News from the FDA

Medical Device PMA Approvals

A list of pre-market approval applications (PMAs) that have been approved by the Center for Biologics Evaluation and Research for which summaries of safety and effectiveness were placed on the Internet from Dec. 5, 2001, through Sept. 30, 2003, has been released. There were no denial actions during the period. The list can be found at www.fda.gov.

Tentative Schedule of Meetings for 2004

A tentative schedule of forthcoming meetings of the FDA's public advisory committees for 2004 has been published and is available at http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-32103.htm You may also obtain up-to-date meeting information by calling the Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area).

Draft Guidance on Drug Substance

A new draft guidance for industry titled “Drug Substance: Chemistry, Manufacturing, and Controls Information” is now available. This draft guidance provides recommendations on the chemistry, manufacturing, and controls (CMC) information for drug substances that should be submitted to support original new drug applications (NDAs), abbreviated new drug applications (ANDAs), new animal drug applications (NADAs), and abbreviated new animal drug applications (ANADAs). The draft guidance is structured to help in the preparation of applications submitted in Common Technical Document (CTD) format.

In it, recommendations are provided on the information that should be included for: 1) Nomenclature, structure, and general drug substance properties, 2) manufacture, 3) characterization, 4) control of drug substance, 5) reference standards or materials, 6) container closure systems, and 7) stability. The draft guidance, when finalized, will replace the guidance titled “Submitting Supporting Documentation in Drug Applications for the

Manufacture of Drug Substance” (February 1987). The document can be found at www. fda.gov/cder/guidance/index.htm.

Minnesota Governor Meets with FDA

Minnesota Governor Tim Pawlenty met January 15 with FDA officials to discuss his state's proposal to import drugs from Canada for state employees and to set up a Web site to allow state residents to buy reimported drugs from state-approved Canadian pharmacies. According to the St. Paul Pioneer Press (Jan. 16), Pawlenty reported after the meeting that the FDA officials he met with made no “promises, guarantees [or] threats.” The state plans to launch its Web site this month.

OTC Drug Products: Safety and Efficacy Review

The FDA has announced a call for data for certain categories of ingredients in over-the-counter drug products that are eligible for the original OTC drug review but have not been reviewed by the agency to date.

The categories of ingredients in this latest call-for-data notice are: 1) Nasal moisturizer drug products, 2) urinary analgesic/antiseptic drug products, 3) urinary acidifiers and alkalinizers, 4) aloe vera and urea, 5) wrinkle remover products, and 6) lubricants and vaginal moisturizers. The FDA will review the submitted data and information as part of its ongoing review of OTC drug products to determine whether these ingredients and products are generally recognized as safe and effective (GRAS/E) for their labeled uses. For further information, see http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-32102.htm. .

Breast Implant Maker Gets Bad News

In a somewhat surprising move, the FDA issued Inamed Corp. a “not approvable” letter on January 7. The letter concerns a pre-market approval application (PMA) for Inamed's silicone breast implant product. The letter outlines the additional information that Inamed must provide before the FDA can further review its PMA. Nick Teti, Chairman, Chief Executive Officer and President of Inamed, was quoted on the company's Web site, saying, “The FDA letter that we received provides directions for us to follow, and we intend to work cooperatively with the agency to place the PMA in approvable form.”

FDA Sees Rebound in Approval of Innovative Drugs in 2003

After review of 2003's statistics, the FDA announced in a January 15 news release that overall drugs and biologics approvals for calendar year had increased, and the time it took the agency to review and approve most applications had decreased. The agency's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) approved 466 new and generic drugs and biological products. Prospectively, through a series of new initiatives now being implemented, the agency hopes to reach its goal of reducing the average total FDA time for review before marketing approval by 30 days for priority applications, and 2 months for standard applications for the first half of the approval cohort for applications submitted in FY 2005-2007 and beyond. This correlates to at least a 10% reduction.

Importers of Canadian Drugs Receive Warning Letters

The FDA issued warning letters January 22 to Expedite-Rx, a pharmacy benefits manager; SPC Global Technologies Ltd., an insurance claims processor, and Employer Health Options Inc., an insurance company, all of Temple, TX. The letters notified the companies that the FDA considers their drug import program to be illegal and a risk to public health. The letter accuses the firms of facilitating illegal imports of prescription drugs from Canada, and misleading the public about the drugs' safety, and states that these products could present significant risk to the program's members, who include employees and retirees of the City of Montgomery, AL.

