|
||
|
August 2, 2002 |
No. 16-02 |
|
|||||
|
|||||
|
|||||
|
|
||||
|
|||||
|
CONTENTS Labels, not bar codes, tell consumers how to use OTCs CHPA and CTFA seek more time to change sunscreen labels CHPA to examine expanding OTC access through education CHPA pushes for a dietary supplement ingredient safety review Congressional committees approve FDA funding for FY 2003 Senate fails to pass Medicare drug benefit legislation FDA announces PDUFA rates for FY 2003 Carmona approved as surgeon general FTC to host Internet competition workshop Industry invited to participate in site tours NIH funds sixth botanical center CFSAN calls for food advisory committee nominees CHPA asks Customs to reconsider release period changes CHPA to speak on consumers and risk management at DIA meeting FDLI loses distinguished colleague: Frank Duckworth CFH and the nation's nurses want kids to know: Safety Rules WANTED: 2nd and 3rd shift production supervisors Use
the table of contents to jump directly to a story of interest, or use the
scroll bars. "Back to the top" options after every story will take
you to the beginning of the table of contents. |
|
|
|
Labels, not bar codes, tell consumers how to use OTCs "We want and encourage consumers to read the label, understand their medications, and [talk], when necessary, with a health professional . . . It is unlikely that the use of bar codes by consumers in the non-institutional self-care setting is reasonably feasible or preferred over the human readable printed label," wrote CHPA Senior Vice President and Director of Science and Technology R. William Soller, Ph.D., in July 26 comments to FDA. CHPA's remarks were submitted to the Agency for its public meeting to discuss bar code requirements for human drug products in an effort to reduce medication errors. CHPA reasserted its members’ commitment to reducing medication errors, but highlighted that the differences between the self-care and professional settings make changing the current bar coding system employed by the OTC industry unfeasible. The comments detailed how "Drug Facts" labeling is the means designed to address medication errors in the consumer setting; i.e., OTC labels provide all the essential information needed for the safe and effective use of products by consumers. CHPA’s comments also drew attention to the fact that OTC products already bear Universal Product Codes (UPCs). These one-dimensional codes allow companies to track many types of distribution and sales models of the same product. The UPC is often not the national drug code, and mandating such linkage would have major impact on sales and distribution systems. CHPA addressed a number of other issues that cause the Association concern, including:
To read CHPA’s full comments on bar coding, click here. CHPA contact: Dr. Bill Soller
|
|
|
|
CHPA and CTFA seek more time to change sunscreen labelsCHPA and the Cosmetic, Toiletry, and Fragrance Association (CTFA) have asked FDA to stay the effective date of four United States Pharmacopeia (USP) sunscreen name changes, from September 1, 2002, to September 1, 2003. The name changes were announced in June in an FDA technical amendment to the sunscreen monograph requiring that four new USP sunscreen names be used in labeling effective September 1. The associations' July 26 petition underscores that this provided companies only 60 days to change their labels. Although USP itself did publish the new names in March 2001 for implementation in 18 months, the associations explain in their petition that there has been considerable uncertainty about the timing of FDA plans to publish a proposed amendment to the final sunscreen monograph to address a number of outstanding issues. Under these circumstances, "it was not unreasonable for a company to wait" for FDA to act before making the labeling changes, the petition asserts. It adds that FDA has said that one of its goals in completing the sunscreen monograph is to minimize the number of label changes that will be necessary. The petition further details how a deferral of one year would allow manufacturers to move forward to make necessary label changes and avoid disruptions in the supply of sunscreen products. CHPA contact: Eve Bachrach |
|
|
|
Winkle to speak at MCS Helen Winkle joins the growing list of FDA officials confirmed to speak at CHPA’s 34th Manufacturing Controls Seminar (MCS), October 10-11 in Parsippany, New Jersey. Winkle is the acting director of the Office of Pharmaceutical Science (OPS) in FDA’s Center for Drug Evaluation and Research (CDER) and oversees a department with a broad range of responsibilities that directly impact the OTC industry. OPS is responsible for the approval of the chemistry and manufacturing controls sections of new drug applications and generic drug approvals. OPS also has FDA leadership of the process analytical technology initiative, which will have a profound effect on the pharmaceutical industry and on regulations. _______________ 34th
