House approves increase in funding for OTC drug programs at FDA

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European Parliament votes on pharmaceutical legislation

The European Parliament voted December 17 on proposed amendments in the EU’s pharmaceutical legislation package (see October 30 XNL). Of particular interest to the OTC industry, the legislation includes a compromise package which provides for one year of data exclusivity for Rx-to-OTC switches and one year of data exclusivity for new indications for well-established substances.

“This is an important day for the European self-care industry. Through the new data exclusivity provisions, incentives have been put in place to invest in new self-medication medicines,” declared Dr. Hubertus Cranz, director-general, The Association of the European Self-Medication Industry. “Unfortunately, the compromise allows only one year instead of three years as proposed by the European Parliament and will therefore not maximize the innovative capability of the self-care industry. However, accepting both principles shows that the political institutions have understood the importance of the issue and were prepared to address it.”

The data exclusivity provisions are part of a comprehensive revision of the pharmaceutical legislation which was complemented by specific legislation on traditional herbal medicines. The European Parliament’s action adopted amendments to the common position which were part of an overall compromise package with the Council of Ministers. The new legislation covers a number of issues of interest to manufacturers of nonprescription medicines, including:

• The extension of the optional use of the centralized procedure to innovative nonprescription medicines,

• Improvements to the mutual recognition system by better defining reasons for rejecting a mutual recognition request and by establishing a new committee for herbal medicinal products at the European Medicines Evaluation Agency, and

• A clarification that all nonprescription medicines may be publicly advertised.

From here, the council will formally agree on the amendments adopted by the European Parliament and the final adoption of the legislative package is expected in early 2004.

At press time, the complete text of the pharmaceutical legislation package was not available online.

CHPA contact: David Spangler

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CHPA urges USTR to focus on OTC distribution restrictions in Japan 

CHPA filed comments December 12 for the U.S. Trade Representative’s (USTR's) annual National Trade Estimate Report (NTE) on Foreign Trade Barriers. CHPA urged USTR to draw attention to OTC medicine distribution restrictions in Japan in this year’s NTE and to encourage Japan to address this indirect barrier to market entry.

When combined with the ban on comparative advertising in Japan, limiting the sale of OTC medicines to pharmacies and drugstores reinforces the status quo in that market and dramatically reduces the odds of success for American firms seeking to introduce proven safe and effective OTC medicines in Japan.

CHPA’s comments were intended to reinforce and expand on suggestions from Japan’s advisory Council on Regulatory Reform and a cabinet-level regulatory reform agenda, which have called for consideration of allowing at least some OTC medicines to be sold in a wider range of retail outlets.

Meanwhile, a study panel to Japan’s Ministry of Health, Labour & Welfare December 18 recommended that roughly 350 OTC medicines be allowed to be sold outside of pharmacies in Japan. MHLW is expected to act on the recommendation in the fairly near term, although it has not been determined whether a change would require an amendment to Japan’s Pharmaceutical Affairs Law (less likely), or if it can be accomplished through a transfer of the medicines to “quasi-drug” status (more likely).

A number of digestive products, laxatives, gargles, topical cough/cold products, skin protectants, antiseptics, and vitamin or calcium products classified as drugs are expected to be included among the 350.

CHPA contact: David Spangler

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Social and networking opportunities begin with a Capitol AEC

Preparations for the Annual Executive Conference (AEC) set for March 17-19, 2004, at the Grand Hyatt, Washington, D.C., are coming together nicely. In addition to a business program with a strong government and policy emphasis, a number of networking opportunities also will be available. For example, attendees who become parched during the registration process on March 17 should make a special point of quenching their thirst at the “It All Starts Here” hospitality lounge sponsored by Prevention. Later that evening, ACNielsen will host a “Celtic Celebration,” complete with food and entertainment including a traditional Irish sing-along presented by Seamus Kennedy and a bagpipe and drum group joined by dancers from the Broesler School of Irish Dance.

March 18 includes a reception hosted by Grey Worldwide and a networking dinner, both at the National Museum of Women in the Arts. The evening will conclude with entertainment provided by the Capitol Steps who will parody the most current and not-so politically correct headlines of the day. Seating at the dinner will be assigned and all conference attendees are asked to attend.

Take advantage of these social opportunities at the conference to connect with industry colleagues and key business contacts.  For more information on the 2004 Annual Executive Conference, visit the Members Only section of CHPA’s web site, or contact Kass Kassouf or Maria Sarabia. If you have not registered for the Members Only section of www.chpa-info.org, contact Susan DiBartolo.

CHPA contact: David Spangler

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CHPA Holiday Schedule

CHPA's staff will observe the following schedule
during the upcoming holidays:

December 24 (Christmas Eve): Open until 12:00 p.m.

December 25 - January 2: Closed

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FDA publishes compliance aids for the Bioterrorism Act

FDA recently issued three documents to provide assistance to industry on the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act). The first, released in the December 15 Federal Register, is a compliance policy guide entitled “Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.” The guidance explains among other things, the Agency’s implementing regulations, which became effective December 12, that require prior notice for all food imported or offered for import (including dietary supplements) into the United States.

The second document, announced in the December 16 Federal Register, is a guidance called “Prior Notice of Imported Food, Questions and Answers.” This guidance responds to a variety of questions the Agency has received concerning the implementation of the food importation regulations. 

