News from the FDA

A final rule issued by the FDA will require certain human drug and biological product to bear bar codes on their labels. The bar code for human drug products and biological products (other than blood, blood components, and devices regulated by the Center for Biologics Evaluation and Research) must contain the National Drug Code (NDC) number in a linear bar code. The rule is meant to help reduce the number of medication errors in hospitals and other health care settings by allowing health care professionals to use bar code scanning equipment to verify that the right drug in the right dose and right route of administration is being given to the right patient at the right time. The rule also requires the use of machine-readable information on blood and blood component container labels to help reduce medication errors. Drug products that receive approval on or after April 26 — the rule's effective date — must comply with the bar code requirement within 60 days of the drug's approval date. Drug products that received approval before the final rule's effective date must comply with the bar code requirement within 2 years after the final rule's effective date.

Application of 30-Month Stays

In response to the passage of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 signed Dec. 8, 2003, the FDA is revoking certain sections of its regulation concerning 30-month stays of approval for abbreviated new drug applications (ANDAs) and certain new drug applications (NDAs) that contain a certification that a patent claiming the drug is invalid or will not be infringed. This action is being taken because Title XI, Access to Affordable Pharmaceuticals, contains provisions that supersede sections of the FDA regulation. Thus, 21 CFR 314.52(a)(3) and 21 CFR 314.95(a)(3) have been revoked. For further information, go to: http://a257.g.aka maitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2004/04-5407.htm.

Modification of the List of Recognized Standards

The FDA has published a document called “Modifications of the List of Recognized Standards, Recognition List Number: 009″ (Recognition List Number: 009), to assist manufacturers who elect to declare conformity with consensus standards to meet certain premarket review requirements for medical devices. At the following Web site — http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2004/E4-479.htm — the FDA describes modifications that involve: 1) the withdrawal of standards and their replacement by others; 2) the correction of errors made by the FDA in listing previously recognized standards; 3) the changes to the supplementary information sheets of recognized standards that describe revisions to the applicability of the standards; and 4) the initial addition of standards not previously recognized by the FDA.

Animal Drug User Fee Waivers Explained

The FDA last month issued a guidance for industry, “Animal Drug User Fees and Fee Waivers and Reductions,” which discusses the fee waiver provisions of the Animal Drug User Fee Act of 2003 (ADUFA). The guidance document, which is immediately in effect, can be accessed at: www.fda.gov/dockets/ecomments.

HHS Takes Steps to Fight Counterfeit Drug Threats

Health and Human Services Secretary Tommy G. Thompson released a final report on Feb. 18 highlighting the specific steps the agency is taking to keep the U.S. drug supply secure against increasingly sophisticated criminal efforts to introduce counterfeit drugs. The report describes specific steps that can be taken now and in the future to protect consumers from counterfeit drugs and to secure the U.S. drug distribution system. These measures include, among other things, a call for implementation of new technologies to prevent tampering, adoption of track-and-trace technology by 2007 and increased criminal penalties for convicted counterfeiters. The FDA Counterfeit Drug Task Force Final Report is available at www. fda.gov/oc/initiatives/counterfeit/.

Antidepressant/Suicide Link Prompts Changes to Warning Labels

The FDA has asked the makers of antidepressant drugs to place warnings on the drugs' labels indicating that patients taking antidepressant drugs may become suicidal, especially in the first weeks of treatment.

The move came after the FDA's Psychopharmacologic Drugs and Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committees, which met on Feb. 2, advised the FDA that the labeling should draw more attention to the need to monitor patients being treated with certain antidepressants.

Draft Guidance: External Penile Rigidity Devices http://a257.g.aka maitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2004/04-5979.htm.

A draft guidance describing a means by which external penile rigidity devices may comply with the requirement of special controls for class II devices has been issued but is not yet in effect. The proposed rule also announces the FDA's intent to exempt external penile rigidity devices from pre-market notification requirements. Written or electronic comments on this draft guidance will be accepted until June 15. For further information, see: http://a257.g.aka maitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2004/04-5979.htm.

Marketing Unapproved Drugs: Comment Period Reopened

The comment period on the draft guidance for industry titled “Marketing Unapproved Drugs; Compliance Policy Guide” has reopened until April 27.The FDA announced the availability of this draft guidance in the Federal Register of Oct. 23, 2003 (68 FR 60702). The initial comment period closed Dec. 22, 2003.

Crackdown on Sales of Andro

The FDA sent letters last month to 23 companies that manufacture and distribute andro products, telling them they will have to cease production unless they can prove their products are safe. Although andro is not a steroid and is marketed as a dietary supplement, the FDA says the health risks are the same. Unlike drugs, supplements do not have to be proven safe before going on the market, but federal authorities can act to take them off the shelves if the product's safety is called into question. The first time U.S. officials took such action against a nutritional supplement was when the FDA recently blocked the sale of products containing ephedra.

Delay of Effective Date: PDMA and Prescription Drug Amendments of 1992

Because the FDA is working with stakeholders through its counterfeit drug initiative to encourage widespread, voluntary adoption of track-and-trace technologies that will generate a de facto electronic pedigree, including prior transaction history back to the original manufacturer, as a routine course of business, the agency is delaying the effective date of Sections 203.3(u) and 203.50 (21 CFR 203.3(u) until Dec. 1, 2007. The delay will allow stakeholders a chance to continue to move toward the goal of universal use of track-and-trace technology, which, if widely adopted, will help fulfill the pedigree requirements of the Prescription Drug Marketing Act of 1987 (PDMA) and obviate or resolve many of the concerns that have been raised with respect to the final rule by ensuring that an electronic pedigree travels with a drug product at all times.