Manufacturing Controls Seminar _______________ Winkle is closely involved with the Product Quality Research Institute, a joint project of FDA, industry, and academia designed to apply science to the regulatory process and ease the regulatory burden on the industry. She is eminently qualified to address the MCS theme, "Looking Ahead: Balancing Regulatory Requirements." Other FDA speakers at the MCS include:
The 2002 MCS continues the value-added tradition of providing direct interaction with FDA officials involved in the regulatory process. A current program and registration information on this dynamic educational offering are available on CHPA's web site. CHPA contact: Kass Kassouf and Maria Sarabia |
|
|||
|
CHPA to examine expanding OTC access through education During two general sessions, three concurrent workshops, and untold networking opportunities, attendees at the 2002 Research & Scientific Development Conference (R&SDC) will have the chance to explore the concept of "Expanding OTC Access Through Education." The R&SDC will be held November 7-8 at the Hyatt Regency in Bethesda, Maryland. The first general session of the R&SDC will examine the role of OTC drug products in the delivery of health care, and how health care professionals learn about OTCs and advise consumers on their use. The speakers include Thomas A. Moore, chief executive officer & president, Biopure Corporation; Michael C. Alfano, D.M.D., Ph.D., dean, College of Dentistry, New York University; Janet P. Engle, Pharm.D., associate dean for academic affairs, College of Pharmacy, University of Illinois at Chicago; and Jonca Bull, M.D., director, Office of Drug Evaluation V, FDA. These speakers will be joined by Ellen Shapiro, director, Division of Public Affairs, Center for Drug Evaluation and Research, FDA, for a roundtable panel discussion. |
CHPA thanks this year’s sponsors of the R&SDC:
|
||
|
The second general session will feature a special presenter on education, motivation, and behavior, William Smith, Ed.D., executive vice president and director, Social Change Group, Academy for Educational Development. Other featured speakers are Charles J. Ganley, M.D., director of Over-the-Counter Drug Products, FDA, and Paul J. Seligman, M.D., director, Office of Pharmacoepidemiology and Statistical Science, FDA. Randy P. Juhl, Ph.D., vice chancellor for research conduct and compliance, University of Pittsburgh, will comment on consumer education and the future OTC environment and moderate a panel discussion among the session speakers. The three concurrent workshops will provide opportunities for learning and interaction among conference participants. Two will focus on consumer communication and education, and the third will explore risk management related to adverse event reports. A preliminary program and registration materials are available on CHPA's web site. Reservations should be made with the Hyatt Regency hotel directly at (800) 233-1234 or (301) 657-1234. Call by October 16 and mention the CHPA room block for the special conference rate. After that, reservations will be made on a space- and rate-available basis. CHPA contact: Dr. Lorna Totman |
|||
|
|
|
CHPA pushes for a dietary supplement ingredient safety review CHPA urged FDA July 24 that the time has come to adopt a formal dietary supplement ingredient safety review process. CHPA issued its call in response to the release of the Institute of Medicine’s (IOM’s) draft Proposed Framework for Evaluating the Safety of Dietary Supplements. The draft proposal comes at the request of FDA’s Center for Food Safety and Applied Nutrition (CFSAN), which, along with the U.S. Federal Trade Commission, has regulatory authority over dietary supplements. The IOM proposal provides a framework to review the safety of all dietary supplements, including screening, prioritization, and in-depth reviews of particular dietary supplement ingredients. "Dietary supplements are an important part of consumers’ self-care practices," CHPA Senior Vice President and Director of Science and Technology R. William Soller, Ph.D., stated. "CHPA is supportive of IOM’s science-based approach and considers it to be an appropriate and logical progression for safety reviews consistent with the Dietary Supplement Health and Education Act of 1994. Now the time is right for CFSAN to formally adopt the proposed framework into its existing regulations." The IOM report is in line with the Association’s "Dietary Supplement Ingredient Safety Review," or DSISR, process recommended in the fall of 2001. "CHPA members have long been actively working to further enhance consumer confidence in the safety of these important self-care products. The DSISR fits the bill, as does the IOM framework in principle, by addressing both pre- and post-marketing safety issues," concluded Soller. CHPA contact: Dr. Bill Soller |
|
|
|
