Association News

Cough medicine makers applaud age restrictions on sales of medicines containing dextromethorphan

Retail effort is key component to overall educational initiatives, says CHPA

CHPA issued a press release May 17 applauding recent actions taken by many major retailers to prevent children under the age of 18 from purchasing OTC cough medicines that contain dextromethorphan. Recent studies have spotlighted cough medicine abuse as an alarming trend among young people who intentionally take large amounts of cough medicine to get "high" from the active ingredient dextromethorphan. CHPA has been working with the retail community to address this abuse and has been supportive of all retail efforts to impose age restrictions.

"While education is the most effective tool we have in preventing substance abuse, we feel these age restrictions will reinforce these efforts and help parents keep their kids safe," said Linda A. Suydam, D.P.A., president of CHPA. "As the leading makers of these trusted, over-the-counter medicines, we also are working diligently to educate parents and community leaders about this problem and provide them with resources to combat this growing trend."

Last week, CHPA and its members launched its comprehensive, online Five Moms Campaign to drive parents to action: to educate themselves on substance abuse with medicines, to talk with their children about the risks of such abuse, and to spread the word to other parents (See related story). Additionally, in the next several weeks, the leading makers of cough medicines will be launching a print advertisement campaign aimed at increasing awareness about the dangers of cough medicine abuse.

"When used correctly, dextromethorphan-containing medicines have a 50-year history of being safe and effective," Suydam added. "We are hopeful that our educational efforts to alert parents and communities to the recent reports of cough medicine abuse, combined with the implementation of age restrictions on these medicines, will ensure our medicines are being used in a way that continues to benefit families."

All of CHPA’s initiatives to stop cough medicine abuse by teens are summarized online.

CHPA contact: Elizabeth Funderburk | Back to the top


Five moms take a stand against cough medicine abuse

Five moms, from different walks of life and from all across the country, launched a grassroots campaign May 9 to stop the dangerous trend of teens abusing cough medicines to get high. The campaign, developed by CHPA, is designed to alert parents to a growing problem that most don’t even know exists.

"Substance-abuse experts agree that education is the key to preventing—and stopping—such abuse," said CHPA President Linda A. Suydam, D.P.A. "Parents have trusted us with the health of their families for more than 50 years. Now it’s our turn to alert them to a problem that every family should know about."

At the heart of the Five Moms Campaign are five exceptional women, each dedicated to spreading the word about the dangers of cough medicine abuse across the country and in her own community. CHPA conducted a national search to find the Five Moms. They are:

• Julie Berman, a pediatric nurse practitioner from Massachusetts

• Blaise Brooks, an accountant from California

• Christy Crandell, the California mother of a former cough-medicine abuser

• Becky Dyer, a D.A.R.E. officer and deputy sheriff from Kansas

• Hilda Morales, an educator from Texas

From left: CHPA's Virginia Cox with four of the Five Moms Becky Dyer, Blaise Brooks, Julie Berman, and Hilda Morales.

Campaign serves as a wake-up call to parents

Recent studies have spotlighted cough medicine abuse as an alarming trend among young people, who intentionally take large amounts of cough medicine to get a "high" from the active ingredient dextromethorphan. Data collected by the Partnership for a Drug-Free America show that one in 10, or 2.4 million young people, reports having abused dextromethorphan-containing medicines to get high.

The Five Moms Campaign will use the very same tactics medicine abusers are using: spreading and promoting information on the Internet. The Five Moms’ goal is to get the word out to as many parents as possible that cough medicine abuse is happening in their homes, and that the Internet is a driving force.

The centerpiece of the campaign is www.FiveMoms.com, a web site where parents can find information about cough medicine abuse, read blog entries from the Five Moms and occasional special "guest" moms, and link to sites that have additional resources. FiveMoms.com is a place parents can go to learn how to spot the warning signs, as well as what to do if they suspect their child is abusing.

In conjunction with the campaign launch, the Five Moms released a short viral video via e-mail to their friends and family, with the goal of the video reaching a million moms by the end of the year.

Another feature of the campaign is a special community on www.gather.com, a social networking site for parents, where they can share their perspectives on cough medicine abuse and benefit from the experiences of others.

We joined together to protect our kids and to make parents stronger," said Five Mom Hilda Morales. "If we do this right, every parent in America will know about this problem."

Trend spreading through online communities

The Internet is heavily populated with web sites and online communities, including MySpace, YouTube, LiveJournal, and Facebook, that feature detailed instructions on how to abuse cough medicine, as well as videos of kids experiencing the "high." Some web sites even sell the raw, unfinished form of dextromethorphan, which can be deadly to anyone with a credit card and a shipping address.

"The people who promote cough medicine abuse online are Internet predators, plain and simple," said Five Mom and Deputy Sheriff Becky Dyer. "The teenagers who glorify this abuse on the Internet have no idea what danger they’re putting themselves and others in. And the people selling raw dextromethorphan to our kids just don’t care."

