CHPA contact: Phyllis Taylor

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CHPA President Linda A. Suydam, D.P.A., announced December 9, the promotion of  Lorna C. Totman, Ph.D., DABT, to senior director of Scientific Affairs and Toxicology, in the newly renamed Department of Regulatory and Scientific Affairs (see related article). Totman was awarded the new title in recognition of her many outstanding contributions to the Association over the years. As senior director, she will continue to provide her scientific expertise in a variety of areas such as drug safety, risk management, and Rx-to-OTC switch.

A pharmacologist by training, Totman joined CHPA in 1989. Prior to that, she worked for Clement Associates; the American National Red Cross Blood Research Laboratory; Woodard Research Corporation; and the SRI International Center for Occupational and Environmental Safety and Health. She serves as an assistant professorial lecturer in pharmacology at the George Washington University School of Medicine and Health Sciences and holds a doctorate in pharmacology from The George Washington University and is a diplomate of the American Board of Toxicology.

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A CHPA department by any other name. . .

Science & Technology Department is now the Department of Regulatory and Scientific Affairs

In an effort to more closely convey the Association's activities regarding scientific, regulatory, and technical issues, CHPA President Linda A. Suydam, D.P.A., has changed the name of the Science & Technology Department to the Department of Regulatory and Scientific Affairs. Please note that this change is also reflected in the title of that department's head ― R. William Soller, Ph.D., senior vice president and director, Regulatory and Scientific Affairs. 

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FDA commissioner calls for more information, tighter enforcement on foods and dietary supplements

FDA Commissioner Mark B. McClellan, announced a new plan December 18 to make more  information on foods and dietary supplements available to American consumers. According to McClellan, this new initiative has a two-fold purpose: to encourage manufacturers to make accurate, science-based claims for their products and to help eliminate false and misleading claims by taking on those marketers who make them. A descriptive summary of the Consumer Health Information for Better Nutrition initiative is available at www.fda.gov/oc/nutritioninitiative/whitepaper.html.

Specifically, the plan includes the following action items:

• The issuance of a guidance on qualified health claims for conventional foods and dietary supplements that states, among other things, that claims must meet the "weight of the scientific evidence" standard, including support by a credible body of scientific evidence. FDA will exercise enforcement discretion when such claims are the subject of a health claim petition.
  
• The strengthening of FDA's enforcement of dietary supplement rules, including seizure of dietary supplement products that make unapproved drug claims.
  
• The creation of an FDA Task Force on Consumer Health Information for Better Nutrition with the goal of developing a framework to help consumers locate credible science-based information about conventional foods and dietary supplements.

In the area of enforcement, FDA has posted a Dietary Supplement Enforcement Report to its web site. This document reviews FDA dietary supplement inspection activities, warning letters, seizures, criminal prosecutions, inter-agency enforcement measures, and international efforts. The report also reiterates FDA's intent to propose Good Manufacturing Practices for dietary supplements "soon."

FDA's notice of the guidance is published in the December 20 Federal Register. The guidance itself is available at www.fda.gov/OHRMS/DOCKETS/98fr/guidance[1].html. 

CHPA contact: Dave Spangler

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NCCAM announces plan for three new research initiatives

The National Institutes of Health's National Center for Complementary and Alternative Medicine (NCCAM) announced December 17 its plan to establish three new programs for research on complementary and alternative medicine (CAM). The first is a center for excellence that will support program project grants to elucidate the mechanisms of action of CAM modalities. The second opportunity is for developmental centers for research in which CAM and conventional institutions and investigators will partner to conduct exploratory and developmental research projects. The third initiative is for planning grants for research that will support exploratory and developmental grants for U.S. and international institutions to jointly plan studies on CAM approaches. Requests for applications for each of these programs are available at http://nccam.nih.gov.

CHPA contact: Dr. Leila Saldanha

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Unified agenda published

FDA’s semi-annual regulatory agenda was included in the December 9 Federal Register with the government’s unified agenda, which serves as a very rough tool of an agency’s plans to review, propose, or issue regulations over the next 12 months. Many of the expected dates have been revised from previous agendas.

