countermeasures."
We therefore ask that you contact your Senators and demand the
rolling back
of the limited liability provisions for vaccine and drug
manufacturers in H.R.2863.
Senate Majority Leader Bill Frist (R-Tenn) is planning to add
this bill, as an amendment, to the 2006 Department of Defense
Appropriations conference report bill. This is one of two must
pass bills pending in Congress. A Senate vote is expected
before the Congress recesses for Christmas, around December
20th.
The letters of NHF members and other groups have had an impact
on the expected passage of the Senate bill, S 1873, the
Biodefense and Pandemic Vaccine and Drug Development Act of
2005. The NHF opposes this bill because it would provide
pandemic flu vaccine makers with broad liability protections.
It would prevent manufacturers from being sued unless willful
misconduct is proven. The bill would also preclude the
creation of a compensation fund for any injuries vaccine users
may suffer.
A coalition of Democrats, led by Senators Edward Kennedy
(D-MA) and Christopher Dodd (D-CT) are working to defeat the
liability waiver. Groups are also targeting Senator Arlen
Spector (R-PA). Senator Specter is key to defeating the bill
because he is more likely, than any other Republican Senate
conferees (a conferee is a member of the temporary Committee,
which is a joint House and Senate committee with the
responsibility to resolve differences between bills passed by
the House and Senate), to oppose the Biodefense and Pandemic
Vaccine bill on the Senate floor.
NHF member's letters in opposition to this bill are helping to
have an impact on defeating this Senate bill. NHF members who
previously e-mailed their Senators, should do so again, and
are encouraged to send an opposition letter to Senator Spector.
NHF members, who have yet to correspond with their Senators in
opposition, are encouraged to do the same to help defeat this
legislation.