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July 30, 2004 |
No. 15-04 |
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CONTENTS CHPA urges FDA to restrict toll-free number labeling proposal to Rx drugs Meth Watch programs now taken back to the states Industry coalition gives its two cents on Part 11 Former EPA Administrator Christine Todd Whitman to headline second day of MCS Logistics Steering Committee explores the EPC/RFID initiative The 2004 CHPA Market Exchange is closer than you think Regulatory and Scientific Conference moves to May FDA proposes shift to complete response letters Drug sponsors can now use new FDA standard format to submit clinical data Outdated industry guidances withdrawn New law calls for labeling of major food allergens CHPA staff travel inside the Beltway and beyond Landa named deputy director of regulatory affairs for CFSAN FDA offers audio alert on change control IVT conference focuses on risk assessment and management
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CHPA urges FDA to restrict toll-free number labeling proposal to Rx drugs CHPA filed comments July 21 urging FDA to revise a rule proposed in April (see April 22 XNL) that would require the labeling of every human drug product under an approved application, including certain OTCs, to include:
The proposed rule is intended to bring FDA regulations into compliance with the Best Pharmaceuticals for Children Act (BPCA). Under the proposal, affected entities would have one year following the effective date of any final rule, or a total of 13 months, to be in compliance. In its submission, CHPA stated that it recognizes the importance of obtaining complete and accurate adverse event data for drug products and has actively supported the mandatory reporting of adverse events for OTC drugs. The Association argued, however, that as proposed, the rule fails to fulfill the goals of the BPCA in the following important respects:
CHPA additionally pointed out that the Agency underestimated the number of stock keeping units (SKUs) affected by the proposed rule, as well as the potential compliance costs involved to revise the product labeling of affected SKUs. CHPA contact: Paul Larsen
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Meth Watch programs now taken back to the states CHPA's launch of the national Meth Watch program received high accolades from states that participated in the Meth Watch training seminar earlier this month (see July 16 XNL). Indiana, one of the 20 states represented at the seminar, announced the launch of its own Meth Watch program earlier this week, while other states have secured meetings with their respective government officials and community leaders. Participants at the training seminar were asked to submit a brief evaluation of the session. CHPA received an overwhelming amount of positive feedback, including these comments from a law enforcement representative from North Carolina:
Retail representatives also shared their enthusiasm and encouraged CHPA to remain in continued contact and coordinate regional outreach meetings. Next week, Meth Watch travels to the Community Anti-Drug Coalitions of America's mid-year training seminar in Chicago, Illinois. CHPA will be on hand to further promote the Meth Watch program to over 400 coalition members, prevention specialists, and others involved in community efforts to build safe, healthy, and drug-free communities at the conference. CHPA contacts: Elizabeth Assey and Virginia Cox |
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Industry coalition gives its two cents on Part 11 CHPA, along with other Industry Coalition on 21 CFR Part 11 members, presented comments to FDA at a July 8 public meeting convened by the Agency to gather input on Part 11, its rule governing electronic records and signatures (see April 8 XNL). In its submission, the coalition maintained that "prescriptive regulation of computer technology tools used in the manufacture of regulated products is neither practical nor enforceable." The coalition cited the following reasons to support its premise:
The coalition pointed out that the significant and still relevant portions of the rule are already contemplated and interpreted as acceptable practice within the predicate rules and recommended that clarification, if necessary, should be provided with appropriate guidances. Finally, the industry coalition recommended that FDA rescind the rule and called on Part 11 solution providers to refocus their efforts and help the industry and regulators meet their objectives by:
CHPA contact: Fred Razzaghi |
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Former EPA Administrator Christine Todd Whitman to headline second day of MCS
Extremely active in Republican politics, Whitman was appointed EPA administrator by President George W. Bush in January 2001. Prior to leading the EPA, Whitman served as the 50th governor of New Jersey, the first female ever to be elected and re-elected to that state's highest office, where she developed a strong environmental record. She also had an impressive showing in a run for a U.S. Senate seat in 1990 against incumbent Bill Bradley. Despite the prevailing view that New Jersey may not be the most environmentally-friendly state in the union, as a long-time rural resident, Whitman has always been a friend of the environment in a state with a large pharmaceutical industry sector. Her public service as the governor of New Jersey and administrator of EPA uniquely qualify her to bring a keen understanding of the issues of a state's economic well-being, as well as effectively managing risks to public health at the federal level. As one of the states largest employers, the pharmaceutical manufacturing segment continues to be in transition. The initiative to move toward risk-based regulation and investment in technology will help to maintain the industry's competitive economic advantage. Ensuring outcomes that meet both the economic and public health objectives of CHPA's members, as well as those of the regulators, require an understanding of the issues that Whitman will address at the MCS with special insight.
