On April 17, the AAFP and 13 other organizations sent a letter(4 page PDF) to leaders of the House Committee on Energy and Commerce voicing concerns about immunization-specific provisions in a discussion draft of the 21st Century Cures Act(energycommerce.house.gov) the committee released Jan. 27.
(Editor's Note: The committee's discussion draft was updated April 29,(energycommerce.house.gov) but the language regarding immunizations remains intact.)
In April of last year, two Energy and Commerce Committee members -- Chair Fred Upton, R-Mich., and Diana DeGette, D-Colo. -- launched the 21st Century Cures initiative to promote a conversation on how to accelerate processes involving medical treatments in the United States from discovery through development to delivery. Policymakers organized eight hearings and a dozen roundtables to collect feedback from health care stakeholders, including patient advocates, manufacturers, medical associations and research organizations. The discussion draft included much of this feedback.
A white paper(energycommerce.house.gov) on the discussion draft outlines its goals:
- The AAFP and 13 other organizations recently sent a letter to the House of Representatives Committee on Energy and Commerce voicing concerns about immunization-specific provisions in a discussion draft of the 21st Century Cures Act.
- Concerns include imposing rigid deadlines for the CDC's Advisory Committee on Immunization Practices (ACIP) recommendations, requiring additional transparency for ACIP research and recommendation processes, and calling for the CDC to meet with vaccine industry officials during set timeframes.
- The letter explains that the process of developing, approving and recommending vaccines for use in the general public is a "carefully calibrated system designed to explore the safety and efficacy of immunizations as thoroughly as possible before widespread use occurs."
- incorporate patient perspectives into the regulatory process and help address unmet medical needs,
- build the foundation for 21st century medicine,
- streamline clinical trials,
- support continued innovation at federal public health agencies, and
- modernize medical product regulation.
But the Academy and the other signatories on the letter are concerned about language in the draft that imposes rigid deadlines for the CDC's Advisory Committee on Immunization Practices (ACIP) recommendations, requires additional transparency regarding ACIP research and recommendation processes, and calls for the CDC to meet with vaccine industry officials during set timeframes and notify them of each change with a vaccine's data review.
In their letter, the groups explain that the process of developing, approving and recommending vaccines for use in the general public is a "carefully calibrated system designed to explore the safety and efficacy of immunizations as thoroughly as possible before widespread use occurs."
"Recognizing the well-established, deliberate, methodical nature of this system, we would like to express our concerns about provisions of the discussion draft that could disrupt this balance by imposing rigid requirements and deadlines for action," the letter reads. "It is unclear whether the Committee has identified a particular issue or problem these provisions are intended to address. In the absence of such an issue, however, we would urge tremendous caution in pursuing changes that could introduce instability or the appearance of impropriety into the existing successful framework."
Imposing Rigid Deadlines for ACIP Recommendations
The letter first addresses the discussion draft's proposal to establish standard timelines for the ACIP to "consider and make recommendations with respect to the route of administration, dosage and frequency of administration of vaccines for specified populations."
"The imposition of 'standard timelines' would fail to recognize the fact that data is sometimes not forthcoming during those time periods and could force the ACIP to take votes based on incomplete information," the letter reads. "In those situations, it seems logical to assume that the body would err on the side of caution and not recommend a vaccine for wider use. This could, in turn, delay the availability of important vaccines to those who would benefit from them."
The letter goes on to explain that the ACIP's evidence review is complex and often iterative and includes examining data not always related to population groups for whom the vaccine was initially licensed by the FDA. For example, it says for influenza and pertussis vaccines licensed for adults, the ACIP also examined and recommended their use for pregnant women separately.
It also states that establishing set deadlines doesn't take into account that every vaccine is not recommended for population-wide use. So if a vaccine is developed for a common health issue, but that issue doesn't pose a public health threat, the vaccine would fail to meet the standard for ACIP consideration.
Requiring Additional Transparency
The 21st Century Cures Act discussion draft also addresses the transparency of the ACIP. But the letter explains that the organization already is considerably transparent; its meetings are open to the public and are webcast, and its meeting materials are posted online before and after meetings. Public input is welcomed at multiple points, and presentations about studies and data frequently are delivered by industry representatives.
"At the same time, it is vitally important that the ACIP be free of either the appearance or the actuality of undue influence by any party," the letter reads. It explains that interested parties are strongly discouraged from contacting ACIP members individually about committee business. And the ACIP also has confidential conversations, including within its work groups, to avoid influencing markets or economic interests.
Regarding a proposal in the discussion document to require consistent criteria to evaluate all vaccines, the letter explains that using the same criteria for vaccines would "be significantly hampered by the fact that vaccines may involve very different target populations, aspects of the immune system, public health burden, quality of data and other factors."
"An attempt to impose a cookie-cutter approach on vaccine evaluation would risk forcing the ACIP to give inappropriate weight to various factors, depending on the vaccine and disease involved," the letter reads.
Directing CDC Interaction With Industry
Finally, the draft document would require the CDC to meet with vaccine industry officials within certain timeframes; provide specific, detailed information to industry; and "promptly notify" the vaccine developer any time the agency becomes aware of information that might have implications for the vaccine developer's research and development.
"The requirement that the CDC respond to a meeting request within a rigid deadline could divert precious resources from other, more urgent public health needs," the letter reads.
Moreover, the mandate to provide specific, detailed information to industry officials raises a number of questions and concerns:
- Should the CDC be responsible for packaging publicly available information for the industry?
- If the CDC has access to nonpublic or preliminary information or data, must that be shared?
- Is it the CDC's responsibility to track industry interests so that it can determine when a change in data or evidence may have implications for a manufacturer's product in development?
In addition to today's release of an updated discussion draft, the Energy and Commerce Committee's Health Subcommittee will hold a legislative hearing April 30 to further review the proposal. Background materials are available online.(energycommerce.house.gov)
The AAFP will review the new proposal and provide expert commentary in the coming weeks.
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