ACP: Governmental Affairs and Public Policy - Letter to HHS Secretary Thompson Urging the Federal Government to Ensure That an Adequate Supply of the Flu Vaccine is Reaching Internists and Other Primary Care Physicians

Advocacy

Letter to HHS Secretary Thompson Urging the Federal Government to Ensure That an Adequate Supply of the Flu Vaccine is Reaching Internists and Other Primary Care Physicians

October 26, 2004

The Honorable Tommy G. Thompson,
Secretary of the Department of Health and Human Services
Hubert H. Humphrey Building
200 Independence Avenue, S.W.
Washington, DC 20201

Dear Mr. Secretary:

On behalf of the American College of Physicians, representing more than 116,000 doctors of internal medicine and medical students, I am writing to urge the federal government to take additional steps in addressing misdistribution and shortages of influenza vaccines. ACP is gravely concerned about the impact these recurring shortages will have on the nation's health.

Influenza, on average, results in 36,000 deaths and more than 200,000 hospitalizations each year in the U.S. Rates of serious illness and death are highest among people over age 65, people who have chronic medical conditions that place them at increased risk for complications from influenza, and children under 24 months. Since the majority of our patients fit into the first two categories, it is critical that physicians of internal medicine have access to an adequate supply of flu vaccine.

The current influenza vaccine shortage highlights many of the shortcomings of our existing system, including a lack of incentives and legal protections for manufacturers to produce vaccines and a reliance on outdated technology. Additionally, our national distribution system fails to ensure that high-risk patients will have access to vaccines first.

ACP appreciates that the DHHS is taking positive steps to address the current problem and keep the public informed of measures to prevent and treat the flu. We are pleased that a task force has been created to ensure that the flu vaccine and treatment medication goes to those who need it most and without any price gouging. We are also pleased that it includes members of the public health community, physicians, law enforcement and prosecutors, trade associations and advocacy groups. ACP thanks the CDC and Aventis Pasteur for working to identify providers of high-priority populations, including primary care and specialty physicians. Finally, ACP appreciates that Congress recently passed a bill to shield flu vaccine manufacturers from lawsuits, while assuring victims compensation for injuries.

Despite these positive efforts, ACP is concerned that our nation lacks a permanent mechanism to ensure that vaccines reach internists and other primary care physicians who have been clearly identified as providers who care for high-risk patients. To improve our nation's vaccination efforts and ensure that patients most in need can continue to access vaccines, ACP makes the following recommendations for immediate action and offers additional steps for the future:

Recommendations for Immediate Action

Manufacturers of the influenza vaccine, non-professional distributors of the vaccine, and appropriate government agencies should ensure that limited supplies of the vaccine are made available to clinicians and other licensed health care providers who provide regular patient care to high-risk individuals.
- The CDC should continue to recognize the role of physicians of internal medicine in treating a disproportionately large number of seniors and patients with multiple, chronic conditions-- two patient categories that have historically been labeled by the CDC as high-risk. For many vulnerable patients, the physician's office is the best location to be immunized, especially for patients who are unable to stand in line at grocery and drugstores and who require careful monitoring.
Local public health departments should have an aggressive plan in place to distribute vaccine to local providers with the greatest need.
States should thoroughly investigate reports of price gouging involving the flu vaccine and prosecute those found to be taking advantage of the vaccine shortage.
To comply with emergency orders issued by state or local governments mandating vaccine be administered only to persons of high risk, physicians should have access to clearly communicated prioritization requirements, distribution plans, and other instructions. Physicians should not be penalized for failure to follow emergency orders that are not clear and timely and do not provide for due process to resolve situations outside the physician's control.

Additional Recommendations

The CDC should be given the authority to organize the distribution of vaccines and implement a concentrated response system, particularly in emergency situations. Distribution plans should be formulated by the CDC prior to the start of a flu season. U.S. officials should not be scrambling for ways to modify the distribution system to make up for shortages as the flu season begins, as is the case this year.
- A vaccine clearinghouse should be established to facilitate donation of vaccine to individuals at high risk of infection.
- The DHHS should be permitted to purchase vaccine from employers or wholesalers who are willing to sell it.
Additional research and development to improve surveillance of strains and outbreaks and to improve current vaccine production methods should be encouraged.
- Research funding should be increased to help develop alternatives to egg-grown influenza vaccines.
The federal government should be required to build and maintain a six-month stockpile of prioritized vaccines to prepare our nation for vaccine shortages.
The federal government should offer incentives to encourage more manufacturers to research and produce vaccines, such as tax incentives for vaccine manufacturers to expand production capabilities and guarantees that the government would purchase unused supply.
Funding available for state and local efforts should be expanded to boost immunization rates among adults and adolescents who are underserved or at high risk for vaccine-preventable diseases.
- Funding should be authorized under the Public Health Service immunization program for the distribution of influenza vaccine to qualifying health care providers, including internists.
Increase education and outreach efforts for upcoming flu seasons.
Revise provisions governing the Vaccine Injury Compensation Program (VICP) to ensure that unwarranted litigation does not further destabilize our vaccine supply.
Vaccines manufactured abroad should only be used in the U.S. if the FDA has certified their safety.

For many years, unavailability of vaccine products has presented a challenge to physicians and patients. The federal government must have a vaccine production and distribution system in place to assure an adequate and safe supply of lifesaving vaccines for all individuals, but particularly our most vulnerable patients. Attached is a more comprehensive statement by the College on this issue. We hope you find this informative and we look forward to working with you on this critical issue.

Sincerely,

Charles K. Francis, MD, FACP, FACC
President