Codex, Medical Malpractice, FDA Commissioner, and Healthcare
Choice Developments
by Lee Bechtel
National NHF Advocate
September - October 2002, Health Freedom
News
Trade Promotion And Codex Update
On August 6th, President Bush signed into law the trade
promotion legislation (HR 3009) after a House/Senate Conference
committee approved compromise legislation in late July resolving
the differences in House and Senate versions passed earlier this
year. The reconciled legislation includes provisions to help
American workers displaced by international trade to pay for
health insurance while being unemployed and being retrained for
a different job.
Dietary supplement manufacturers have been concerned about the
actions of the CODEX and the United States having to adopt, as a
member of the World Trade Organization (WTO), agreed upon CODEX
“guidelines” in the form of a separate treaty, or as a part of
larger multinational treaties. And, concerned that with the
enactment of the reauthorized trade promotion law (TPA) and
“fast track” Presidential treaty approval the Congress would not
be involved and not be able to prevent the adoption of a treaty
or trade agreement that would adversely impact dietary
supplement manufacturing standards and the US supplement market.
Much of the press and media attention has focused on issue of
allowing the President to submit treaties for Congressional
approval on a straight up-or-down vote without amendments
legislative process. What have not been covered in much of the
reporting are the specific requirements relating to the
involvement of the Congress in drafting and reviewing regular
and fast track trade agreements and treaties.
While the final trade legislation contains provisions that allow
a President to submit treaties for Congressional approval on a
straight up-or-down vote basis, the enacted law spells out the
specifics for the level of Congressional involvement and a
process that must be followed to fit the fast-track approval
standard. The Congressional involvement in the initial drafting
and approval process for a regular or a fast-track international
treaty or trade agreement allows affected industries to present
their concerns and have them addressed before Congressional
approval is granted for final trade or treaty ratification.
The TPA law contains a provision that requires a President to
notify Congress of his intent to enter into an agreement at
least 90 days before signing a treaty or trade agreement. A new
requirement mandates that a President, within 60 days of signing
an agreement, submit to Congress a preliminary list of existing
laws that he considers would be required to bring the United
States into compliance with a trade or treaty agreement. Most
importantly, fast track promotion authority would not apply if
the House and Senate separately agree to a disapproval
resolution within the 60-day waiting period.
The TPA law requires that after entering into a treaty or trade
agreement, the President submit formally the draft agreement,
implementing legislation, and a statement of administrative
action. Congressional committees of jurisdiction can hold
hearings, ‘‘unofficial’’ or ‘‘informal’’ mark-up sessions and a
‘‘mock conference’’ with the Senate committees of jurisdiction
in order to develop a draft implementing bill and to make their
concerns known to the President and the members of his cabinet
involved in treaty negotiations before the treaty approval
legislation is formally introduced and before the Congressional
straight up or down with no amendment process takes place.
Congressional Action On Medical Malpractice Reform Done For
This Year
The Senate on July 30 voted 57-42 to reject an amendment to a
generic drug bill that would have capped damage awards in
medical malpractice lawsuits against doctors and insurers. The
House of Representatives approved similar malpractice reform
legislation earlier this year. President Bush has called on
Congress to pass legislation that would cap malpractice awards.
The amendment, sponsored by Sen. Mitch McConnell (R-KY) would
have limited punitive damages in malpractice suits to twice the
amount of compensatory damages, require that 50% of punitive
damage awards go to state activities, and restrict trial
attorneys' fees. Under the bill, non-economic damages would have
been capped at $250,000. The amendment was favored by
Republicans, who maintain that many doctors have left certain
states, retired early or dropped certain high-risk specialties
because of high malpractice insurance premiums. Senate
Democrats, however, said that the bill "favored the insurance
industry at the expense of victims" of malpractice. Further
action is not expected during the remainder of this
Congressional session given the shorter election year schedule.
White House Health Policy Adviser McClellan Front-Runner for
FDA Commissioner
Dr. Mark McClellan, a member of President Bush's Council of
Economic Advisers, has emerged as the leading candidate to take
over as commissioner of the Food and Drug Administration (FDA).
The position has been vacant since Bush took office. McClellan,
a physician and economist, has been a "loyal champion" of the
White House's health care proposals, including its versions of a
Medicare prescription drug benefit and discount drug card
program. In addition, he does not appear to have any links to
the pharmaceutical industry, an issue that Democrats on the
Senate Health, Education, Labor and Pensions Committee (HELP)
have said would be a concern. This committee has jurisdiction
over the confirmation of the FDA Commissioner.
Most recently, McClellan was a professor of economics and
medicine at Stanford University. Lester Crawford, director of
food and nutrition research at Virginia Polytechnic Institute,
has filled the FDA position, which requires Senate confirmation,
on a temporary “Acting Commissioner” basis. White House
officials said that the timing of an announcement about a
possible McClellan nomination is uncertain.
Recommendations To Expand Healthcare Treatment Choices
The Integrated Healthcare Policy Consortium (IHPC) has issued
its final report of recommendations to be made to the Congress
and federal agencies in regards to changes in federal health
care policy to advance the availability of integrated
complementary and alternative medical care. Key report
recommendations are to establish a federal office to foster the
creation of an integrated healthcare (IHC) system focused on
health promotion and disease prevention; significantly increase
federal research allocations for health promotion and disease
prevention, and examine the role of CAM and integrated
approaches in health promotion and disease prevention; to
establish a national consortium of conventional and CAM
educators and medical practitioners; to assure widespread access
to CAM/IHC in rural areas and under served communities; to
achieve regulatory recognition for each alternative medical care
profession seeking it in every state and within federal health
programs; to develop a national agency that acts as a
clearinghouse for defining the qualifications and scope of
medical practice for healthcare providers in each discipline,
system or modality; and, to ensure that complementary and
alternative medicine (CAM) is effectively integrated into the
federal government’s Healthy People 2020 program. The complete
final report, “National Policy Dialogue Final Report", can be
viewed on the American Association for Health Freedom (AAHF)
website at:
Guidelines for Complementary and Alternative Medical Practice
The Federation of State Medical Boards (FSMB) recently released
a policy/position paper entitled "Model Guidelines for the Use
of Complementary and Alternative Therapies in Medical Practice",
and is asking all state medical boards to adopt the guidelines.
The guidelines allow a wide degree of latitude in physicians’
exercise of their professional judgment and do not preclude the
use of any methods that are reasonably likely to benefit
patients without undue risk. They recognize that there are
varying degrees of potential patient harm that can result from
either conventional medical practices or complementary and
alternative medical therapy (CAM) practices. The guidelines
recommend that State Medical Boards recognize that the standards
used in evaluating health care practices should be consistent,
whether such practices are regarded as conventional or CAM and
that licensed physicians not be found guilty of unprofessional
conduct solely on the basis of utilizing CAM treatment
modalities. The guidelines can be viewed on FSMB website at:
