200707

Patient Access to Treatments
Prescribed by Their Physicians
POSITION STATEMENTS

Approved by the Board of Trustees, July 2007
Approved by the Assembly of District Branches, May 2007

              "Policy documents are approved by the APA Assembly and Board of Trustees… These are …position statements that define APA official policy on specific subjects…"     APA Operations Manual             

The APA affirms strong support for the autonomous clinical decision-making authority of a physician and for a physician’s lawful use of an FDA-approved drug product or medical device for an unlabeled indication when such use is based upon sound scientific evidence in conjunction with sound medical judgment; APA further affirms that when the prescription of a drug or use of a device represents safe and effective therapy, third party payers, including Medicare, should consider the intervention as reasonable and necessary medical care, should fulfill their obligation to their beneficiaries by covering such therapy, and should be required to cover appropriate "off-label" uses of drugs on their formularies. The APA recommends the following:

Prescribing and Reimbursement for FDA-Approved Drugs and Devices for Unlabeled Uses

(1) APA reaffirms the following policies: (a) A physician may lawfully use an FDA-approved drug product or medical device for an unlabeled indication when such use is based upon sound scientific evidence and sound medical opinion;  (b) When the prescription of a drug or use of a device represents safe and effective therapy, third party payers, including Medicare, should consider the intervention as reasonable and necessary medical care, irrespective of labeling, and should fulfill their obligation to their beneficiaries by covering such therapy;  and (c) APA encourages the use of three compendia (AMA's Drug Evaluations*; United States Pharmacopeia-Drug Information, Volume I*; and American Hospital Formulary Service-Drug Information) in conjunction with the peer-reviewed literature for determining the medical acceptability of unlabeled uses.  (*These two compendia currently are being merged as the result of an alliance between the American Medical Association and the United States Pharmacopeia.)

Dissemination of Information about Unlabeled Uses of Drugs and Devices by Manufacturers

(2) APA strongly supports the need for physicians to have access to accurate and unbiased information about unlabeled uses of drugs and devices, while ensuring that manufacturer-sponsored promotions remain under FDA regulation.

(3) APA supports the dissemination of independently derived scientific information about unlabeled uses by manufacturers to physicians, if the independent information is provided in its entirety [including comprehensive results of relevant clinical trials], is not edited or altered by the manufacturer, and is clearly distinguished from manufacturer-sponsored materials. Dissemination of information by manufacturers to physicians about unlabeled uses can be supported under the following conditions:

  (a) For Reprints of independently derived articles from reputable, peer-reviewed
        journals, the following criteria must be met:

  1. The article should be peer reviewed and published in accordance with the regular peer review procedure of the journal in which it is published;
  2. The reprint should be from a peer-reviewed journal that both has an editorial board and utilizes experts to review and objectively select, reject, or provide comments about proposed articles; such experts should have demonstrated expertise in the subject of the article under review, and be independent from the journal;
  3. The journal should be recognized to be of national scope and reputation, as defined by an advisory panel to the FDA; among its members, this advisory panel should have representatives from national psychiatric societies;
  4. The journal must be indexed in the Index Medicus of the National Library of Medicine;
  5. The journal must have and adhere to a publicly stated policy of full disclosure of any conflicts of interest or biases for all authors or contributors;
  6. When the subject of the article is an unlabeled use, or the article contains information that differs from approved labeling, the industry sponsor disseminating the reprint must disclose that the reprint includes information that has not been approved by the FDA and attach a copy of the FDA-approved professional labeling with the reprint;
  7. If financial support for the study and/or the author(s) was provided by the industry sponsor disseminating the reprint, and this is not already stated in the article, then this information should be clearly disclosed with the reprint.

  (b) For Reprints of monographs or chapters from the three compendia (AMA’s
        Drug Evaluations; United States Pharmacopeia-Drug Information, Volume I;
        and American Hospital Formulary Service-Drug Information) named in federal 
        statutes for determining the medical acceptability of unlabeled uses, the
        following criteria must be met:

  1. The monograph or chapter should be reprinted in entirety by the publisher of the compendia, and the reprints then sent to the requesting industry sponsor;
  2. The reprints of the monographs or chapters should  not be altered in any way by the industry sponsor;
  3. The industry sponsor disseminating the reprint of the monograph or chapter s should disclose that the reprint includes information that has not been approved by the FDA and should attach a copy of the FDA-approved professional labeling with the reprint.

