Association News

CHPA supports Congressional effort to raise awareness about medication abuse

CHPA issued a news release July 26 applauding the U.S. House Government Reform Subcommittee on Criminal Justice, Drug Policy and Human Resources for convening a hearing to examine ways to address the problem of medicine abuse. During the hearing, a panel of expert speakers presented various viewpoints on both the scope of the problem and efforts underway to address the recent trend of medicine abuse among teens.

Among the panelists at the hearing was Stephen J. Pasierb, president and CEO, Partnership for a Drug-Free America, who highlighted CHPA’s most recent efforts to proactively address the abuse of OTC medicines. This national public awareness initiative—the Rx and OTC Medicine Abuse Education Campaign—is designed to build awareness about Rx and OTC medicine abuse through a comprehensive, multi-media communications effort that speaks directly to parents.

CHPA submitted a written statement to the subcommittee further describing the Association's efforts to combat medicine abuse and to seek support for H.R. 5280, the Dextromethorphan Distribution Act of 2006. Sponsored by U.S. Representatives Fred Upton (R-Mich.) and Rick Larsen (D-Wash.), the bipartisan bill seeks to cut off the supply of pure dextromethorphan to those individuals who are misusing it to get high or who intend to sell it as a street drug (See May 5 XNL).

CHPA contact: Elizabeth Assey | Back to the top


FDA/industry workshop attendees get an education on pharmaceutical quality systems

Last week, FDA and industry conducted its final educational workshop of the summer in Chicago, Illinois. Over 140 professionals attended the July 20 event to learn more about FDA's and industry's efforts to improve the quality of drug products.

Among the FDA speakers at the workshop were Scott MacIntire, director of the Agency's Chicago district, and Joseph Famulare, acting director, Office of Compliance, Center for Drug Evaluation and Research (CDER). MacIntire began his presentation by reminding the audience that FDA is responsible for regulating industries that add approximately $1 trillion worth of value to the economy. He then described some of the diverse responsibilities of the Agency's Office of Regulatory Affairs (ORA), noting that its mission is to protect consumers and enhance public health by maximizing compliance of FDA-regulated products and minimizing risk associated with those products. In terms of the amount of resources required to realize this mission, MacIntire stated that drugs take up to 20 percent of full-time equivalents (FTEs), while foods take up to 55 percent.

According to MacIntire, a significant amount of ORA’s attention is paid to imports. Based on FDA data, the growth of imported FDA-regulated entries has more than tripled to 14 million. He noted that drugs compose only two percent of imports, while devices come in with 20 percent, and foods take the lion share with 65 percent. Correspondingly, the size of the international markets has increased to 225 countries exporting FDA-regulated goods.

During his remarks, Famulare, one of the leaders of FDA’s Good Manufacturing Practices (GMP) initiative, focused on CDER’s risk-based model to "assure public health by strategically monitoring drug product quality." Famulare explained how quality by design is embedded in the current GMP’s and that the path forward is to operationalize the desired state by using quality by design and the design-space concept adoption by FDA and industry as well as quality system approach adoption by FDA and industry. For a copy of Famulare's presentation, click here.

Industry speakers at the meeting included Claudio Pincus, president, Quantic Group, Ltd., who made a compelling case for an effective quality system by stating that GMPs are best viewed from a systems perspective and that the benefits of the whole exceed the sum of the parts. He said that a system is a design of integrated components that can measure the performance of the whole and can predictably and consistently detect and correct deficiencies. Systems thinking is a framework for seeing interrelationships rather than things, for seeing patterns of change rather than static snapshots.

CHPA contact: Fred Razzaghi | Back to the top


Cargill's HT Fish elected to CHPA's Board of Directors

HT Fish, president, Cargill Health and Food Technologies, was elected to serve on CHPA’s Board of Directors during the Association’s June 29 board meeting. Fish will fill the board seat previously held by Ted Ziemann, who retired from Cargill in June.

