News from the FDA

Three draft guidances for industry, titled “Premarketing Risk Assessment,” “Development and Use of Risk Minimization Action Plans,” and “Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment,” all dated May 2004, have been issued. These draft guidances address safety issues that can arise throughout a product's entire life cycle, including its development, the review and approval process, and after it is available on the market. Written and electronic comments on the draft guidances will be accepted through July 6. The FDA says it is specifically interested in comments on how to best characterize the types and levels of risk that might suggest the need for a risk management plan. To obtain these documents, go to http:// www.fda.gov/cder/guidance/index.htm.

Critical Path Initiative: Comments Sought

On March 16, the FDA released a report, “Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products,” available at http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.pdf. The report notes the recent slowdown in new medical products submitted for approval to the FDA, and describes ways in which the product development process — the “critical path” — could be modernized to make product development more predictable and less costly. In its effort to speed the process, the FDA is seeking input on identification of the most pressing scientific and/or technical hurdles causing major delays and other problems in the drug, device, and/or biologic development process, as well as proposed approaches to their solution. Comments may be submitted until July 30 to: 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/ecom ments. For further details concerning the specific information the FDA is seeking in this request for comments, go to: http://a257.g.akamaitech.net/7/ 257/2422/14mar20010800/edocket.access.gpo.gov/2004/04-9147.htm

Pre-Approval Information: Veterinary Antimicrobial Medical Products

The International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) has developed a guidance for veterinary use titled “Pre-Approval Information for Registration of New Veterinary Medicinal Products for Food-Producing Animals With Respect to Antimicrobial Resistance.” This VICH guidance document is an initial step in developing harmonized technical guidance in the European Union, Japan, and the United States for approval of therapeutic antimicrobial veterinary medicinal products intended for use in food-producing animals. The guidance outlines the types of studies and data recommended for assessing the potential for resistance to develop in food-producing animals with the use of antimicrobial drugs. It can be obtained at: http://www.fda.gov/cvm/antimicro bial/antimicrobial.html.

Pancreatic Extract Manufacturers to Submit Marketing Applications

On April 27, the FDA notified manufacturers of pancreatic insufficiency products that these drugs must get approval by the FDA within the next 4 years in order to remain on the market. The FDA decided to require approval of new drug applications for all pancreatic extract drug products after reviewing data that showed variations in the formulation, dosage, and manufacturing processes affected the potency, in terms of both the products' activity and release rate, of the enzymes after patients take them. Only one pancreatic extract product has ever received formal FDA approval, but it is no longer marketed. The other products currently on the market continue to be available because of their established use as replacement therapies to treat serious conditions associated with pancreatic insufficiency, including chronic pancreatitis and cystic fibrosis.

Also on April 27, the FDA issued a draft guidance for industry that, when finalized, will assist manufacturers of pancreatic extract preparations in preparing and submitting applications. More information, including a list of “Questions and Answers” about the FDA's action, is available at: http://www.fda.gov/cder/drug/infopage/pancreatic_drugs/default.htm.

Pediatric Medical Device Guidance Available

The FDA has published a guidance for industry called “Premarket Assessment of Pediatric Medical Devices,” which outlines the safety and effectiveness information needed to support marketing of pediatric devices and describes measures to be taken to protect children involved in clinical trials of such products. To access the guidance, go to: http://www.accessda ta.fda.gov/scripts/oc/ohrms/dailylist.cfm?yr=2004&mn=5&dy=14 .

Relief of Travelers' Diarrhea Claims Allowed

In accordance with a final rule amending the final monograph for over-the-counter antidiarrheal products containing bismuth subsalicylate, such products may now claim that they relieve travelers' diarrhea. For more information, see: http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2004/04-10750.htm.

Two Cancer Treatment Drugs Fail to Make the Grade

On May 3, the FDA's Oncologic Advisory Committee recommended against approval of two cancer treatment drugs: Genasense' by Genta Inc., and RSR13', developed by Allos Therapeutics. Trials for both drugs failed to show that they increased life expectancy, but the companies argued the drugs delayed the onset of symptoms. In the end, the panel found that evidence of the drugs' advantages did not outweigh the risks of side effects.

