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AMA
Votes to Support Conditional Drug Importation, Stop Medicare Pay Cuts
Dec. 7,
2004 - The American Medical Association voted yesterday to support the
importation of prescription drugs by wholesalers and pharmacies, if
certain conditions are met to ensure patient safety. They also adopted
a policy aimed a curbing further cuts in Medicare payments to
physicians.
Following are the conditions for importation of drugs adopted by the
AMA.
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-- All
drug products are Food and Drug Administration (FDA)- approved and meet
all other FDA regulatory requirements;
-- the
drug distribution chain is "closed," and all drug products are subject
to reliable, electronic track and trace technology; and
--
Congress grants necessary additional authority and resources to the FDA
to ensure the authenticity and integrity of imported prescription drugs.
The AMA
reiterated its strong opposition to personal importation of prescription
drugs via the Internet until patient safety can be ensured.
"America's physicians write more than three billion prescriptions a year
for patients -- and we need to know that when patients fill those
prescriptions the drugs they take are safe, said AMA Trustee Edward L.
Langston, MD. The American Medical Association believes that
prescription drugs should be available at the lowest price possible, and
we must ensure quality and safety."
"Patient safety must remain the overriding concern as we work to make
prescription drugs more available and affordable for patients. Patients
must be protected from unapproved drugs that could be unsafe, expired,
counterfeit, adulterated, misbranded or inappropriately labeled.
The AMA
also voted to educate its members regarding the risks and benefits
associated with drug importation and reimportation efforts. In addition,
AMA will review the recommendations of the forthcoming report of the
Department of Health and Human Services (HHS) Task Force on Drug
Importation and, as appropriate, revise its position on whether or how
patient safety can be ensured under legalized drug importation.
The
effort to stop further cuts in Medicare physician payments was one of
several new policies approved at the meeting. Following are the
statements on each one issued by the AMA press office.
MEDICARE CUTS: Extremely concerned about predictions that the current
flawed Medicare payment formula that sets reimbursement rates for
physicians and other health professionals will cut Medicare payments by
31 percent over eight years, the AMA today voted to continue to assign a
top priority to preventing more Medicare payment cuts. The AMA will work
to replace the formula with payment updates that reflect increases in
the cost of medical practice to help ensure access to medical care for
our nation's seniors.
CONFIDENTIALITY OF PEER REVIEW PROCESS: In the interest of rigorous peer
review to ensure patient safety, the AMA voted to seek federal
legislation to prohibit discovery of records, information and documents
obtained during the course of professional peer review proceedings.
Federal and state courts around the nation have consistently held that
meaningful peer review occurs only if it is confidential, encouraging
full candor and full, frank evaluation in the peer review process.
Earlier this year, Amendment 7, supported by the Academy of Florida
Trial Lawyers, passed in Florida. If fully implemented, Amendment 7 will
eliminate confidentiality from the peer review process and undermine the
entire process.
REALITY
TV: Reality television shows that depict surgery should not minimize the
seriousness and risks of surgery and distort patient expectations, the
AMA said today. "It is a physician's ethical responsibility to
accurately and openly discuss the risks and benefits of any treatment,
including surgery," said AMA Trustee Ronald Davis, MD. "These reality
shows need to follow the same ethical principles." In a related matter,
the AMA asked its Council on Ethical and Judicial Affairs to further
study the issue and prepare an opinion on physician participation in
television entertainment programs.
CLINICAL TRIAL GAG CLAUSES: Concerned that industry sponsorship of
scientific studies is restricting the availability of relevant
information, the AMA voted today to take action to allow physicians to
present scientific findings free of corporate interference.
Clinical trials are the primary means to evaluate the efficacy and
safety of new drugs and other medical technologies. Currently, 75
percent of all funding for clinical trials in the United States comes
from corporate sponsors. When published in peer-reviewed journals, the
results of these studies provide a scientific basis for treatments
physicians provide to patients. Patient care is endangered when
physician researchers are prevented from presenting information from
industry-funded studies, the AMA said.
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