CHPA Business Development Conference scheduled in Bentonville

Mark your calendars now for the 2003 CHPA Business Development Conference, to be held October 27-28 at the Clarion Hotel in Bentonville, Arkansas. The conference program will be heavy with input from local retail giant Wal-Mart. It will feature presentations and interaction with Wal-Mart's OTC merchandising team lead by Chuck Fehlig, merchandise manager, Wal-Mart Stores, Inc. The program also will include representatives from Wal-Mart's supply chain group to review data synchronization (UCCNet) and radio frequency identification issues. Additionally, after the conference, attendees are encouraged to schedule individual meetings with Wal-Mart buyers.

This meeting is open to CHPA members only. A program brochure and registration materials will be available in July. 

CHPA contact: Ted Peterson

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CHPA launches second front in war against meth

For the second time this month, CHPA has teamed up with the Partnership for a Drug-Free America (PDFA) and pediatricians in the ongoing war against methamphetamine. On June 26, CHPA, PDFA, and the Arizona Chapter of the American Academy of Pediatrics launched a two-year health educational campaign to teach parents and teenagers in the Phoenix area about the serious health risks associated with the abuse of meth and club drugs. A similar program was launched with PDFA and the Missouri Chapter of the American Academy of Pediatrics in St. Louis June 10. (See June 12 XNL.) 

Phoenix was selected as the second pilot market for this campaign because the city’s teen drug abuse statistics are much higher than the national average. The overall goal of the health education campaign is to reduce drug use among teenagers in both pilot markets and to strengthen anti-drug attitudes by encouraging open and honest dialogue about drugs between parents and their kids.  

CHPA contact: Donna Edenhart

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Register online for CHPA MarketPlace 2003 Business Exchange

The Association is pleased to announce that attendees now have two ways to register for the inaugural CHPA MarketPlace 2003 Business Exchange event: via fax or, now, online. Registration forms and details are available for this exclusive CHPA member business forum in the members-only section of www.chpa-info.org. 

The appointment scheduling process has already begun, so don’t wait to register. And remember: Companies sending six or more registrants are eligible for a $50 discount per person.

A registration list of table hosts and attendees will be posted on the CHPA web site in early July. It will be updated on a regular basis for your convenience. 

CHPA contacts: Ted Peterson and Phyllis Taylor 

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Agency issues direct final rule on skin protectant astringent OTCs

FDA issued a direct final rule in the June 13 Federal Register amending the monograph for skin protectant astringent OTC drugs. Since the Agency does not view the subject matter in this regulation to be controversial, it opted to issue a direct final rule. It also issued a companion proposed rule on the same day for procedural reasons.

The final rule revises some of the older label warning statements and directions on affected products and conforms them to the Drug Facts label format. The rule does include labeling exemptions for styptic pencils, however. The effective date of the rule is October 27. The compliance date is either the first major labeling revision after the effective date of October 27 or by June 13, 2005, whichever is earlier. 

CHPA contact: Dr. Lorna Totman

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FDA rules on generic drug stays and reviews procedures

As part of its Generic Drugs Initiative, FDA issued a final rule June 18 designed to streamline the approval process for generic drugs. The rule—which will be effective August 18—allows for only one 30-month stay should an innovator drug company sue a generic manufacturer over patent issues. It also prohibits the submission of patents on the basis of packaging, intermediates, or metabolites.

Additionally, FDA is modifying its internal systems to improve the efficiency with which it reviews generic drugs. FDA seeks to use a proposed budget increase to hire 40 additional staff to review generic drug applications and create a system whereby the Agency communicates earlier with generic manufacturers to facilitate the filing of complete applications during the initial review. 

CHPA contact: Eve Bachrach

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CFSAN makes some management changes

FDA Center for Food Safety and Applied Nutrition (CFSAN) Director Joseph A. Levitt has made some management changes within his center to better address food security and applied nutrition priorities. 

To coordinate food security and counter-terrorism activities among CFSAN, other FDA centers, the Department of Health and Human Services, other federal and state agencies, and stakeholders, Levitt has appointed Dr. Robert Brackett director of CFSAN’s food safety and security staff. On the applied nutrition front, Levitt has created a new position on his senior management team: senior advisor for applied nutrition. That senior spot will be temporary staffed by current Office of Food Additive Safety Director Dr. Alan Rulis. Until a permanent employee fills that position, Rulis will focus on FDA’s Consumer Health Information for Better Nutrition Initiative. (See December 20, 2002, XNL.) 

CHPA contact: Dr. Doug Bierer

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House committee supports a $700,000 increase for OTCs

The House Appropriations Committee approved by voice vote June 25 a bill for fiscal year 2004 that contains an increase of $700,000 for OTC drug programs at FDA. The Bush Administration had requested an extra $1 million dollars be allocated for OTCs at the Agency, a request supported by CHPA.

According to the committee’s report, the OTC funding would allow the Agency to hire and train five additional employees to assist with:

• improving the OTC drug review process, 
• finalizing OTC drug monographs, and 
• conducting consumer behavior research in the Agency’s ongoing risk management efforts. 

Further, the House committee recognized in its report the importance of switch and recommended that FDA’s first priority regarding switch should be to finalize switch applications already under review. The committee also voiced its opinion that the OTC appropriation should be used to “improve on the long history of cooperation between the Agency and switch applicants.”