Congressional committees approve FDA funding for FY 2003 Senate and House appropriations committees have approved separate bills to fund FDA for fiscal year (FY) 2003 at nearly $1.4 billion. The Senate would give the Agency approximately $16 million more than the House. Both bills would fund FDA's Center for Drug Evaluation and Research and related field activities at $279.5 million, an increase of over $34 million from the current fiscal year. The appropriations committees made several recommendations regarding the allocation of resources for dietary supplement activities. For example, the Senate Appropriations Committee stated that it is essential for FDA to continue its efforts to ensure the safety of dietary supplements and designated $1.5 million to continue the improvement of an adverse event reporting system for products that are regulated under the Dietary Supplement Health and Education Act. The Senate committee also recommended $2 million to continue the work of the National Center for Natural Products Research to identify and analyze specific components of dietary supplement ingredients, including botanicals. The House Appropriations Committee directed FDA to take all appropriate action to expeditiously enforce recently enacted prohibitions on the labeling of certain products as "Siberian ginseng." (See the July 19 XNL.) The House committee also agreed that the U.S. Department of Health and Human Services-sponsored comprehensive review of the scientific basis for assessing the safety of products containing ephedra is the appropriate response to concerns raised by adverse event reports. (See the June 21 XNL.) The committee further commended FDA for working with the Institute of Medicine to develop a framework for evaluating the safety of six dietary supplements (See related story) and requested that the framework be expanded to include safety evaluations of additional ingredients. In related developments regarding federal government funding bills, the Senate Appropriations Committee:
CHPA contact: Kevin Kraushaar |
|
|
|
Senate fails to pass Medicare drug benefit legislation After two weeks of debate and separate votes on four competing proposals, the Senate failed to approve a prescription drug benefit for Medicare beneficiaries prior to its August recess. However, by a vote of 78-21, the Senate did approve legislation that includes a controversial amendment to the Hatch-Waxman statute that would allow a private cause of action to challenge patents listed in the Orange Book. The bill also would ease restrictions on the reimportation of U.S.-made drugs, provide $9 billion to states to help with soaring Medicaid and social services expenses, and authorize states to establish programs designed to extract discounts from pharmaceutical companies to lower drug costs for residents who may not be eligible for Medicaid. The Senate bill did not contain an amendment that was discussed at the committee level that was intended as an "enforcement mechanism" should FDA force the switch of a drug from prescription to nonprescription status over the objection of the sponsor. The amendment would have made it illegal to market the same drug under both prescription and nonprescription status. The bill now goes to the House where it faces an uncertain future. The House has already approved a Medicare prescription drug bill, but it did not contain any of the other drug provisions contained in the Senate-passed version. A House committee may hold hearings in September on the drug reimportation issue, but no decisions have been made on efforts to amend the Hatch-Waxman law. Proponents of the Senate-passed version are expected to offer the bill as an amendment to related legislation in the House. CHPA contact: Kevin Kraushaar |
|
|
Carmona approved as surgeon general The U.S. Senate unanimously approved Richard Carmona, M.D., as the nation's surgeon general July 23. Carmona is a professor of surgery at the University of Arizona, and has stated that his primary areas of focus as "America's doctor" in will be preventative health and the bioterror threat. The surgeon general serves as the leading U.S. spokesperson on matters of public health, and is part of the U.S. Department of Health and Human Services. |
|
|
|
FTC to host Internet competition workshop The U.S. Federal Trade Commission (FTC) plans to hold a public workshop this fall on how state regulations may have anticompetitive effects, and how certain e-commerce practices may raise antitrust concerns. There will be a health care/pharmaceuticals/telemedicine panel. The workshop will take place October 8-10 at FTC headquarters in Washington, D.C. More information is available on the FTC's web site. |
|
|
|
Industry invited to participate in site tours FDA's Center for Drug Evaluation and Research (CDER) announced in the July 26 Federal Register the continuation of its 1999 Regulatory Project Manager Site Tours program. The goal of the program is to improve CDER's regulatory staff's understanding of pharmaceutical industry operations and enhance Agency-industry communication. Companies wishing to host CDER staff in their facilities should submit proposed agendas by September 9. |
|
|||
|
NIH funds sixth botanical center The National Institutes of Health (NIH) announced July 25 a five-year, $6 million grant for the development of a research center in Iowa to study echinacea and St. John's wort. The new Center for Dietary Supplement Research will be located in Ames, Iowa. The five other NIH-funded centers studying various dietary supplements are located in California, Illinois, Missouri, Alabama, and Arizona.