  (c) For Complete Textbooks the following criteria must be met:

  1. The reference text should not have been written, edited, excerpted, or published specifically for, or at the request of, a drug, device, or biologic firm; when financial support is provided by a drug, device, or biologic firm, it should be disclosed clearly in the textbook;
  2. The content of the reference text should not have been edited or significantly influenced by a drug, device, or biologic firm, or agent thereof;
  3. The reference text should be generally available for sale in bookstores or other distribution channels where similar texts are normally available and should not be distributed only or primarily through drug, device, or biologic firms; 
  4. The reference text should not focus primarily on any particular drug(s), device(s), or biologic(s) of the disseminating company, nor should it have a significant focus on unapproved uses of drug(s), device(s), or biologic(s) marketed or under investigation by the firm supporting the dissemination of the text;
  5. Specific product information (other than the approved package insert) should not be physically appended to the reference text.

  (d) For Proprietary Information indicating that a drug is ineffective or unsafe when
        used for a specific unlabeled indication, manufacturers should report to the
        FDA and share with all physicians all of the proprietary information.

  (e) For Continuing Medical Education (CME) activities and information:

  1. The FDA should continue to support principles in the FDA Draft Policy Statement on Industry-Supported Scientific and Educational Activities (Fed. Reg. 1992;57:56412-56414); the FDA Draft Policy Statement acknowledges the importance of relying on professional health-care communities, rather than the FDA, to monitor independent provider activities;
  2. The FDA should continue a policy of regulatory deference for industry-supported CME activities conducted by organizations accredited by the Accreditation Council for Continuing Medical Education (ACCME), state medical societies, and specialty societies such as  the American Psychiatric Association (APA), that follow the Essentials and Standards of the ACCME and that may be certified for AMA PRA credit under the auspices of the American Medical Association Physician’s Recognition Award program.

(4) APA strongly supports the responsibility of physicians  to interpret and put into context evidence  received from all sources [including pharmaceutical manufacturers], before making clinical decisions (i.e.., prescribing a drug for an unlabeled use).

Improving the Supplemental New Drug Application (SNDA) Process

(5) APA strongly supports the addition to FDA-approved labeling those uses of drugs for which safety and efficacy have been demonstrated.

(6) APA strongly encourages the US Congress, the FDA, pharmaceutical manufacturers, the United States Pharmacopeia, patient organizations, APA and other medical specialty societies to work together to ensure that Supplemental New Drug Applications (SNDAs) for new indications (efficacy supplements), including those for uses in populations with mental disorders , are submitted and acted upon in a timely manner.  Specific recommendations include:

  (a) User fee legislation should be re-authorized to ensure that the FDA has the
        necessary resources to act on all efficacy supplements within six months of
        submission;

  (b) The SNDA process should be streamlined as much as possible without
         compromising the requirements for substantial evidence of efficacy and safety;
 
  (c) Legislation should be enacted that provides extensions of marketing exclusivity
        for a product to manufacturers who conduct supplemental research [i.e., Phase
        IV studies]  and submit efficacy supplements gaining FDA approval for
        additional indications; the legislation should place a limit on total length of
        extended marketing exclusivity;

  (d) For drugs no longer under patent and for which generic versions are
        available, the FDA, other governmental agencies (e.g., the National Institutes of
        Health), the pharmaceutical industry, the United States Pharmacopeia, patient
        organizations, the APA and other medical specialty societies should discuss
        and mutually agree on alternative mechanisms to ensure that efficacy
        supplements based on relevant research findings will be submitted to and
        acted upon by the FDA in a timely manner.

Encouraging Clinical Research in Child and Adolescent Psychiatry 

(7) APA urges pharmaceutical manufacturers and the FDA to work with the American Psychiatric Association, the American Academy of Child and Adolescent Psychiatry, and the American College of Neuropsychopharmacology  and other experts in pediatric medicine to identify those investigational drugs that should have pediatric indications and set up a mechanism to ensure that necessary pediatric clinical studies are completed prior to submission of NDAs for approval of these drug products.

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