Three Guidances Promote Minimization of Risks

Three draft guidances for industry, titled “Premarketing Risk Assessment,” “Development and Use of Risk Minimization Action Plans,” and “Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment,” all dated May 2004, have been issued. These draft guidances address safety issues that can arise throughout a product's entire life cycle, including its development, the review and approval process, and after it is available on the market. Written and electronic comments on the draft guidances will be accepted through July 6. The FDA says it is specifically interested in comments on how to best characterize the types and levels of risk that might suggest the need for a risk management plan. To obtain these documents, go to http:// www.fda.gov/cder/guidance/index.htm.

Critical Path Initiative: Comments Sought

On March 16, the FDA released a report, “Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products,” available at http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.pdf. The report notes the recent slowdown in new medical products submitted for approval to the FDA, and describes ways in which the product development process — the “critical path” — could be modernized to make product development more predictable and less costly. In its effort to speed the process, the FDA is seeking input on identification of the most pressing scientific and/or technical hurdles causing major delays and other problems in the drug, device, and/or biologic development process, as well as proposed approaches to their solution. Comments may be submitted until July 30 to: 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/ecom ments. For further details concerning the specific information the FDA is seeking in this request for comments, go to: http://a257.g.akamaitech.net/7/ 257/2422/14mar20010800/edocket.access.gpo.gov/2004/04-9147.htm

Pre-Approval Information: Veterinary Antimicrobial Medical Products

The International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) has developed a guidance for veterinary use titled “Pre-Approval Information for Registration of New Veterinary Medicinal Products for Food-Producing Animals With Respect to Antimicrobial Resistance.” This VICH guidance document is an initial step in developing harmonized technical guidance in the European Union, Japan, and the United States for approval of therapeutic antimicrobial veterinary medicinal products intended for use in food-producing animals. The guidance outlines the types of studies and data recommended for assessing the potential for resistance to develop in food-producing animals with the use of antimicrobial drugs. It can be obtained at: http://www.fda.gov/cvm/antimicro bial/antimicrobial.html.

Pancreatic Extract Manufacturers to Submit Marketing Applications

On April 27, the FDA notified manufacturers of pancreatic insufficiency products that these drugs must get approval by the FDA within the next 4 years in order to remain on the market. The FDA decided to require approval of new drug applications for all pancreatic extract drug products after reviewing data that showed variations in the formulation, dosage, and manufacturing processes affected the potency, in terms of both the products' activity and release rate, of the enzymes after patients take them. Only one pancreatic extract product has ever received formal FDA approval, but it is no longer marketed. The other products currently on the market continue to be available because of their established use as replacement therapies to treat serious conditions associated with pancreatic insufficiency, including chronic pancreatitis and cystic fibrosis.

Also on April 27, the FDA issued a draft guidance for industry that, when finalized, will assist manufacturers of pancreatic extract preparations in preparing and submitting applications. More information, including a list of “Questions and Answers” about the FDA's action, is available at: http://www.fda.gov/cder/drug/infopage/pancreatic_drugs/default.htm.

Pediatric Medical Device Guidance Available

The FDA has published a guidance for industry called “Premarket Assessment of Pediatric Medical Devices,” which outlines the safety and effectiveness information needed to support marketing of pediatric devices and describes measures to be taken to protect children involved in clinical trials of such products. To access the guidance, go to: http://www.accessda ta.fda.gov/scripts/oc/ohrms/dailylist.cfm?yr=2004&mn=5&dy=14 .

Relief of Travelers' Diarrhea Claims Allowed

In accordance with a final rule amending the final monograph for over-the-counter antidiarrheal products containing bismuth subsalicylate, such products may now claim that they relieve travelers' diarrhea. For more information, see: http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2004/04-10750.htm.