Westlaw® models new product after cutting-edge CHPA member service

Under the heading, “Imitation is the highest form of flattery,” West Publications has launched a new product modeled after CHPA’s members-only “State Laws Affecting CHPA Member Products” service. This exclusive service was developed in 2001 by CHPA’s State Government Relations department in a novel collaboration with Westlaw®. It provides Association members with direct access from the members-only section of www.chpa-info.org to summaries of state laws affecting the industry and links to the actual text of hundreds of state laws and regulations that impact the industry. “State Laws Affecting CHPA Member Products” is a one-stop shop for legislative information from the states on drug manufacturer and wholesaler licensing requirements, restrictions on ephedrine, laws addressing flea market sales, status of low-dosage codeine-containing cough syrups, and more. West is now marketing this concept for use by other trade associations in other regulated industries. Its sales materials even feature a sample of CHPA’s web site.

CHPA contact: Star Alterman

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European Commission acts on pharmaceutical legislation, adopts proposal for herbal products directive

The European Commission formally transmitted the final portion of its amended proposal April 24 on the European Union’s (EU's) pharmaceutical legislation package to the Council of Ministers. The Association of the European Self-Medication Industry (AESGP) notes that the EU’s Health Ministers hope to reach agreement on a common position the first week in June. This timetable could allow ultimate adoption prior to EU expansion, which could complicate adoption.

Areas are of particular interest for OTC medicines:

• Exclusivity: The commission accepted an amendment proposed by the European Parliament (EP) to allow a one-year extension to 10-year data exclusivity for new indications “held to bring a significant clinical benefit in comparison with existing therapies.”  The commission trimmed the EP's proposed amendment to allow three years of exclusivity for switches with significant pre-clinical and clinical trials to two years.

• Classification:  The commission agreed to the heart of an EP-proposed amendment on the role of Rx or OTC classification in the mutual recognition procedure and summary of product characteristics, with classification to be taken “seriously into account.” This maintains flexibility for companies in Rx or OTC classification among Member States. The commission rejected another EP proposed amendment to make classification mandatory in the mutual recognition procedure.  

• Labeling Clarity: The commission accepted three proposed amendments from the EP on label testing, with the directive now requiring that a leaflet’s legibility, clarity, and ease of use be assessed in consultation with target patient groups. The intent is to allow companies to create more user-friendly leaflets.  

• Advertising: The commission rejected an EP-proposed amendment which would have required OTC ads to include a reference to consulting a doctor, noting the amendment would not be appropriate for OTCs.

In separate action, the commission adopted its amended proposal for a directive on herbal medicinal products April 9 (see December 6, 2002, XNL). The objective of the directive is to simplify the registration of these products by allowing their approval based on bibliographic or expert evidence. At press time, the commission’s amended proposal is not posted to the relevant web sites, but more information is available through at http://europa.eu.int/prelex/rech_simple.cfm?CL=en (Use search term COM, year 2002, number 1).

CHPA contact: David Spangler

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Consumer representatives sought for FDA advisory committees

FDA is seeking nominations for voting and nonvoting consumer representatives to fill vacancies on  advisory committees and panels to several Agency divisions including the Center for Drug Evaluation and Research (CDER). The advisory committees to CDER in need of consumer representatives are: the Arthritis Advisory Committee, the Oncologic Drugs Advisory Committee, the Peripheral and Central Nervous System Drugs Advisory Committee, the Advisory Committee for Pharmaceutical Science, and the Psychopharmacologic Drugs Advisory Committee.

In the April 23 Federal Register announcement, FDA stated that it encourages adequate representation from women, minority groups, and individuals with disabilities on the committees and that all  candidates must: 1) demonstrate ties to consumer and community-based organizations; 2) be able to analyze technical data; 3) understand research design; 4) discuss benefits and risks; and 5) evaluate the safety and efficacy of products under review. In addition, nominated persons must be able to represent the consumer perspective, serve as a liaison between the committee and interested consumers and consumer organizations, and facilitate dialogue on scientific issues that affect consumers.

Nominations for current and future advisory committee vacancies will be accepted through December 31. For more information, contact FDA's Michael Ortwerth at Michael.Ortwerth@fda.gov.

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Peter J. Pitts appointed associate FDA commissioner for external relations

FDA Commissioner Mark B. McClellan, M.D., Ph.D., recently named strategic communications and marketing professional Peter J. Pitts, the Agency's associate commissioner for external relations. According to an April 21 FDA press release, Pitts will supervise FDA's Office of Public Affairs, Office of the Ombudsman, Office of Special Health Issues, Office of Executive Secretariat, and Advisory Committee Oversight and Management Staff. Pitts responsibilities as associate commissioner include acting as the senior communications advisor to Dr. McClellan, providing executive level policy and program direction for the Agency's interactions, and overseeing information exchanges and liaison activities with FDA stakeholders.

Pitts last served as managing partner of the strategic marketing firm Wired World. His writing credits include a book about successful leadership based on strategic vision and ethical practice entitled Become Strategic or Die.

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HHS announces call to action on oral health

The U.S. Department of Health and Human Services (HHS) has released a National Call to Action to Promote Oral Health. The goal of the program is to improve oral health and prevent disease for all Americans, especially children. U.S. Surgeon General Richard H. Carmona, M.D., M.P.H., F.A.C.S., announced the new plan during the 2003 National Oral Health Conference in Milwaukee, Wisconsin.

