AMA Backs Drug Importation, Under Stringent Criteria
Drug importation, availability of flu vaccine, and the ethics of specialty hospitals dominated debates at last month's interim meeting of the AMA's House of Delegates in Atlanta.
Up till now, the AMA has opposed the importation and reimportation of drugs into the United States. The house voted to revise that position if the report of the Health and Human Services Task Force on Drug Importation indicates that patient safety can be ensured under legalized conditions.
That report, released at press time, states that commercial importation by large wholesalers could be possible under certain stringent conditions: that the Food and Drug Administration (FDA) is given resources to ensure safety; that the drugs being imported are high-cost, high-demand drugs; and that there is a closed distribution chain with a traceable “pedigree” to track where the drugs have been. However, the report recommends against private importation of drugs by individuals.
The AMA is reviewing the report. Details about the report and the AMA's reaction will appear in the next Psychiatric News.
The conditions for importation spelled out by AMA delegates at last month's meeting closely resemble those listed by HHS. They are as follows:
All drug products are approved by the FDA 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. | |||||
Congress grants necessary additional authority and resources to the FDA to ensure the authenticity and integrity of imported prescription drugs. | |||||
“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, M.D. “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 house also voted to educate AMA members regarding the risks and benefits associated with drug importation and reimportation.
Addressing this year's critical flu vaccine shortage, the house considered several new policies to prevent or mitigate future vaccine shortages. During an education summit, Julie Gerberding, M.D., M.P.H., director of the Centers for Disease Control and Prevention (CDC), reviewed new preventive strategies for a national influenza outbreak.
“This year's shortage of the flu vaccine was a wake-up call,” AMA President John C. Nelson, M.D., M.P.H., said. “We can use what we've learned from this year's flu vaccine shortage to help enact overall improvements in the way we deliver all vaccines. Flu vaccination provides a platform from which we can improve the nation's immunization system. Development of an adult immunization system to obtain and deliver all vaccines is needed to improve preventive care and public health preparedness.”
House delegates passed several policies that support ongoing AMA flu vaccine efforts, through such initiatives as the National Influenza Vaccine Summit. The new policies call for the AMA to do the following:
Support the development of a strong adult and adolescent immunization program in the United States. | |||||
Work with its partners in immunization and other appropriate stakeholders, such as those in the National Influenza Vaccine Summit, to develop recommendations on the best methods for achieving a strong adult and adolescent immunization program in the United States. | |||||
Continue collaboration with the CDC and other stakeholders to work to achieve the influenza immunization goals of Healthy People 2010, with particular attention to improving demand for vaccine and achieving stability in the vaccine supply. | |||||
Advocate for and support programs that ensure the production, quality, and timely distribution of those vaccines recommended by the CDC to the U.S. population at risk. The AMA also called for physicians to be allowed to form purchasing alliances for competitive purchasing of influenza vaccine comparable to large purchasers that currently supply pharmacy and grocery chains with influenza vaccine. | |||||
A subject of sometimes contentious debate was the role of specialty hospitals—physician-owned ambulatory care facilities offering select services—in local communities. Physicians claiming that specialty hospitals offer access to quality services unavailable at community hospitals were pitted against those who maintain that such facilities are luring the most lucrative business away from community hospitals.
After prolonged debate, delegates approved a report that calls on the AMA to support and encourage competition between health care facilities as a means of promoting the delivery of high-quality care and to oppose efforts to extend the current 18-month moratorium on physician referrals to specialty hospitals imposed by the Medicare Modernization Act.
But house delegates also added the recommendation that the AMA should“ encourage physicians who contemplate formation of a specialty hospital to consider the best health interests of the community they serve.... Physicians should explore the opportunities to enter into joint ventures with existing community hospitals before proceeding with the formation of a physician-owned specialty hospital.” ▪