A registration form for the MCS is available in the Meetings section of www.chpa-info.org. Program materials will be made available shortly. Individuals planning to attend the MCS should contact the Hilton Parsippany directly at (877) 671-5746 and mention the CHPA room block. CHPA contact: Fred Razzaghi |
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Logistics Steering Committee explores the EPC/RFID initiative The CHPA Logistics Steering Committee (LSC) convened June 29-30, in the Boston, Massachusetts, area. The group assembled first at The Gillette Company, a leader and early adopter of Electronic Product Code (EPC) and Radio Frequency Identification (RFID) technology. Chris Desrosier, director, Customer & Business Development, Auto-ID, briefed the group on Gillette's work—past, present, and future. During the second day of the meeting, LSC Chair Bob Wigmore, vice president, Supply Chain Logistics, Wyeth Consumer Healthcare, introduced a presentation by VeriSign. VeriSign was selected by EPCglobal Inc to provide and manage the object-naming service for the EPC Network. EPC can handle massive RFID-driven data flow and will be a key data integrator as RFID gains acceptance. Trent Peterson, director of Solutions Development, presented the Verisign solution to the LSC. The committee then traveled to the Auto-ID laboratory at the Massachusettes Institute of Technology (MIT). For more than four years, MIT's Auto-ID Center has been developing supply chain applications for RFID technology that promise to deliver significant benefits to the economy and consumers. The Auto-ID Center has performed exhaustive work on the development of EPC—a radio-enabled bar code that can read wirelessly. EPC is the next generation of the universal product code. Within the healthcare and consumer products industry, the benefits of the EPC/RFID initiative include elimination of manual counting and recounting products in distribution. Out-of-stocks could virtually be eliminated through pre-set triggers that automatically call for replenishment. The committee learned that there are both retailer and manufacturer pilot studies underway in the industry and while unit-level tracking at the store level is years away, many retailers are eager to adopt case- and pallet-level tagging to enhance supply chain efficiencies. Members may access a copy of Desrosier's and Peterson's presentations in the Members Only section of www.chpa-info.org. CHPA contact: Ted Peterson |
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The 2004 CHPA Market Exchange is closer than you think
If you have not yet registered for the Market Exchange event, please visit the Members Only section of www.chpa-info.org. Contact Susan DiBartolo if you need assistance accessing this restricted area. For questions concerning registration, contact CHPA's Maria Sarabia. CHPA contacts: Ted Peterson and Phyllis Taylor
Regulatory and Scientific Conference moves to May
CHPA contact: Dr. Lorna Totman |
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FDA proposes shift to complete response letters FDA issued a proposed rule in the July 20 Federal Register to stop use of approvable or not approvable letters for new drug applications (NDAs) and abbreviated new drug applications (ANDAs). Instead, the proposal calls for the use of complete response letters to indicate that an application is not ready for approval. The Agency also is revising user fee-related review cycle rules. While the user fee goals do not apply to ANDAs, FDA is proposing similar changes. Efficacy supplements would be treated the same way as NDAs. The Agency's actions are related to 1997 and 2002 Prescription Drug User Fee Act targets or goals. FDA has used not approvable letters when deficiencies in an NDA or ANDA were major; otherwise it has used approvable letters. But the Agency believes the distinction has become blurred and complete response letters are more neutral, with no implication as to the ultimate approvability of an application. Under the proposed rule, FDA would send a complete response letter if it determines that it will not approve an application in its present form. The letter likely would describe specific deficiencies in the application, allowing an applicant to either resubmit the application, addressing deficiencies identified in the letter; withdraw the application without prejudice; or request a hearing. In resubmitting, FDA would follow classification criteria to trigger either a two-month or six-month review cycle. FDA also notes that it can approve an application and issue an approval letter when “minor labeling deficiencies remain,” so neither approvable letters nor complete response letters would be necessary in that circumstance. Comments on the proposal are due by October 18. CHPA contact: David Spangler |
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Drug sponsors can now use new FDA standard format to submit clinical data FDA announced July 21 that the Clinical Data Interchange Standards Consortium (CDISC) has developed a standard model for the Agency that drug sponsors can use to submit human drug clinical trial data. According to an FDA news release, the new standard format, called the Study Data Tabulation Model (SDTM), provides a consistent framework for submitting information that should lead to greater efficiencies in clinical research and Agency reviews of new drug applications. In addition, FDA stated that SDTM will help automate the largely paper-based clinical trials research process and foster easier communication and collaboration among clinical researchers. FDA plans to add the SDTM format to the Agency draft guidance, Providing Regulatory Submissions in Electronic Format–Human Pharmaceutical Applications and Related Submissions. More information on CDISC and the SDTM is available at www.cdisc.org. |
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Outdated industry guidances withdrawn The July 20 Federal Register included a notice from FDA stating that the Agency is withdrawing a total of six industry guidances on the clinical evaluation or requirements for approval of certain classes of drugs. The affected classes of drugs include antacids, antidiarrheals, laxatives, and gastric secretory depressants. According to the Agency, the guidances, developed during the 1978-1981 timeframe, are outdated and of little use to the industry. FDA noted that it has since developed other guidances and resources for industry on these classes of drugs. |
