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General Positions
The following are the Coalition's official positions on several important issues currently affecting the free exchange of scientific and medical information. See also individual position papers listed on the main page of this section.
FDA REFORM
It is the Coalition's position that a strong and efficient FDA is vital to our nation's health.
It is the Coalition's position that the functions of approving new drugs and monitoring the marketing of existing drugs should be separated in order to eliminate the implicit threat of withholding drug approval where there is a disagreement over marketing questions concerning other products from the same manufacturer.
The Coalition believes that CME and the exchange of scientific information should be governed by the scientific community, beyond the FDA's purview.
It is the Coalition's opinion that the FDA's definition of "labeling" should be narrowed to conform to the intent of the 1962 Kefauver-Harris legislation and should not encompass all communications issued or underwritten by the regulated industry.
Lastly, the Coalition believes that the provisions of the Kefauver-Harris Act that regulate advertisements to the medical profession, which are themselves antiquated, are inappropriate for advertising in consumer media. The "Brief Summary" in prescription advertising needs to be revised or replaced with a view toward logic, brevity and readability.
DISSEMINATION OF OFF-LABEL INFORMATION
The Coalition supports the right of healthcare companies to distribute truthful, scientific information. The Coalition therefore supported the Washington Legal Foundation (WLF) in its suit against the FDA's practice of restricting dissemination of medical literature and text books.
It is the Coalition's opinion that companies should be allowed to disseminate articles and text books containing off-label information if the material is:
- Truthful and not misleading
- Peer reviewed
- Independently produced
- Unabridged
- Clearly identified as off-label
- Clearly identified with sponsorship
- Reveals the relationship between author and sponsor
- Inclusive of official labeling
The Coalition believes that with adoption of these principles the public good will be better served with information about scientific advances reaching the public and implemented at the earliest possible date.
(See guidelines for distribution of off-label drug information under "Position Papers" on this site.)
CONTINUING MEDICAL EDUCATION
It is the Coalition's position that the rules governing the continuing education process are the purview of the scientific and academic community and that government should not be involved in the process.
Further, it is the Coalition's belief that artificial and arbitrary restrictions on the continuing education process by government or academia impede the advance of science.
DIRECT-TO-CONSUMER (DTC) ADVERTISING
Today's consumers demand to be informed about healthcare options. The FDA has proposed a flexible approach to advertising of prescription drugs to the consumer with its proposed guidelines on broadcast advertising. The Coalition supports this approach, although it believes that the "Adequate Provision" section is more extensive and costly than necessary. We believe provision of an "800" number and an Internet site, in addition to professional counsel, provide sufficient coverage and balance.
Further, we believe that it is vital that all DTC advertising be preceded by corresponding communication with healthcare professionals (the learned intermediary).
In the Coalition's opinion, both benefits and potential risks should be discussed in DTC advertisements and the current "Brief Disclosure" for print advertisements should be replaced by a "see your healthcare provider for important information" statement.
In short, we believe that the best source of prescription drug information for the consumer is the learned intermediary.
THE INTERNET
It is the Coalition's position that existing regulations on advertising and labeling are applicable and also adequate for the Internet and that additional regulations are not necessary. Adherence to the following principles should suffice to meet any FDA concerns on the Internet:
- Brief or full disclosure should be accessible on every page where promotion appears.
- Fair balance should be provided within the limitations of the computer screen and the Internet scrolling page.
- Linking from sites prepared by the pharmaceutical industry should be allowed. With certain limitations, companies should be permitted to post investigational information.
- International demarcations should be made by clearly identifying the country for which the information is intended.
- Chat rooms and news groups sponsored by a company should be conducted under the same rules as CME activities, possibly overseen by an Accreditation Council for Continuing Medical Education (ACCME)-accredited provider.
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