Final Rule Issued on Bar Code Label Requirements

A final rule issued by the FDA will require certain human drug and biological product to bear bar codes on their labels. The bar code for human drug products and biological products (other than blood, blood components, and devices regulated by the Center for Biologics Evaluation and Research) must contain the National Drug Code (NDC) number in a linear bar code. The rule is meant to help reduce the number of medication errors in hospitals and other health care settings by allowing health care professionals to use bar code scanning equipment to verify that the right drug in the right dose and right route of administration is being given to the right patient at the right time. The rule also requires the use of machine-readable information on blood and blood component container labels to help reduce medication errors. Drug products that receive approval on or after April 26 — the rule's effective date — must comply with the bar code requirement within 60 days of the drug's approval date. Drug products that received approval before the final rule's effective date must comply with the bar code requirement within 2 years after the final rule's effective date.

Application of 30-Month Stays

In response to the passage of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 signed Dec. 8, 2003, the FDA is revoking certain sections of its regulation concerning 30-month stays of approval for abbreviated new drug applications (ANDAs) and certain new drug applications (NDAs) that contain a certification that a patent claiming the drug is invalid or will not be infringed. This action is being taken because Title XI, Access to Affordable Pharmaceuticals, contains provisions that supersede sections of the FDA regulation. Thus, 21 CFR 314.52(a)(3) and 21 CFR 314.95(a)(3) have been revoked. For further information, go to: http://a257.g.aka maitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2004/04-5407.htm.

Modification of the List of Recognized Standards

The FDA has published a document called “Modifications of the List of Recognized Standards, Recognition List Number: 009″ (Recognition List Number: 009), to assist manufacturers who elect to declare conformity with consensus standards to meet certain premarket review requirements for medical devices. At the following Web site — http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2004/E4-479.htm — the FDA describes modifications that involve: 1) the withdrawal of standards and their replacement by others; 2) the correction of errors made by the FDA in listing previously recognized standards; 3) the changes to the supplementary information sheets of recognized standards that describe revisions to the applicability of the standards; and 4) the initial addition of standards not previously recognized by the FDA.

Animal Drug User Fee Waivers Explained

The FDA last month issued a guidance for industry, “Animal Drug User Fees and Fee Waivers and Reductions,” which discusses the fee waiver provisions of the Animal Drug User Fee Act of 2003 (ADUFA). The guidance document, which is immediately in effect, can be accessed at: www.fda.gov/dockets/ecomments.

HHS Takes Steps to Fight Counterfeit Drug Threats

Health and Human Services Secretary Tommy G. Thompson released a final report on Feb. 18 highlighting the specific steps the agency is taking to keep the U.S. drug supply secure against increasingly sophisticated criminal efforts to introduce counterfeit drugs. The report describes specific steps that can be taken now and in the future to protect consumers from counterfeit drugs and to secure the U.S. drug distribution system. These measures include, among other things, a call for implementation of new technologies to prevent tampering, adoption of track-and-trace technology by 2007 and increased criminal penalties for convicted counterfeiters. The FDA Counterfeit Drug Task Force Final Report is available at www. fda.gov/oc/initiatives/counterfeit/.

Antidepressant/Suicide Link Prompts Changes to Warning Labels

The FDA has asked the makers of antidepressant drugs to place warnings on the drugs' labels indicating that patients taking antidepressant drugs may become suicidal, especially in the first weeks of treatment.

The move came after the FDA's Psychopharmacologic Drugs and Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committees, which met on Feb. 2, advised the FDA that the labeling should draw more attention to the need to monitor patients being treated with certain antidepressants.

Draft Guidance: External Penile Rigidity Devices http://a257.g.aka maitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2004/04-5979.htm.

A draft guidance describing a means by which external penile rigidity devices may comply with the requirement of special controls for class II devices has been issued but is not yet in effect. The proposed rule also announces the FDA's intent to exempt external penile rigidity devices from pre-market notification requirements. Written or electronic comments on this draft guidance will be accepted until June 15. For further information, see: http://a257.g.aka maitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2004/04-5979.htm.

Marketing Unapproved Drugs: Comment Period Reopened

The comment period on the draft guidance for industry titled “Marketing Unapproved Drugs; Compliance Policy Guide” has reopened until April 27.The FDA announced the availability of this draft guidance in the Federal Register of Oct. 23, 2003 (68 FR 60702). The initial comment period closed Dec. 22, 2003.

Crackdown on Sales of Andro

The FDA sent letters last month to 23 companies that manufacture and distribute andro products, telling them they will have to cease production unless they can prove their products are safe. Although andro is not a steroid and is marketed as a dietary supplement, the FDA says the health risks are the same. Unlike drugs, supplements do not have to be proven safe before going on the market, but federal authorities can act to take them off the shelves if the product's safety is called into question. The first time U.S. officials took such action against a nutritional supplement was when the FDA recently blocked the sale of products containing ephedra.