Fish joined Cargill in the fall of 2004 as business development manager within the company's Strategy & Business Development area. He was named to his present position on June 1 of this year. Prior to Cargill, Fish held strategy and operating positions at Ingenix (a division of UnitedHealth Group), and was with McKinsey & Company from 1995-2001, where he served a variety of industrial and healthcare clients across a broad spectrum of strategic, operational, and organizational issues. He holds a degree in chemistry from the University of Colorado, and received a doctorate in inorganic chemistry from Stanford University.

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CHPA members participate in joint industry conference on unsaleables

CHPA members were among the many who traveled to Charleston, South Carolina, July 12-14, to participate in the 2006 Joint Industry Unsaleables Management Conference. CHPA cosponsored the event, along with the Food Marketing Institute (FMI), the Grocery Manufacturers Association (GMA), and the National Association of Chain Drug Stores.

CHPA Active member companies in attendance at the conference included representatives from Bayer HealthCare LLC; Colgate-Palmolive Company; Johnson & Johnson; The Mentholatum Company; Novartis Consumer Health, Inc.; Pfizer Inc; The Procter & Gamble Company; Schering-Plough HealthCare Products, Inc.; and Wyeth Consumer Healthcare. CHPA Associate members that were sponsors and exhibitors at the conference included Active International, Inc.; Carolina Logistics Services; and ICON International Inc.

Unsaleables attendees had ample time to network during the exhibitor-sponsored breaks.

During the conference, GMA and FMI announced the 2006 Unsaleables Innovation Award winners, which are exemplary companies that work across industries to reduce the incidence of unsaleables. This year's awards went to two pairs of companies: H-E-B and Carolina Supply Chain Services (CSCS), a CLS company, and Heinz U.S. Consumer Products and GENCO Damage Research. Copies of all of the award entries are available online.

GMA’s Senior Director, Industry Affairs Karin Croft (third from right) poses with the winners of his year’s Unsaleables Innovation Awards.

Additional highlights of the conference included the release of the 2006 Unsaleables Benchmark Report and a presentation on the November 2005 report entitled Improving Unsaleables Management Business Practices—Joint Industry Recommendations.

Mark your calendars for next year's event

CHPA members should note that the 2007 Joint Industry Unsaleables Management Conference is scheduled for July 17-19 at The Ritz-Carlton in Lake Las Vegas, Nevada.

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CHPA on the Road

CHPA staff travel inside the Beltway and beyond

President Linda A. Suydam, D.P.A., represented the Association at the annual Alliance for Health Reform dinner July 24 which was held at the home of U.S. Senate Majority Leader Bill Frist (R-Tenn.). Also in attendance were Alliance Co-chair Senator Jay Rockefeller (D-W.Va.), and Senators Susan Collins (R-Maine) and Bill Nelson (D-Fla.), as well as House members Tom Allen (D-Maine) and Bart Gordon (D-Tenn.)…

President Linda A. Suydam, D.P.A., and Vice President of Communications and Strategic Initiatives Virginia Cox traveled to Orlando, Florida, July 25 to attend a portion of the annual conference of D.A.R.E. America. They met with D.A.R.E. President and Chief Executive Officer Charlie Parsons and other staff to discuss possible collaborations…

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Industry News

Federal Agency Update

FDA takes steps to improve its advisory committee process

FDA issued a news release July 24 announcing that the Agency is taking measures to help make its advisory committee process more transparent and effective and to help bolster public confidence in the overall integrity of the process.

According to FDA, the Agency plans to take the following steps over the next few months:

• Issue a guidance to more clearly identify the conditions under which conflict-of-interest waivers are granted;

• Issue a guidance specifying when conflict-of-interest waivers will be disclosed to the public and what information will be made available;

• Issue a guidance specifying when briefing materials used at advisory committee meetings will be made publicly available;

• Provide greater public dissemination of advisory committee schedules through increased mailings, electronic notifications, and postings on FDA's web site; and

• Implement a more streamlined approach to the appointment of members to the Agency's drug-related advisory committees.