|
|
|
|
CHPA asks Customs to reconsider release period changes CHPA asked the U.S. Customs Service August 2 to reconsider its proposed rule to extend the conditional release period for imports of FDA-regulated products by six months. Under the Food, Drug and Cosmetic Act, food, drug, device, and cosmetics imports can be released by the Customs Service to the owner on a conditional basis while FDA considers whether they are, in fact, admissible, and if the importer posts a bond. If FDA determines that an article is not admissible, Customs can demand the article be returned to the agency’s custody or receive liquidated damages. On June 7, Customs proposed that such a demand for redelivery could be made up to 210 days after release, six months beyond the current one-month practice. CHPA noted the impracticability of such a lengthy time period, and pointed to other developments to improve Customs and FDA inspections of FDA-regulated products at port. CHPA contact: Dave Spangler |
|
|
|
Tokyo assembly approaches The World Self-Medication Industry General Assembly is set for November 12-16 in Tokyo, Japan, on the theme, "Beyond the conventional boundary of self-medication." In both developed and developing countries around the world, self-medication has been and will be playing an important role in helping governments build a responsible health care framework within which to structure national drug policies to promote public health. The assembly offers an opportunity to discuss where self-medication is headed: regionally, nationally, and globally. For more information on the assembly, contact CHPA’s Sandra Archer for a preliminary program and registration forms, or e-mail wsmi@ics-inc.co.jp. |
|
|
|
CHPA to speak on consumers and risk management at DIA meeting CHPA Senior Vice President and Director of Science and Technology R. William Soller, Ph.D., will take on the subject of the consumer as a co-risk manager at the Drug Information Association's (DIA's) upcoming meeting. "The Changing Rx/OTC Environment and Implications for Assessing Safety and Efficacy" conference will take place September 17-18 in Washington, D.C. It is designed to examine the current paradigm of switches and look at methods for reducing barriers to bringing products to market. DIA's web site has more information. |
|
|
|
FDLI loses distinguished colleague: Frank Duckworth Frank Duckworth, former president of the Food and Drug Law Institute (FDLI), died in his home in Vienna, Virginia, July 26. He was 80 years old. Mr. Duckworth held a degree in pharmacy as well as both a J.D. and Masters in law. He arrived at FDLI upon his retirement from Pfizer Inc. and served as the institute's president until 1990. The Duckworth family suggests that contributions be made to the University of Florida College of Pharmacy (P.O. Box 103570, Gainesville, Florida 32610) or the Fredric Levin College of Law at the University of Florida (P.O. Box 117623, Gainesville, Florida 32611). |
|
|
|
CFH
and the nation's nurses want kids to know: Safety Rules With back-to-school season drawing near, the Council on Family Health (CFH) and the National Association of School Nurses announce the publication of Safety Rules, an activity booklet designed for younger elementary school children. With a colorful cover, tear-out ruler, games, and plenty of space for coloring, Safety Rules offers easy-to-understand messages on bicycle, pedestrian, and school bus safety, as well as general guidelines for bringing medicines to school. The program includes an 11" x 17" companion poster to reinforce some of the core safety messages for display in schools, nurses’ offices, and other areas where young children gather. The Safety Rules activity booklet and poster can be ordered from the Council's web site. |
|
|
|
WANTED: 2nd and 3rd shift production supervisors A producer of private label OTC medications is seeking candidates for multiple production supervisor positions for its 2nd and 3rd shift operations. The company, headquartered in southwest Michigan, is a manufacturer of FDA-regulated drug products in liquid, tablet, and other dosage forms. The persons selected for these positions will possess a minimum of two years’ supervisory experience in manufacturing, strong problem-solving and leadership skills, and a Bachelor’s degree or equivalent in business or a technical field. Experience in an FDA-regulated industry (foods, pharmaceuticals, personal care products) is preferred. Job duties include assigning work, scheduling operators and other production employees, managing department and individual performance, monitoring quality and productivity, and resolving production problems. Positions are available in both packaging and manufacturing departments. The selected individuals must be committed to working on either 2nd or 3rd shift, and will be eligible for shift premium, discretionary overtime pay, and company bonus. For more information, e-mail prorecruitment@axiosincorporated.com. |
|
|
Systems Inspections 2002: FDA/Industry Workshop August 5, 2002 Manhattan Beach Marriott Manhattan Beach, California Contracting
& Outsourcing: Conference & Tabletop Exhibition 2002 Manufacturing Controls Seminar Research & Scientific Development
Conference |
|
|
|
| Executive Newsletter is published every other week by the Consumer Healthcare Products Association |
| 1150 Connecticut Avenue, NW, Suite 1200, Washington, DC 20036 |
| Tel: (202) 429-9260 |
| Fax: (202) 223-6835 |
| Web site: www.chpa-info.org |
| Forward contact information changes to CHPA's Membership Department. |
| Forward editorial comments or questions to CHPA's Public Affairs Department. |
| |
| |
| |
| Copyright © 2002 by the Consumer Healthcare Products Association (CHPA). CHPA's Executive Newsletter is for general information purposes only. Information reported in this newsletter is compiled from various sources. All efforts are made to assure the accuracy of the content, but CHPA cannot guarantee the information. | |
| http://www.chpa-info.org | |
| |