The third document, made available in the December 19 Federal Register, is a compliance guide for FDA staff that addresses enforcement of the provision of the Bioterrorism Act that requires registration with FDA for all domestic and foreign facilities that manufacture, process, pack, or hold food (including dietary supplements) for human or animal consumption. 

CHPA contact: Steve Mister

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NIH issues five-year draft strategic plan for ODS

The National Institutes of Health (NIH) released a draft strategic plan December 17 for its Office of Dietary Supplements (ODS). The draft plan, entitled “Promoting Quality Science in Supplement Research, Education, and Communication,” was prepared based on discussions at a May 8-9 strategic planning meeting (see May 16 XNL), comments received since that time, and extensive discussions with ODS senior staff.

ODS points out to readers reviewing the new draft plan that similar to its 1998 strategic plan, the five goals mentioned are basically the same, only slightly reworded. Unlike the 1998 version, however, the “objectives” have been replaced by “initiatives” that are generic rather than disease or disorder specific.

ODS has provided a limited timeframe to review and comment on this document. All suggestions and recommendations should be e-mailed to ODSplan@od.nih.gov by January 5, 2004.

CHPA contact: Doug Bierer

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FDA revises advisory committee hotline

FDA announced in the December 18 Federal Register that it has updated the advisory committee information hotline. The hotline provides the public with the most current information concerning advisory committee meetings, guidance for making oral presentations, and procedures for obtaining meeting transcripts. The hotline can be accessed by dialing either (800) 741-8138 or (301) 443-0572. Each committee is assigned a 10-digit access number that also must be entered. Following are the access numbers for advisory committees of special interest to the industry:

CHPA contact: Dr. Lorna Totman

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Task force on drug counterfeiting submits recommendations to FDA

The Product Safety Task Force (PSTF), an industry-wide coalition organized by Healthcare Distribution Management Association (HDMA), recently issued its report and recommendations on FDA's October 2003 Anti-Counterfeiting Interim Report.

In its report, the PSTF strongly endorsed a multi-pronged strategy, including use of technological, regulatory, enforcement and educational options. The PSTF said that it believes that industry is in the best position to determine optimal individual and collaborative responses to counterfeiting, as the products, vulnerabilities, and solutions are best known by those creating, delivering, and administering the products.

The PSTF also recommended allowing the industry to continue to operate in its current manner, allowing market conditions to continue to drive such issues as market structure and provision of packaging format. PSTF said that it did not recommend any mandated change in the distribution system that would require direct shipping of product from manufacturer to pharmacy, nor a requirement for unit-of-use packaging.

PSTF stated that it did not support  the creation and enforcement of stiffer penalties for counterfeiting, as well as tighter licensing requirements for all registered to do business in the healthcare supply industry. However, the task force did recommend, on an as-needed basis, the review and tightening of due diligence procedures for all healthcare supply chain partners in order to help prevent and eliminate unscrupulous parties from participating in the industry.

Finally,  PSTF suggested that FDA encourage industry to develop and implement track and trace functionality as a key anti-counterfeiting strategy by endorsing any industry-coalition developed timeline for migration to this technology.

CHPA contact: Fred Razzazghi

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CHPA staff travel inside the Beltway and beyond

Vice President for Corporate Development Ted Peterson was in Michigan December 22  to meet with staff executives from the Chain Drug Merchandising Association (CDMA) to discuss the OTC flex spending account initiative and CDMA's communications to and merchandising opportunities with their retailer members...

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WSMI releases Spanish-language version of its popular self-medication handbook

Earlier this month, the World Self-Medication Industry (WSMI), with help from the Latin American Self-Medication Industry (ILAR), released a Spanish-language version of its self-medication handbook called Cόmo Crear un Marco para el Consumidor que Cuida de su Saldud. Translated directly from the English-language version, Creating a Framework for the Self-Care Consumer, the Spanish version provides a detailed explanation of the basis for self-medication and describes several policy approaches for the self-medication framework. To obtain a copy of Cόmo Crear un Marco para el Consumidor que Cuida de su Saldud, e-mail ILAR’s Héctor Bolaños or visit www.wsmi.org.

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Conference Board workshop to explain how to extend company brands to employees

The Conference Board will present its “Extending Your Brand to Employees" conference February 26-27, 2004, in Chicago, Illinois. The two-day event will teach senior management how to help employees identify with their respective company brand with the ultimate goal of delivering a consistent brand promise to customers. The conference will provide a forum for marketing, communications, brand, and HR professionals with special attention given to how these disciplines can collaborate more effectively. Researchers and practitioners will be on hand to help attendees develop and implement approaches. Complete details are available at www.conference-board.org/conferences/conference.cfm?id=596.

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Asia-Pacific health expo to be held in Shanghai

For Health USA is sponsoring the first Asia-Pacific Natural Health Products Expo in Shaghai, China, April 23-25, 2004. Government officials from health-related industries from the United States and China will be featured speakers at the forum. Topics to be addressed include cooperation between the United States and China and its significance on the world's health, the regulations on imported health products into the United States, and new technology and management in U.S. health and related industries. For more information, or to register for the expo, click here.

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2004 Annual Executive Conference
March 17-19, 2004 
Grand Hyatt Washington
Washington Center, 1000 H Street, NW
Washington, D.C.

2004 Business Exchange
September 23, 2004
Hilton East Brunswick
East Brunswick, NJ

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