The new plan identifies the following action areas:

• Change the perceptions of oral health care;
• Overcome barriers to care by replicating effective programs and proven efforts;
• Build the science base and accelerate science transfer;
• Increase oral health workforce diversity, capacity, and flexibility; and 
• Increase collaboration

According to an April 29 HHS press release, the new National Call to Action will solicit help from healthcare providers, communities, and policy makers in order to build on the findings from the 2000 Oral Health in America: A Report of the Surgeon General the oral objectives of Healthy People 2010.

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FDA holds first stakeholder meeting on proposed dietary supplement GMPs

FDA held the first of several stakeholder meetings April 29 in College Park, Maryland, to brief interested parties and to take questions on the Agency’s proposed rule for dietary supplement Good Manufacturing Practices (GMPs) (see March 7 XNL). Lab operations and methods validation for ingredient testing drew the bulk of questions from the attendees of the meeting.

Future meetings on the subject are scheduled for May 4 in Seacaucus, New Jersey, May 6 in Oakland, California, and via satellite broadcast May 9. For technical details for the satellite meeting, click here. FDA's deadline for comments on the proposed GMP rule are due by June 11.

 CHPA contacts: Fred Razzaghi and David Spangler

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CHPA staff travel inside the Beltway and beyond

CHPA President Linda Suydam was in California April 22 to attend the USCF School of Pharmacy Dean's Board of Advisors spring meeting at the school's new Mission Bay campus...

Linda Suydam and Ted Peterson, vice president for corporate development, attended the National Association of Chain Drug Stores annual meeting April 26-30 in Palm Beach, Florida. During the meeting, Suydam and Peterson met with existing and prospective CHPA members, retail executives, inter-industry trade associations, trade press reporters, and potential service providers to CHPA...

Eve Bachrach, Senior Vice President, General Counsel and Secretary, and David Spangler, vice president-international and assistant general counsel, attended a reception April 28 in Washington, D.C. for the Campaign for Nursing's Future, sponsored by Johnson & Johnson in conjunction with national nursing organizations. U.S. Department of Health and Human Services Secretary Tommy Thompson and J&J President and Vice Chairman of the Board Jim Lenehan both spoke at the event...

David Spangler and Fred Razzaghi, director, technical affairs, were at FDA's first stakeholder meeting April 29 in College Park, Maryland, on the Agency's proposed rule on dietary supplement Good Manufacturing Practices (see related story)...

On May 1, Linda Suydam traveled from Florida to New York City to attend the Healthcare Businesswomen's Association's Woman of the Year luncheon honoring GlaxoSmithKline's Cathy Sohn (see March 7 XNL). Suydam was invited as a guest by GSK's Jack Ziegler, president, consumer healthcare. The event was attended by over 1,400 people...   

David Spangler visited with Dr. Yung Ok Kim of Korea's FDA May 2 in Washington, D.C., to discuss OTC regulation in the United States, with an emphasis on drug-cosmetics...

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Props 65 News to hold annual conference in Sacramento

"Proposition 65: Sorting Out the Conflicts" is the theme of Prop 65 News'  June 2 annual conference and seminars to be held at the Sacramento Convention Center in Sacramento, California. The program offers a variety of panelists representing the legal and environmental communities who will examine  such topics as how recent reforms have affected Prop 65, whether going to court or using alternative dispute resolutions works best, and what's in store for the future of Prop 65. Attendees may also choose between three seminar topics including one that will focus on the role that trade associations play in industry-wide settlements. CHPA members may take advantage of a group rate by indicating that you are a member of the Association on the meeting registration form. For more information on the event, contact Lana Beckett at 1-(800) 277-6765 or e-mail prop65@prop65news.com.

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USP cosponsors June analytical methods conference

The United States Pharmacopeial Convention, Inc. (USP), along with the American Chemical Society, the American Society for Testing and Materials, and the National Institutes of Standards and Technology, will conduct an open conference on analytical methods and other USP issues, June 1-4 in Philadelphia, Pennsylvania. The objective of the conference is to increase awareness and understanding of analytical challenges in the pharmaceutical industry. Plenary and interactive sessions will focus on topics such as heavy metals, process analytical technologies, and guidelines for submission of new monographs for excipients. For additional program information, visit www.usp.org/frameset.htm?http://www.usp.org/aboutusp/meetings/mtg10.htm.

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CDER launches pilot web site drug locator

FDA's Center for Drug Evaluation and Research (CDER) has developed a web site pilot project designed to provide one convenient location for Internet users to obtain accurate information about FDA-approved brand name and generic drugs. Referred to as Drugs@FDA, the new site is a searchable database that contains approval letters, labels, reviews, and other information pertinent to Rx and OTC drugs currently approved for sale in the United States as well as discontinued drugs. To try out this new information source, visit www.accessdata.fda.gov/scripts/cder/drugcat/.

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HHS celebrates 50th anniversary 

The U.S. Department of Health and Human Services (HHS) had its 50th birthday celebration April 30. Established in 1953 under then-President Dwight D. Eisenhower, HHS has grown substantially from its initial budget of $7 billion to a half-trillion dollars in annual spending. According to an HHS press release, the department administers more grant dollars than all other federal agencies combined. HHS currently employs 65,000 individuals and oversees 10 divisions, including FDA, the Agency that regulates products representing 25 cents of every dollar in U.S. consumer spending.  

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Tommy Thompson bids farewell to his chief of staff

U.S. Department of Health and Human Services Secretary Tommy Thompson recently announced that his long-time confidant and Chief of Staff Robert D. Wood is leaving the department to work in the private sector. Wood has served as an advisor to Thompson since 1994 when he was governor of Wisconsin. More information on Wood's departure is available in an April 30 HHS press release.

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FDA/Industry Summer Workshop
June 16, 2003
Sheraton Meadowlands
East Rutherford, New Jersey

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

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

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