News from the FDA

In accordance with the Clean Air Act, the FDA is proposing to amend its regulation on the use of ozone-depleting substances in self-pressurized containers to remove the essential-use designations for albuterol used in oral pressurized metered-dose inhalers (MDIs). Two albuterol MDIs that do not use an ozone-depleting substances are currently marketed, and the FDA has tentatively determined that these two MDIs will be satisfactory alternatives to albuterol MDIs containing such substances. If the essential-use designation for albuterol MDIs is removed, albuterol MDIs containing ozone-depleting substances could not be marketed after a suitable transition period. Those wishing to submit comments on the proposed change to the regulation have until Aug. 16. For further information, go to: http://%20a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/04-13507.htm.

FDA Clears Medicinal Leeches for Marketing

For the first time, the commercial marketing of leeches for medicinal purposes has been cleared. Leeches have been shown to help heal skin grafts by removing blood pooled under the graft, and restoring blood circulation in blocked veins by removing pooled blood. Ricarimpex SAS, a French firm, is the first company to request and receive FDA clearance to market leeches as medical devices. The firm has been breeding leeches for 150 years. They are handled in a certified facility that tracks each lot.

The FDA determined that leeches are medical devices because they meet the definition of a medical device under the Food Drug and Cosmetic Act as an article intended to diagnose, cure, treat, prevent, or mitigate a disease or condition, or to affect a function or structure of the body, that does not achieve its primary effect through a chemical action, and is not metabolized.

Effective Date of Requirement for Premarket Approval for Three Class III Devices

As of June 23, the FDA is requiring the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for indwelling blood oxyhemoglobin concentration analyzers, cardiopulmonary bypass pulsatile flow generators, and the ocular plethysmograph. Under the final rule, a PMA or a notice of completion of a PDP is required to be filed on or before Sept. 21, 2004, for any of these products that were in commercial distribution before May 28, 1976, or that the FDA finds to be substantially equivalent to such a device on or before Sept. 21, 2004. If a PMA or notice of completion of a PDP is not filed in time and no investigational device exemption is in effect for the device, it will be deemed to be adulterated and subject to seizure and condemnation if its distribution continues. For more information, go to: http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/04-14126.htm..

FDA Chief Counsel Assailed for Aiding Manufacturers over Consumers

U.S. Representative Maurice Hinchey (NY-22) held a press conference July 13 to denounce recent actions taken by Daniel Troy, Chief Counsel of the Food and Drug Administration. Hinchey charged that Troy's office has repeatedly interceded in civil suits on behalf of drug and medical device manufacturers that have been accused of harming patients who had used their products, that Troy worked in cooperation with the manufacturers in taking these actions and that he ignored serious conflicts of interest in doing so. In particular, Hinchey noted that Troy, in his position as FDA Chief Counsel, advocated for Pfizer in a recent civil action even though previous to accepting his public service position, he had once earned $360,000 for legal services on Pfizer's behalf. “The mission of the Food and Drug Administration is to ensure that the public is protected from unsafe food, drugs and other medical products,” said Hinchey in a press release. “Daniel Troy is instead making it the agency's mission to protect the drug companies from being held accountable when their products do serious harm.”

In response, that same day, Dr. Lester M. Crawford, acting FDA commissioner, issued his own press release, stating, “Daniel E. Troy is a dedicated and talented public servant who has provided excellent legal advice to FDA since his appointment in August 2001. He fully complied with the ethical requirement to recuse himself from any matter involving a past client for a year after beginning work in the public sector. FDA has accurately reported the scope and nature of Dan's private sector work. Any allegation that he has not conducted himself in compliance with applicable legal and ethical rules is simply false. Dan has my utmost confidence, as well as my heartfelt gratitude for his steadfast leadership and wise counsel during this important period in FDA's history.”

Annual Guidance Agenda

The FDA is publishing its annual guidance document agenda. It lists possible topics for future guidance document development or revision during the next year, and asks for public comment on additional ideas for new guidance documents or revisions of existing ones. The topics the agency proposes to study may be obtained at: http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/04-15660.htm

FDA Will Not Interfere with Sales of Authorized Generics During Exclusivity Periods

The FDA issued responses to three Citizen Petitions last month, the cumulative effects of which will promote earlier access to lower-priced prescription drugs. In one action, the FDA denied petitions submitted by Mylan Pharmaceuticals Inc. and Teva Pharmaceuticals USA Inc. seeking to prohibit the marketing and distribution of reduced-price “authorized generic” versions of brand-name products during 180-day exclusivity periods. The agency also denied a petition submitted by Pfizer Inc., seeking to prevent generic applicants' waiver of 180-day exclusivity. In announcing these actions, the Agency stated that allowing eligible generic applicants to waive the exclusivity promotes competition by enabling other generic applicants to market their products sooner, and the agency could see “no reason to interfere with the marketing of authorized generics and waiving 180-day exclusivity, two long-standing, pro-competitive business practices.”