For OTC Review-related documents, entries include the following:

Final monographs:

Antidiarrheals: April 2003
Antiperspirants: April 2003
*Cough/cold combination products: April 2003
Skin protectants: April 2003

Monograph amendments:

Antidiarrheals – travelers diarrhea proposal: April 2003
Cough/cold nasal decongestant -- phenylpropanolamine proposal: April 2003
Internal analgesics -- pediatric proposal: April 2003
Laxatives – psyllium granular dosage form proposal: October 2003
Ophthalmics – emergency first aid eyewash proposal: January 2003
Ophthalmics technical amendment: January 2003
Skin protectants – astringents: June 2003
Skin protectants – astringent proposal: June 2003
Sunscreens UVA/UVB proposal: August 2003
Vaginal contraceptives proposal: March 2003
Weight control – phenylpropanolamine proposal: April 2003

Other final rules:

Cation (Ca, Mg, K, Na) labeling: June 2003
Sodium labeling: June 2003
Salicylates – Reye Syndrome warning: April 2003

Proposed rules:

Convenience sizes – labeling format: March 2003
Sodium labeling: June 2003
Oral health care – plaque/gingivitis advance notice of proposed rulemaking: April 2003
Sunscreens and insect repellant advance notice of proposed rulemaking: February 2003

Other FDA entries:

Final action on manufacturing change supplemental NDAs: September 2003
Interim final rule on adverse event reporting toll free numbers for NDAd products: January 2003
Proposed rule on use of bovine and ovine animal derived materials in FDA-regulated products: December 2003

Finally, the Drug Enforcement Administration included an entry on a proposed rule for security requirements for handlers of pseudoephedrine, ephedrine, and phenylpropanolamine: June 2003.

*BREAKING NEWS: FDA will publish December 23, another portion of the final rule for cough-cold drug products under the ongoing OTC review. This final rule establishes the conditions for marketing nonprescription products with combinations of active ingredients that include an antihistamine, an oral antitussive, or an analgesic-antipyretic, adding those ingredients to the others allowed in previous regulations on cough-cold combinations. Combinations of an oral bronchodilator and an expectorant or an oral nasal decongestant will be addressed in a future FDA rulemaking.

The regulation will be effective 2 years after the date of its publication. The pre-publication notice is available at http://www.fda.gov/OHRMS/DOCKETS/98fr/76n-052g-nfr0004.pdf.

CHPA contacts: Dave Spangler and Dr. Lorna Totman

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FDA announces tentative schedule for advisory committee meetings

FDA published a tentative schedule of 2003 public advisory committee meetings in the December 19 Federal Register. The tentative dates for 2003 Nonprescription Drugs Advisory Committee meetings are March 6-7, June 13-14, and September 11-12. Please note that June 14 is a Saturday and this meeting date will presumably be changed by FDA. Any changes to the schedule will be posted on FDA's web site at www.fda.gov/oc/advisory/default.htm. 

CHPA contact: Dr. Lorna Totman 

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APhA to change its name to the American Pharmacists Association

Members of the American Pharmaceutical Association (APhA) recently voted to change the name of the Association to the American Pharmacists Association.  The name change will formally take effect March 29. 2003, at the association's annual meeting. According to APhA, the new name will enable the organization to become a more effective representative of America's pharmacists. 

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CHPA holiday schedule

CHPA's staff will be operating under the following holiday schedule:

December 20: (staff office party begins at noon, office closes at 2:00 p.m.)
December 23: Office closed
December 24: Office closed
December 25: Office closed
January 1: Office closed

The office will be open on all other business days.

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2003 CHPA member dues deadline reminder

CHPA MarketPlace
September 18, 2003
Hilton East Brunswick
13 Tower Center Blvd.
East Brunswick, New Jersey

Manufacturing Controls Seminar
October 9-10, 2003
Hilton Parsippany Hotel
One Hilton Court
Parsippany, New Jersey

Research & Scientific Development Conference
November 6-7, 2003
Washington, D.C., area

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