[Peace-discuss] Drug Company Lobbying

[Barbara Dyskant]

Hi, 

Here's an interesting article-- the New York Times reported that drug
companies
are lobbying Congress to exempt them from quality control standards for
medicines, AND from having to inform the government if there are serious
illnesses or complications resulting from use of their medicines, AND want to
be insured by the government ("meaning the taxpayers) in a way similar to
coverage of nuclear power plants happens.  They've been carefully writing  up
the exact language of the legislation they want.  

Here's a choice excerpt from this article:

Drug companies and the Bush administration have told Congress that rules of
the
Food and Drug Administration may interfere with the production of drugs and
vaccines needed in a public health emergency. So, they say, the secretary of
health and human services should be able to waive those rules to ensure that a
sufficient supply of drugs will be available.
When asked for examples, administration officials said they might want to
suspend rules for the testing and labeling of drugs, vaccines, blood and blood
products. Also, they said, the government may want to waive quality-control
standards, "good manufacturing practices" and rules that require drug
makers to
notify the government of any serious illness or injury caused by the use of
their products


And here's the "whole" article, in case you'd like to read on.

Lobbyists Seek Special Spin on Federal Bioterrorism Bill
December 11, 2001 
By ROBERT PEAR

WASHINGTON, Dec. 10 - In the final hectic days before 
Congress adjourns for the year, lobbyists are swarming 
around the Capitol, trying to adorn a bill on bioterrorism 
with all sorts of special-interest provisions. 
Profit-making hospitals are trying to qualify for federal 
disaster assistance, now available only to nonprofit 
groups. 
Biotechnology companies want the government to protect them 
against lawsuits over injuries caused by use of their 
products. 
Drug companies want an exemption from the antitrust laws so 
they can work together to develop, produce and sell drugs 
and vaccines against anthrax, smallpox and germ warfare 
agents. 
House Republican leaders said today that the $3 billion 
bioterrorism bill would reach the House floor this week, 
perhaps on Tuesday. The Senate is expected to act on it 
before the end of the year. 
With support from the drug and biotechnology industries, 
Bush administration officials are asking Congress to let 
them suspend drug safety and testing requirements in the 
event of a bioterrorist attack or other emergency to rush 
potential treatments to affected areas. 
Lobbyists have supplied Congress with the precise 
legislative language they want to see written into law to 
favor the interests they represent. 
They are focusing on members of both parties, since 
Republicans and Democrats have worked together in writing 
legislation to defend the nation against bioterrorism. 
The effort has been led by two Republicans, Senator Bill 
Frist of Tennessee and Representative Billy Tauzin of 
Louisiana, and two Democrats, Senator Edward M. Kennedy of 
Massachusetts and Representative John D. Dingell of 
Michigan. 
Under current law, only state and local governments, 
individuals and private nonprofit organizations can receive 
federal disaster assistance. The Federation of American 
Hospitals, which represents investor- owned hospitals, 
wants to redefine "private nonprofit facility" to include 
"private for-profit medical facilities." 
Charles N. Kahn III, president of the federation, said 
for-profit hospitals should have access to federal money 
because "they provide critical community services in an 
emergency." Dan Boston, a lobbyist for the federation, 
said: "Disaster strikes without regard to hospital 
ownership. In many markets, for- profit hospitals serve as 
the safety net or sole community providers." 
Some state and local officials and nonprofit groups object 
to the change. Federal aid is limited, they say, and the 
people who are now eligible will receive less if for-profit 
hospitals get some of the money. 
Moreover, some members of Congress say, if for-profit 
hospitals and nursing homes can qualify, then electric 
power companies, gas companies and other investor-owned 
utilities can use the same argument to insist that they too 
should get federal disaster assistance. 
Lobbyists for Tenet Healthcare, a for-profit company, told 
Congress that the current ban on aid to for- profit 
hospitals was unfair and anticompetitive. Profit-making 
hospitals cannot get federal disaster aid, Tenet said, but 
"their nonprofit competitors are building new hospitals 
with federal money - the very taxpayer dollars that the 
for-profit institutions pay into the Treasury." 
Biotechnology companies are lobbying Congress and the White 
House on another important issue in the bioterrorism bill. 
They want the government to defend them in court and pay 
claims for injuries caused by the vaccines they make to 
protect people against toxins and "biological agents." 
"A small company can be wiped out by litigation if it is 
not indemnified" by the government, said Stephan A. Lawton, 
vice president of the Biotechnology Industry Organization. 
Legislation drafted by the industry would require the 
government to "indemnify and defend" any federal contractor 
who produced drugs or vaccines to combat bioterrorism. 
The biotech industry wants the government to limit its 
liability, just as a 1957 law, the Price-Anderson Act, 
limits liability for nuclear accidents resulting from the 
operation of nuclear power plants. 
The bill drafted by biotech lobbyists would prohibit 
punitive damages and would set a $250,000 limit on damages 
for pain and suffering and other noneconomic losses, like 
the death of a loved one. 
The industry argues that such limits on liability would 
encourage companies to develop vaccines and other products 
to combat terrorism. 
Likewise, drug companies have been asking Congress for some 
relief from antitrust laws, to make clear that they could 
work together on certain projects. 
Under the Frist-Kennedy bill, the Justice Department could 
grant drug companies an exemption from the antitrust laws 
so they could collaborate in the testing, manufacture and 
sale of drugs and vaccines needed to cope with the threat 
of bioterrorism. 
At the same time, lobbyists are fighting over a proposal 
that would require makers of drugs and medical devices to 
put bar codes and universal product numbers on their 
products. 
Hospital executives and federal officials say the bar codes 
would speed the delivery of drugs and reduce the chances 
that the wrong item might be dispensed. But some 
manufacturers of drugs and medical devices have urged 
Congress to reject the proposal, saying it would increase 
their costs and might be used by the government to set up 
some type of fee schedule. 
Herb Kuhn, a lobbyist for Premier Inc., a group purchasing 
agent for nonprofit hospitals, said the bar codes would be 
a boon to hospitals, making it easier for them to compare 
the prices and effectiveness of drugs and medical devices. 
Drug companies and the Bush administration have told 
Congress that rules of the Food and Drug Administration may 
interfere with the production of drugs and vaccines needed 
in a public health emergency. So, they say, the secretary 
of health and human services should be able to waive those 
rules to ensure that a sufficient supply of drugs will be 
available. 
When asked for examples, administration officials said they 
might want to suspend rules for the testing and labeling of 
drugs, vaccines, blood and blood products. Also, they said, 
the government may want to waive quality-control standards, 
"good manufacturing practices" and rules that require drug 
makers to notify the government of any serious illness or 
injury caused by the use of their products.





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