Proposed Change For Albuterol Oral Pressurized Metered-Dose Inhalers

In accordance with the Clean Air Act, the FDA is proposing to amend its regulation on the use of ozone-depleting substances in self-pressurized containers to remove the essential-use designations for albuterol used in oral pressurized metered-dose inhalers (MDIs). Two albuterol MDIs that do not use an ozone-depleting substances are currently marketed, and the FDA has tentatively determined that these two MDIs will be satisfactory alternatives to albuterol MDIs containing such substances. If the essential-use designation for albuterol MDIs is removed, albuterol MDIs containing ozone-depleting substances could not be marketed after a suitable transition period. Those wishing to submit comments on the proposed change to the regulation have until Aug. 16. For further information, go to: http://%20a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/04-13507.htm.

FDA Clears Medicinal Leeches for Marketing

For the first time, the commercial marketing of leeches for medicinal purposes has been cleared. Leeches have been shown to help heal skin grafts by removing blood pooled under the graft, and restoring blood circulation in blocked veins by removing pooled blood. Ricarimpex SAS, a French firm, is the first company to request and receive FDA clearance to market leeches as medical devices. The firm has been breeding leeches for 150 years. They are handled in a certified facility that tracks each lot.

The FDA determined that leeches are medical devices because they meet the definition of a medical device under the Food Drug and Cosmetic Act as an article intended to diagnose, cure, treat, prevent, or mitigate a disease or condition, or to affect a function or structure of the body, that does not achieve its primary effect through a chemical action, and is not metabolized.

Effective Date of Requirement for Premarket Approval for Three Class III Devices

As of June 23, the FDA is requiring the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for indwelling blood oxyhemoglobin concentration analyzers, cardiopulmonary bypass pulsatile flow generators, and the ocular plethysmograph. Under the final rule, a PMA or a notice of completion of a PDP is required to be filed on or before Sept. 21, 2004, for any of these products that were in commercial distribution before May 28, 1976, or that the FDA finds to be substantially equivalent to such a device on or before Sept. 21, 2004. If a PMA or notice of completion of a PDP is not filed in time and no investigational device exemption is in effect for the device, it will be deemed to be adulterated and subject to seizure and condemnation if its distribution continues. For more information, go to: http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/04-14126.htm..

FDA Chief Counsel Assailed for Aiding Manufacturers over Consumers

U.S. Representative Maurice Hinchey (NY-22) held a press conference July 13 to denounce recent actions taken by Daniel Troy, Chief Counsel of the Food and Drug Administration. Hinchey charged that Troy's office has repeatedly interceded in civil suits on behalf of drug and medical device manufacturers that have been accused of harming patients who had used their products, that Troy worked in cooperation with the manufacturers in taking these actions and that he ignored serious conflicts of interest in doing so. In particular, Hinchey noted that Troy, in his position as FDA Chief Counsel, advocated for Pfizer in a recent civil action even though previous to accepting his public service position, he had once earned $360,000 for legal services on Pfizer's behalf. “The mission of the Food and Drug Administration is to ensure that the public is protected from unsafe food, drugs and other medical products,” said Hinchey in a press release. “Daniel Troy is instead making it the agency's mission to protect the drug companies from being held accountable when their products do serious harm.”

In response, that same day, Dr. Lester M. Crawford, acting FDA commissioner, issued his own press release, stating, “Daniel E. Troy is a dedicated and talented public servant who has provided excellent legal advice to FDA since his appointment in August 2001. He fully complied with the ethical requirement to recuse himself from any matter involving a past client for a year after beginning work in the public sector. FDA has accurately reported the scope and nature of Dan's private sector work. Any allegation that he has not conducted himself in compliance with applicable legal and ethical rules is simply false. Dan has my utmost confidence, as well as my heartfelt gratitude for his steadfast leadership and wise counsel during this important period in FDA's history.”

Annual Guidance Agenda

The FDA is publishing its annual guidance document agenda. It lists possible topics for future guidance document development or revision during the next year, and asks for public comment on additional ideas for new guidance documents or revisions of existing ones. The topics the agency proposes to study may be obtained at: http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/04-15660.htm