The committee bill appropriates $1.389 billion in total for FDA, which is $15.5 million above the previous fiscal year but $5.4 million below the president’s request. The bill now goes to the House floor and the full Senate is expected to report its own bill when Congress reconvenes after the July 4 recess. 

CHPA contact: Kevin Kraushaar

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FDA tests program to post warning letter responses on fda.gov

The June 23 Federal Register included a notice of the Agency’s intention to pilot test a new program of posting online responses to warning letters it issues. The six-month test will post only those responses which companies have requested be posted on www.fda.gov. FDA views this new feature as part of its efforts to make its process open and transparent. Warning letter recipients that wish their responses to be made publicly available in this way should request to be included in this pilot program and supply their responses in a word processing format either on disk or CD. FDA states it will not post a response that “would likely mislead the public concerning the safety or efficacy of a company’s product(s).” 

CHPA contact: Fred Razzaghi

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CPSC asks for input on CR test failure criteria

The Consumer Product Safety Commission (CPSC) is asking for comments on how it should define child-resistance (CR) test failure for unit-dose packaging. The current approach used by the commission is to define a failed CR test for unit-dose packaging as one in which a child gains access “to the number of individual unit doses that constitute the amount that ‘may cause serious personal injury or serious illness’ or more than eight individual unit doses, whichever is less.”

CPSC’s request stems from a citizens petition from the Healthcare Compliance Packaging Council (HCPC) suggesting that the definition of test failure be more objective. Specifically, HCPC formally recommended May 5 that CR test failure for unit-dose packaging be defined by the following criterion: “any child who opens or gains access to more than eight individual units during the full 10 minutes of testing.”

Comments should be captioned Petition PP 03-01, Petition for Amendment of the Child-Resistance Testing Requirements for Unit Dose Packaging, and e-mailed to cpsc-os@cpsc.gov. 

CHPA contact: Fred Razzaghi

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FDA extends comment period on safety reporting proposal

FDA announced in the June 18 Federal Register that it is extending the comment period by three months on the proposed rule for safety reporting requirements for drugs. Stakeholders now have until October 14 to respond to the March 14 proposal that describes amendments to pre- and post-marketing safety reporting regulations for drugs under new and abbreviated new drug applications. The proposal seeks to both improve the quality and usefulness of safety reports submitted to the Agency as well as to facilitate the consistency of safety reporting around the world.

CHPA contact: Dr. Lorna Totman

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TSE advisory committee will meet in July

FDA announced June 16 the next meeting of its Transmissible Spongiform Encephalopathies (TSE) Advisory Committee. The committee will meet July 17-18 in Bethesda, Maryland. The first day of the meeting will discuss the safety of bovine bone gelatin in drugs, foods, and cosmetics; any potential implications on FDA-regulated products stemming from the one instance of mad cow disease in Canada; and the decontamination of medical equipment and facilities. Day two will be devoted to reprocessing methods for medical devices and facilities and equipment decontamination in the preparation of human cellular, tissue, and blood products. 

CHPA contact: Dr. Lorna Totman

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CHPA staff travel inside the Beltway and beyond

CHPA Senior Vice President, General Counsel, and Secretary Eve Bachrach, Vice President of Regulatory and  Scientific Affairs Doug Bierer, Ph.D., and Senior Director of Scientific Affairs and Toxicology Lorna Totman, Ph.D., attended an FDA meeting on "Evaluating Drug Names for Similarities: Methods and Approaches." The June 26 meeting was cosponsored by the Institute for Safe Medication Practices and the Pharmaceutical Research and Manufacturers of America...

CHPA President Linda Suydam traveled to New York City June 12 to present a special award to Marc Robinson, president, consumer healthcare, Pfizer Inc. The presentation was made at the 2003 Consumer Products "Good Scout" Award Luncheon...

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California company seeks procurement director

A Southern California manufacturer of branded and private-label consumer products is seeking a director of procurement. The position will be responsible for a number of areas, including assessing the strengths, weaknesses, and competencies of suppliers and implementing strategies to optimize the entire supply chain as the organization grows. The ideal candidate will have experience in supply chain and procurement with a consumer package goods company. Interested parties may contact Dave Hamilton for more information or visit the Members Only section of www.chpa-info.org to view the entire job board. 

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CHPA to represent U.S. pharmaceutical industry at ICH in Brussels

A notable topic at the upcoming International Conference on Harmonization (ICH) Steering Committee and Expert Working Group meetings in Brussels in July is FDA’s pharmaceutical Good Manufacturing Practices initiative. CHPA, along with other expert organizations, will represent the U.S. pharmaceutical industry view at the meetings. CHPA will be working in concert with FDA to develop a consensus position towards harmonization. 

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FDA/Industry Summer Workshop
July 14, 2003
San Juan Marriott Resort & Stellaris Casino
San Juan, Puerto Rico

FDA/Industry Summer Workshop
August 12, 2003
Hyatt Regency Chicago
Chicago, Illinois

CHPA MarketPlace 2003: The First CHPA Business Exchange
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

CHPA 2003 Business Development Conference
October 27-28, 2003
Clarion Hotel
Bentonville, Arkansas

Regulatory and Scientific Conference
November 6-7, 2003
The Fairmont Washington
2401 M Street, NW
Washington, D.C.

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