FDA also reiterated its May 5 announcement that the Agency's Center for Drug Evaluation and Research is conducting an internal assessment of its advisory committees to establish best practices surrounding the process (See May 19 XNL).

CHPA contact: Dr. Lorna Totman | Back to the top


NDAC meets in September

FDA issued a notice in the July 25 Federal Register announcing that its Nonprescription Drugs Advisory Committee (NDAC) will meet September 25 from 8:00 a.m. to 5:00 p.m. at the Hilton Hotel Gaithersburg in Gaithersburg, Maryland. According to FDA, the purpose of the public meeting is for NDAC to consider issues related to the analysis and interpretation of consumer behavior studies conducted to support the marketing of OTC medicines.

The Agency notes that background material for the meeting will be made available on the NDAC docket web site no later than September 24. Written submissions and requests to make oral presentations should be sent to Darrell Lyons at FDA's Center for Drug Evaluation and Research by September 11.

CHPA contact: Dr. Lorna Totman| Back to the top

FDA launches consumer education program on the safe use of OTCs
 
FDA's Center for Drug Evaluation and Research (CDER), in cooperation with the National Council on Patient Information and Education (NCPIE) and Maryland’s Montgomery County Public Schools, recently launched an online educational program about the safe and effective use of OTC medicines. Entitled “Medicines in My Home,” this interactive web site includes a “Teachers Room,” featuring a PowerPoint presentation, pre- and post-test, in-class lesson materials, and activities for use in the home with family members. "Medicines in My Home" emphasizes the importance of the Drug Facts label and instructs children to seek adults permission before using a medication.

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OTC Issues
New OTC sunscreen product approved by FDA

FDA issued a news release July 24 announcing that the Agency has approved Anthelios SX for sale as an OTC sunscreen for the prevention of sunburn and for protection against ultraviolet A and B rays. Manufactured by L'Oréal SA and to be distributed by LaRoche-Posay, the product has a sun protection factor (SPF) of 15.

According to FDA, Anthelios SX contains a combination of three active ingredients, one of which is a new molecular entity called ecamsule. Ecamsule has not yet been marketed in the United States, but has been sold as Mexoryl SX in Europe and Canada since 1993. The remaining active ingredients, avobenzone and octocrylene, are generally recognized as safe and effective under the OTC sunscreen monograph.

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FDA calls for information on OTC sunscreen ingredient

As part of its ongoing OTC Review, FDA published a notice in the July 26 Federal Register calling for safety and effectiveness information for diethylhexyl butamido triazone, up to three percent, as a sunscreen single active ingredient and in combination with other sunscreen active ingredients. The Agency states that it has reviewed a time and extent application for this condition and found that it is eligible for consideration in the OTC drug monograph system. Persons wishing to submit safety and effectiveness data must do so by October 24. FDA notes that it will review all information it receives on the condition to determine whether it can be generally recognized as safe and effective (GRAS/E) for its intended OTC use.

CHPA contacts: David Spangler and Dr. Lorna Totman | Back to the top


IOM releases report on preventing medication errors

The Institute of Medicine of the National Academies (IOM) issued a press release July 20 announcing that it has published a new report entitled Preventing Medication Errors. Developed by the IOM Committee on Identifying and Preventing Medication Errors, the report offers strategies to reduce drug-related mistakes. According to the committee, mistakes involving Rx drugs, OTC medicines, and dietary supplements negatively impact 1.5 million people each year. The committee notes that there is insufficient data to accurately determine all of the costs associated with these errors, but estimates that drug-related injuries will result in at least $3.5 billion in extra medical expenses in 2006.

The IOM report contains a series of actions for patients, healthcare organizations, government agencies, and pharmaceutical companies to take to improve communication between healthcare professionals and patients, as well as measures patients should take to protect themselves. It also recommends the development of new, consumer-friendly drug information resources, calls for all prescriptions to be written electronically by 2010, and suggests ways to improve the naming, labeling, and packaging of drugs to help reduce consumer confusion and further prevent errors.