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New law calls for labeling of major food allergens A new law, recently sent to President George W. Bush for signature, is designed to protect the approximately two percent of adults and five percent of children who suffer from food allergies. The Food Allergy Labeling and Consumer Protection Act of 2004 will require, by January 1, 2006, a food product, including dietary supplements, to be labeled if it is or contains an ingredient that is considered to be a major food allergen. The law specifies that eight major food allergens, believed to account for about 90 percent of food allergies, be identified using “plain English” on the food label when ingredients contain allergenic substances. The eight food allergens identified by the law are milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. Because the names of some ingredients may be unfamiliar to consumers or do not clearly identify that a particular food ingredient is the source of an allergen, labeling will require the food product to either bear a statement that the product “contains” one of the eight major food allergens or list the potential food allergen in parentheses immediately after the food ingredient containing the allergen in the ingredient statement. This law also requires food allergen labeling of any flavor, color, or incidental additive that is or contains a major food allergen. CHPA contact: Dr. Doug Bierer |
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CHPA staff travel inside the Beltway and beyond CHPA Vice President for Corporate Development Ted Peterson, Assistant General Counsel Paul Larsen, and Membership & Corporate Development Manager Phyllis Taylor, traveled to Miami, Florida, the week of July 19 to represent CHPA at the Joint Industry Unsaleables Management Conference co-sponsored by CHPA, the Food Marketing Institute, the Grocery Manufacturers of America, and the National Association of Chain Drug Stores. The three-day event drew over 200 executives from around the country. Several CHPA Active member companies participated in the event including representatives from Bayer HealthCare, LLC; Blixtex Inc.; Church & Dwight Co., Inc.; Pfizer Inc; The Procter & Gamble Company; Schering-Plough HealthCare Products, Inc.; and Wyeth Consumer Healthcare. Retailers included Albertsons, Food Lion, Harris Teeter, HEB, Rite Aid, Walgreens, and Winn-Dixie. Presentations from both retailers and manufacturers focused on reducing returns through communication, technology, package design, and structured benchmarking... CHPA Director of Government Relations Nancy Bukar, and Government Relations Counsel Jennifer Hawks Bland, were in Salt Lake City, Utah, July 20-22 at the National Conference of State Legislators annual meeting and exposition where they attended a session on methamphetamine problems and solutions... |
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Landa named deputy director of regulatory affairs for CFSAN Acting FDA Commissioner Lester M. Crawford, D.V.M., Ph.D., announced in a July 15 Agency news release the appointment of Michael M. Landa, as deputy director of regulatory affairs for the Agency's Center for Food Safety and Applied Nutrition (CFSAN). Landa's FDA career experience includes serving as FDA's deputy chief counsel since January 2000, including a stint as acting chief counsel from March 2001 to August 2001. In addition, Landa was associate chief counsel for medical devices, enforcement, and veterinary medicine during various periods between 1978 and 1993. He received his J.D. from the University of Virginia and is a member of the District of Columbia Bar. |
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FDA offers audio alert on change control FDA is hosting a live, interactive audio alert session August 5 from 1:30 to 3:00 p.m. (EDT) on the best practices in change control for processes, facilities, utilities, equipment, computers, raw materials, and documents. The instructor of the 90-minute session, Barbara Immel, president of Immel Resources LLC, will teach participants how to maintain a state of control despite ever-changing demands, better educate employees on change control concepts and requirements, and supply FDA with proof of compliant, well-managed changes. In addition, each registered site will receive a white paper with 10 practical tips for establishing, implementing, and improving a change control system. For more information on the audio alert or to register, click here. |
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IVT conference focuses on risk assessment and management The Institute of Validation Technology (IVT) is holding a conference on risk assessment and management August 17-19 in Philadelphia, Pennsylvania. Sixteen risk experts from the pharmaceutical and medical device industries will be featured in a series of interactive workshops, expanded sessions, and general sessions. Conference topics include new FDA initiatives and global views, risk-based validation, and key risk assessment tools. For more information, refer to the program brochure or e-mail registration@ivthome.com. |
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CHPA Market Exchange
Manufacturing Controls Seminar
Business
Development Conference
2005 CHPA
Annual Executive Conference
2005 Regulatory & Scientific Conference |
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| Executive Newsletter is published every other week by the Consumer Healthcare Products Association |
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| Copyright © 2004 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 | |
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Christine
Todd Whitman, former administrator of the U.S. Environmental
Protection Agency (EPA), will speak on the second day of CHPA's Manufacturing
Controls Seminar (MCS) now scheduled for September 30 to October 1 at the
Hilton Parsippany in Parsippany, New Jersey. 
