News from the FDA

FDA Commissioner Mark McClellan issued a statement following passage of the Animal Drug User Fee Act commending Congressional authorizing committees and the bill's sponsors for their bipartisan action in passing the legislation. When enacted, this bill will authorize a program of fees by the FDA relating to the review of new animal drugs. The program is similar to the program for human drugs that has been in place for over 10 years. Like the Prescription Drug User Fee Act, and the Medical Device User Fee and Modernization Act, this legislation is intended to help the FDA expedite and improve its review of applications for new animal drugs. The legislation authorizes the collections of annual user fees totaling $43 million over 5 years, beginning with $5 million in Fiscal Year 2004, to enable the FDA to hire and train additional scientific reviewers and implement enhanced processes to accelerate and improve the review of new animal drugs.

Meeting to Discuss Antidepressants and Teen Suicide

On Feb. 2, 2004, the Psychopharma-cologic Drugs Advisory Committee and the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee will conduct an open meeting to discuss reports of the occurrence of suicidal ideation and attempts in clinical trials for various antidepressant drugs in pediatric patients with major depressive disorder (MDD). The committee will consider the question of what regulatory action may be needed pertinent to the clinical use of these products in pediatric patients. The committee will also consider further research needs to address questions on this topic.

Those interested may present data, information, or views, orally or in writing, on issues pending before the committee. For further information, see: http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-27394.htm.

Warning to Importers of GSK Diskus

A warning to U.S. consumers was issued by the FDA on November 14, alerting those who might have imported GlaxoSmithKline's Ventolin Diskus, Flovent Diskus or Serevent Diskus from Canada that the Canadian government had recalled some of these products. The products were recalled November 12 because of concerns that they might malfunction and deliver too little of the drug they contain. U.S. supplies of these products were not affected by the recall.

Third Treatment for Impotence Approved

On November 21, the FDA approved a third oral medication to treat erectile dysfunction, Cialis(r) (tadalafil). The drug, manufactured by Eli Lilly and Co., was tested in randomized, placebo-controlled trials involving 4000 men with erectile dysfunction. Cialis' remains in the body for longer than previously approved drugs for this condition and was shown in trials to improve erectile function for up to 36 hours in patients taking it.

International Harmonization Guidances Available

Two guidances prepared under the auspices of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) are now available. The first is a guidance, effective November 21, titled “Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV” (the Q1F guidance). The second is a revised guidance titled “Q1A(R2) Stability Testing of New Drug Substances and Products” (the Q1A guidance). The Q1F guidance, which is an annex to the Q1A guidance, defines an approach for broader use of the Q1A guidance for territories in climatic zones III and IV. The revised Q1A guidance incorporates relevant Q1F recommendations. The documents may be obtained at

http://www.fda.gov/ohrms/dock%20ets/default.htm,

http://www.fda.gov%20/cder/guidance/index.htm,

or http:// www.fda.gov/cber/publications.htm.

Third-Party Inspection Program

A list of accredited inspectors eligible to inspect manufacturers of class II and class III devices in lieu of an FDA inspection has just published. The FDA is currently developing a guidance to help establishments determine whether they are qualified to participate in the third-party inspection program, but because all the accredited inspectors will have to complete training before conducting independent inspections under the new program, the inspectors listed will not be available to companies for several months. In the meantime, any company interested in participating in the third-party inspection program may obtain more information about it at: http://a257.g.akamaitech.%20net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/0327879.htm. The list of approved inspectors can be found at http://www.fda.gov/cdrh/%20ap-inspection/

Guidance Documents Now Available

• Premarket Approval Application Modular Review — This guidance contains information regarding the premarket approval application (PMA) modular review program and is in effect immediately. For further information, see: http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-27561.htm.
• Pharmacogenomic Data Submissions — A draft guidance is available that provides recommendations to sponsors holding investigational new drug applications (INDs), new drug applications (INDAs), and biologics license applications (BLAs) on what pharmacogenomic data to submit to the agency during the drug development process, the format of submissions, and how the data will be used in regulatory decision-making. For further information, go to: http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-27646.htm.
• IRB Review of Stand-Alone HIPAA Authorizations Under FDA Regulations — This guidance document, dated Oct. 21, 2003, provides clarification for institutional review boards (IRBs) of their responsibilities for reviewing and approving stand-alone authorizations under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule. This guidance is similar to one published by the Office of Civil Rights, Department of Health and Human Services (HHS), entitled “Privacy Guidance about Authorizations for Research and Institutional Review Boards,” which is available on the HHS Web site at: http://www.hhs.gov/ocr/hipaa.

A stand-alone HIPAA authorization is a document used to obtain permission from an individual for a covered entity to use and/or disclose the individual's identifiable health information for a research study and that is not combined with an informed consent document to participate in the research itself. This guidance is intended to encourage IRBs to permit enrollment of subjects in clinical investigations without the IRB's prior review and/or approval of stand-alone HIPAA authorizations, even under circumstances in which the IRB's written procedures require such review and/or approval.

Premarket Approval for Three Class III Preamendments Devices

The FDA wants to require filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following three class III preamendments devices: indwelling blood oxyhemoglobin concentration analyzer, cardiopulmonary bypass pulsatile flow generator, and the ocular plethysmograph. In addition, requests can now be made to the agency to change the classification of any of the devices based on new information. Submit written comments or requests for a change in classification to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. For further information, go to: http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-28741.htm.