To help with the development of new drug information resources, the report recommends that FDA work with other groups to standardize medication leaflets to ensure they are consumer-friendly. The committee calls on the National Library of Medicine (NLM) to be the chief agency in charge of online health resources for consumers, which would include developing a new centralized web site and evaluating other online health information. The committee also recommends that FDA, NLM, and the Centers for Medicare and Medicaid oversee and fund the development of a national network of telephone help lines to provide consumers with additional medication information and enable them to report drug-related mistakes.

With respect to electronic drug prescriptions, the report states that all healthcare providers and pharmacies should have plans in place by 2008 and use e-prescribing systems by 2010. According to the committee, the Agency for Healthcare Research and Quality (AHRQ) should take the lead in overseeing the IT systems involved with ordering, administering, and monitoring drugs.

Finally, the report urges FDA and AHRQ to collaborate with the U.S. Pharmacopeia, the Institute for Safe Medication Practices, and other appropriate organizations to develop a plan to address any problems associated with drug naming, labeling, and packaging by 2007. The committee also recommends that drug-naming terms should be standardized as much as possible, and all pharmaceutical companies should be required to use the standardized terms.

FDA says that many of IOM's recommendations already are underway

FDA issued a statement July 20 supporting the release of the new IOM report. According to the Agency, many of the recommendations on medication error prevention, patient education, and label comprehension included in the report already are underway. In explanation, the Agency provided a detailed list of some of its more recent activities including partnering with the Institute on Safe Medication Practices to refine its review of look-alike, sound-alike drug names, and requiring bar codes on thousands of drug labels.

The Agency further stated that it is committed to working with other government agencies, professional and patient groups, and industry to continue to reduce the incidence of medication errors.

Pre-publication copies of Preventing Medication Errors are available online.

CHPA contacts: David Spangler and Dr. Lorna Totman | Back to the top


In Brief

Former FDA Director Audrey Sheppard to lead NWHRC

The National Women's Health Resource Center (NWHRC) issued a press release July 17 announcing that Audrey Sheppard, former director of FDA's Office of Women's Health, has been named president and chief executive officer of the organization. During her tenure at FDA, Sheppard played a key role in the creation of the Agency's "Women's Health: Take Time to Care" campaign on safe medication use. After her departure from FDA, she served as a women's health consultant to national corporations and not-for-profit organizations. Currently, she is the president of the Sewall-Belmont House and Museum, which is the nation's leading women's historical museum, located in Washington, D.C.

In additional NWHRC news, the organization announced that Elizabeth Battaglino Cahill, RN, director of marketing and consumer affairs, has been promoted to executive vice president.

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FTC's Lee Peeler named NARC president, CBBB executive vice president

C. Lee Peeler, deputy director of the Bureau of Consumer Protection, U.S. Federal Trade Commission (FTC), has been named president and chief executive officer of the National Advertising Review Council (NARC) and executive vice president, national advertising self-regulation, of the Council of Better Business Bureaus, Inc. (CBBB). Peeler joined the FTC in 1973, where he served as associate director of the Bureau of Consumer Protection's Division of Advertising Practices for 16 years before being named deputy director of the Bureau of Consumer Protection in 2001. According to a July 24 press release, Peeler, who will succeed James R. Guthrie, will assume his duties at NARC and CBBB September 11.

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IVT hosts conference on RFID technology

The Institute of Validation Technology (IVT) is holding a conference August 22-25 in San Francisco, California, on radio frequency identification (RFID) technology within healthcare and pharmaceuticals. The event features expert speakers that will cover such topics as the most reliable approach to traceablility for pharmaceuticals, protecting the pharmaceutical supply chain, consumer safety and brand security, and applying packaging technologies in anti-counterfeiting and product traceability initiatives. Additional information on the conference is available online.

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