FDA Web Site Provides Treasure Trove of Information

If you are seeking information about adequate warning labels, go to the Food and Drug Administration's (FDA) Web site (www.fda.gov) and type in “adequate warning labels.” Information will appear in milliseconds, covering everything from correspondence with manufacturers to FDA Public Health Advisories and sections from the Federal Register.

Among the myriad of information are letters to manufacturers explaining why the agency approved or disapproved the manufacturer's labeling for certain uses. For example, a November 2001 letter to Bristol-Myers Squibb concluded that the package inserts presented adequate information regarding the safe and effective use of products containing VIDEX.

There is a link to a document explaining the FDA's medical gas requirements, called Fresh Air '2000.' The program provides the FDA's interpretation of how the minimum current good manufacturing practice regulations apply to the manufacturing, filling, transfilling, cascading, etc. of medical gases, both compressed and cryogenic. (Medical gases are prescription drugs that must be dispensed by prescription only. Each firm has a responsibility to determine if its consignee, not the patient, is authorized to purchase the drug gas, and if required, is registered with the FDA and properly licensed with the state, where required, prior to selling them medical gas.)

There is the transcript of a presentation by the Consumer Healthcare Products Association on the use of dietary supplements by pregnant and lactating women; the agenda and minutes of an open session of the Drug Abuse Advisory Committee, December 1996; copies of the Center for Drug Evaluation and Research (CDER) newsletter. A July 2002 issue of “News Along the Pike” covered topics such as the CDER's aim to improve drug manufacturing and build consensus; the formation of an advisory group for process analytical technologies; the focus on patient information dispensed with prescription medicines; and guidance on pharmacy compounding: following the Supreme Court ruling on speech restrictions.

You can read the CDER Office of Drug Safety Annual Report for 2001. The report describes the goals and safety review process for that fiscal year. The Divisions of Drug Risk Evaluation's 20 safety evaluators performed hands-on review of adverse drug event reports reviewed by the FDA throughout the year. This was carried out through daily review of Adverse Event Reporting System reports that are triaged to each Safety Evaluator's electronic inbox. These reports include 15-day expedited reports, direct serious reports, and reports of designated medical events. The latter are serious events targeted by the agency that are often drug-related (eg, liver failure, bone marrow failure, Stevens-Johnson syndrome, etc). Individual reports may trigger further evaluation of similar reports in the database and development of a case series. A case series could signal important safety concerns prompting regulatory actions both in the United States and abroad.

A report titled “The Evaluation of Written Prescription Information Provided in Community Pharmacies, 2001″ describes the methods and findings of a national study to assess the quality of written prescription information provided voluntarily to persons receiving new prescription medicines in community pharmacies. The study was contracted by the U.S. Department of Health and Human Services and the FDA and conducted in collaboration with the National Association of Boards of Pharmacy and a national panel of experts in pharmacy practice, pharmacotherapy, drug information, and health communications.

You can access the PDF version of the CDER 2000 Report to the Nation on drugs and a transcripts of public meetings sponsored by the FDA such as a 1995 public hearing on Pharmaceutical Marketing and Information Exchange in Managed Care Environments and a meeting in 2000 on the Current Status of Useful Written Prescription Drug Information for Patients.

There is a wealth of information on warning labels from many perspectives ' and a litigator may consider it a treasure trove!

If you are seeking information about adequate warning labels, go to the Food and Drug Administration's (FDA) Web site (www.fda.gov) and type in “adequate warning labels.” Information will appear in milliseconds, covering everything from correspondence with manufacturers to FDA Public Health Advisories and sections from the Federal Register.

Among the myriad of information are letters to manufacturers explaining why the agency approved or disapproved the manufacturer's labeling for certain uses. For example, a November 2001 letter to Bristol-Myers Squibb concluded that the package inserts presented adequate information regarding the safe and effective use of products containing VIDEX.

There is a link to a document explaining the FDA's medical gas requirements, called Fresh Air '2000.' The program provides the FDA's interpretation of how the minimum current good manufacturing practice regulations apply to the manufacturing, filling, transfilling, cascading, etc. of medical gases, both compressed and cryogenic. (Medical gases are prescription drugs that must be dispensed by prescription only. Each firm has a responsibility to determine if its consignee, not the patient, is authorized to purchase the drug gas, and if required, is registered with the FDA and properly licensed with the state, where required, prior to selling them medical gas.)

There is the transcript of a presentation by the Consumer Healthcare Products Association on the use of dietary supplements by pregnant and lactating women; the agenda and minutes of an open session of the Drug Abuse Advisory Committee, December 1996; copies of the Center for Drug Evaluation and Research (CDER) newsletter. A July 2002 issue of “News Along the Pike” covered topics such as the CDER's aim to improve drug manufacturing and build consensus; the formation of an advisory group for process analytical technologies; the focus on patient information dispensed with prescription medicines; and guidance on pharmacy compounding: following the Supreme Court ruling on speech restrictions.

You can read the CDER Office of Drug Safety Annual Report for 2001. The report describes the goals and safety review process for that fiscal year. The Divisions of Drug Risk Evaluation's 20 safety evaluators performed hands-on review of adverse drug event reports reviewed by the FDA throughout the year. This was carried out through daily review of Adverse Event Reporting System reports that are triaged to each Safety Evaluator's electronic inbox. These reports include 15-day expedited reports, direct serious reports, and reports of designated medical events. The latter are serious events targeted by the agency that are often drug-related (eg, liver failure, bone marrow failure, Stevens-Johnson syndrome, etc). Individual reports may trigger further evaluation of similar reports in the database and development of a case series. A case series could signal important safety concerns prompting regulatory actions both in the United States and abroad.

A report titled “The Evaluation of Written Prescription Information Provided in Community Pharmacies, 2001″ describes the methods and findings of a national study to assess the quality of written prescription information provided voluntarily to persons receiving new prescription medicines in community pharmacies. The study was contracted by the U.S. Department of Health and Human Services and the FDA and conducted in collaboration with the National Association of Boards of Pharmacy and a national panel of experts in pharmacy practice, pharmacotherapy, drug information, and health communications.

You can access the PDF version of the CDER 2000 Report to the Nation on drugs and a transcripts of public meetings sponsored by the FDA such as a 1995 public hearing on Pharmaceutical Marketing and Information Exchange in Managed Care Environments and a meeting in 2000 on the Current Status of Useful Written Prescription Drug Information for Patients.

There is a wealth of information on warning labels from many perspectives ' and a litigator may consider it a treasure trove!