McClellan Lauds Passage of Animal Drug User Fee Bill

FDA Commissioner Mark McClellan issued a statement following passage of the Animal Drug User Fee Act commending Congressional authorizing committees and the bill's sponsors for their bipartisan action in passing the legislation. When enacted, this bill will authorize a program of fees by the FDA relating to the review of new animal drugs. The program is similar to the program for human drugs that has been in place for over 10 years. Like the Prescription Drug User Fee Act, and the Medical Device User Fee and Modernization Act, this legislation is intended to help the FDA expedite and improve its review of applications for new animal drugs. The legislation authorizes the collections of annual user fees totaling $43 million over 5 years, beginning with $5 million in Fiscal Year 2004, to enable the FDA to hire and train additional scientific reviewers and implement enhanced processes to accelerate and improve the review of new animal drugs.

Meeting to Discuss Antidepressants and Teen Suicide

On Feb. 2, 2004, the Psychopharma-cologic Drugs Advisory Committee and the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee will conduct an open meeting to discuss reports of the occurrence of suicidal ideation and attempts in clinical trials for various antidepressant drugs in pediatric patients with major depressive disorder (MDD). The committee will consider the question of what regulatory action may be needed pertinent to the clinical use of these products in pediatric patients. The committee will also consider further research needs to address questions on this topic.

Those interested may present data, information, or views, orally or in writing, on issues pending before the committee. For further information, see: http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-27394.htm.

Warning to Importers of GSK Diskus

A warning to U.S. consumers was issued by the FDA on November 14, alerting those who might have imported GlaxoSmithKline's Ventolin Diskus, Flovent Diskus or Serevent Diskus from Canada that the Canadian government had recalled some of these products. The products were recalled November 12 because of concerns that they might malfunction and deliver too little of the drug they contain. U.S. supplies of these products were not affected by the recall.

Third Treatment for Impotence Approved

On November 21, the FDA approved a third oral medication to treat erectile dysfunction, Cialis(r) (tadalafil). The drug, manufactured by Eli Lilly and Co., was tested in randomized, placebo-controlled trials involving 4000 men with erectile dysfunction. Cialis' remains in the body for longer than previously approved drugs for this condition and was shown in trials to improve erectile function for up to 36 hours in patients taking it.

International Harmonization Guidances Available

Two guidances prepared under the auspices of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) are now available. The first is a guidance, effective November 21, titled “Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV” (the Q1F guidance). The second is a revised guidance titled “Q1A(R2) Stability Testing of New Drug Substances and Products” (the Q1A guidance). The Q1F guidance, which is an annex to the Q1A guidance, defines an approach for broader use of the Q1A guidance for territories in climatic zones III and IV. The revised Q1A guidance incorporates relevant Q1F recommendations. The documents may be obtained at

http://www.fda.gov/ohrms/dock%20ets/default.htm,

http://www.fda.gov%20/cder/guidance/index.htm,

or http:// www.fda.gov/cber/publications.htm.

Third-Party Inspection Program

A list of accredited inspectors eligible to inspect manufacturers of class II and class III devices in lieu of an FDA inspection has just published. The FDA is currently developing a guidance to help establishments determine whether they are qualified to participate in the third-party inspection program, but because all the accredited inspectors will have to complete training before conducting independent inspections under the new program, the inspectors listed will not be available to companies for several months. In the meantime, any company interested in participating in the third-party inspection program may obtain more information about it at: http://a257.g.akamaitech.%20net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/0327879.htm. The list of approved inspectors can be found at http://www.fda.gov/cdrh/%20ap-inspection/

Guidance Documents Now Available

• Premarket Approval Application Modular Review — This guidance contains information regarding the premarket approval application (PMA) modular review program and is in effect immediately. For further information, see: http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-27561.htm.
• Pharmacogenomic Data Submissions — A draft guidance is available that provides recommendations to sponsors holding investigational new drug applications (INDs), new drug applications (INDAs), and biologics license applications (BLAs) on what pharmacogenomic data to submit to the agency during the drug development process, the format of submissions, and how the data will be used in regulatory decision-making. For further information, go to: http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-27646.htm.
• IRB Review of Stand-Alone HIPAA Authorizations Under FDA Regulations — This guidance document, dated Oct. 21, 2003, provides clarification for institutional review boards (IRBs) of their responsibilities for reviewing and approving stand-alone authorizations under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule. This guidance is similar to one published by the Office of Civil Rights, Department of Health and Human Services (HHS), entitled “Privacy Guidance about Authorizations for Research and Institutional Review Boards,” which is available on the HHS Web site at: http://www.hhs.gov/ocr/hipaa.

A stand-alone HIPAA authorization is a document used to obtain permission from an individual for a covered entity to use and/or disclose the individual's identifiable health information for a research study and that is not combined with an informed consent document to participate in the research itself. This guidance is intended to encourage IRBs to permit enrollment of subjects in clinical investigations without the IRB's prior review and/or approval of stand-alone HIPAA authorizations, even under circumstances in which the IRB's written procedures require such review and/or approval.