The FDA noted in its announcement concerning the warning letters that it had found increasing evidence that many drugs obtained from foreign sources that purport to be U.S.-approved or Canadian products are, in fact, products of unknown quality that were manufactured and packaged in other parts of the world.

Medical Device PMA Approvals

A list of pre-market approval applications (PMAs) that have been approved by the Center for Biologics Evaluation and Research for which summaries of safety and effectiveness were placed on the Internet from Dec. 5, 2001, through Sept. 30, 2003, has been released. There were no denial actions during the period. The list can be found at www.fda.gov.

Tentative Schedule of Meetings for 2004

A tentative schedule of forthcoming meetings of the FDA's public advisory committees for 2004 has been published and is available at http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-32103.htm You may also obtain up-to-date meeting information by calling the Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area).

Draft Guidance on Drug Substance

A new draft guidance for industry titled “Drug Substance: Chemistry, Manufacturing, and Controls Information” is now available. This draft guidance provides recommendations on the chemistry, manufacturing, and controls (CMC) information for drug substances that should be submitted to support original new drug applications (NDAs), abbreviated new drug applications (ANDAs), new animal drug applications (NADAs), and abbreviated new animal drug applications (ANADAs). The draft guidance is structured to help in the preparation of applications submitted in Common Technical Document (CTD) format.

In it, recommendations are provided on the information that should be included for: 1) Nomenclature, structure, and general drug substance properties, 2) manufacture, 3) characterization, 4) control of drug substance, 5) reference standards or materials, 6) container closure systems, and 7) stability. The draft guidance, when finalized, will replace the guidance titled “Submitting Supporting Documentation in Drug Applications for the

Manufacture of Drug Substance” (February 1987). The document can be found at www. fda.gov/cder/guidance/index.htm.

Minnesota Governor Meets with FDA

Minnesota Governor Tim Pawlenty met January 15 with FDA officials to discuss his state's proposal to import drugs from Canada for state employees and to set up a Web site to allow state residents to buy reimported drugs from state-approved Canadian pharmacies. According to the St. Paul Pioneer Press (Jan. 16), Pawlenty reported after the meeting that the FDA officials he met with made no “promises, guarantees [or] threats.” The state plans to launch its Web site this month.

OTC Drug Products: Safety and Efficacy Review

The FDA has announced a call for data for certain categories of ingredients in over-the-counter drug products that are eligible for the original OTC drug review but have not been reviewed by the agency to date.

The categories of ingredients in this latest call-for-data notice are: 1) Nasal moisturizer drug products, 2) urinary analgesic/antiseptic drug products, 3) urinary acidifiers and alkalinizers, 4) aloe vera and urea, 5) wrinkle remover products, and 6) lubricants and vaginal moisturizers. The FDA will review the submitted data and information as part of its ongoing review of OTC drug products to determine whether these ingredients and products are generally recognized as safe and effective (GRAS/E) for their labeled uses. For further information, see http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-32102.htm. .

Breast Implant Maker Gets Bad News

In a somewhat surprising move, the FDA issued Inamed Corp. a “not approvable” letter on January 7. The letter concerns a pre-market approval application (PMA) for Inamed's silicone breast implant product. The letter outlines the additional information that Inamed must provide before the FDA can further review its PMA. Nick Teti, Chairman, Chief Executive Officer and President of Inamed, was quoted on the company's Web site, saying, “The FDA letter that we received provides directions for us to follow, and we intend to work cooperatively with the agency to place the PMA in approvable form.”

FDA Sees Rebound in Approval of Innovative Drugs in 2003

After review of 2003's statistics, the FDA announced in a January 15 news release that overall drugs and biologics approvals for calendar year had increased, and the time it took the agency to review and approve most applications had decreased. The agency's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) approved 466 new and generic drugs and biological products. Prospectively, through a series of new initiatives now being implemented, the agency hopes to reach its goal of reducing the average total FDA time for review before marketing approval by 30 days for priority applications, and 2 months for standard applications for the first half of the approval cohort for applications submitted in FY 2005-2007 and beyond. This correlates to at least a 10% reduction.