The Five Moms Campaign is part of a long-term, multi-media effort by CHPA to educate parents and teens about cough medicine abuse. CHPA has partnered with the Partnership for a Drug-Free America on public service announcements and bilingual educational materials, and the Community Anti-Drug Coalitions of America on a toolkit for community leaders. CHPA also is working with D.A.R.E. America to incorporate information about cough medicine abuse into its school curricula.

"Our member companies have worked tirelessly to educate parents about the potential for abuse," said Suydam. "The Five Moms Campaign takes this effort to an entirely new level."

Five Moms make national news

Just a few days following the launch of the Five Moms Campaign, CHPA Vice President, Communications & Strategic Initiatives Virginia Cox joined Julie Berman, Blaise Brooks, Becky Dyer, and Hilda Morales for the May 12 morning broadcast of FOX News' FOX & Friends. The segment, which aired portions of the campaign's viral video, was arranged to further promote this important grassroots effort.

Prior to their interview with FOX & Friends, some of the Five Moms pose outside of the FOX News studio in New York.

CHPA contacts: Virginia Cox and Elizabeth Funderburk | Back to the top


Ways to increase OTC access explored at 2007 RSC
 

CHPA’s Regulatory and Scientific Conference (RSC), held May 10-11 in Washington, D.C., marked the 75th scientific conference convened by the association. Over 160 individuals attended the event which focused on ways to enhance consumer access to nonprescription medicines in the United States. Outgoing CHPA Scientific Affairs Committee (SAC) Chair Edwin L. Hemwall, Ph.D., vice president, global regulatory and scientific affairs, Johnson & Johnson • Merck Consumer Pharmaceuticals Co., shared presiding duties with new SAC Chair Barbara A. Kochanowski, Ph.D., director, product safety and regulatory affairs, global personal health, The Procter & Gamble Company. 

There is no such thing as an average consumer, says Rand

The RSC provided varied opportunities, including case studies from non-U.S. countries, to explore alternative distribution options for nonprescription medicines, as well as the positions of various stakeholders. The stage was set by keynoter John Rand, director of retail insights, Management Ventures, Inc., who described a future of constant change in the retail marketplace. As consumers demand ever-different products and retailers begin to recognize that there is no “average consumer,” he said, the non-standardized retail site will be more successful. Rand asserted that manufacturers will need to develop products specifically for niche markets as defined by retailers.

Mann and Eberwein present switch case studies from overseas

Background on the approvals and marketing experiences for nonprescription products distributed under pharmacy-only restrictions in other countries was provided by two experts with first-hand experience. Stephen Mann, M.D., president, Mann Healthcare Ltd., told the story of the Zocor Heart-Pro^® (simvastatin) switch to nonprescription status in the United Kingdom, which entailed an extensive campaign to educate the public about cardiovascular health. In what Mann called a bold regulatory move based on sound clinical evidence to address a major public health concern, the decision to make a nonprescription statin available for primary prevention of cardiovascular disease in a moderate risk population offers a new paradigm in self-care which consumers have been slow to adopt, partly because of the “pharmacist barrier.” Mann emphasized, however, that the approval of an OTC statin set a precedent for future switch approvals as preventive medication. Another switch case study was presented by Dr. Bernd Eberwein, executive director, German Medicines Manufacturers’ Association, and a member of the German Expert Committee on Prescriptions. Eberwein described the basis for the first approval in the world of a nonprescription triptan for treating migraine headache, including the very important determination that migraine symptoms can be correctly diagnosed by consumers and the subsequent successful product introduction in April 2006.

Stephen Mann tells RSC attendees that the prescription-to-nonprescription switch of simvastatin in the United Kingdom presents a new paradigm in self-care.

Appleby shares the pharmacists' viewpoint on drug distribution

As the RSC focus turned to the current drug distribution in the United States and speculations about future options, conference attendees heard the pharmacists’ perspective from James C. Appleby, chief operating officer and senior vice president, business strategy & operations, American Pharmacists Association (APhA). He affirmed that pharmacists see value in having a class of nonprescription products available only behind the counter and that APhA supports restructuring the drug classification system and drug approval process beyond the current Rx and OTC classes. While contending that the existence of a “pharmacy-only” status in the United States could increase consumer access to valuable medicines, Appleby voiced his agreement that decisions about drug distribution must be driven by considerations of what is best for consumers.

Lutter and Hutt give two very different opinions on third class

Randall Lutter, Ph.D., acting deputy commissioner for policy, FDA, provided insight into current explorations within the agency of a “behind-the-counter” (BTC) class of OTCs. The goals that he proposed would be helped by a so-called “third class” are (1) increasing access to useful medicines, (2) providing another mechanism for managing risk, and (3) decreasing costs. He attributed the support from the pharmacist community as being another reason FDA is exploring another class of drug distribution. Citing market trends to empower consumers and the availability of supportive technology, Lutter declared this the “right time” for FDA to be considering changes in the U.S. OTC drug distribution system, adding that the agency would be providing more information on the matter “within months rather than years.”   Peter Barton Hutt, senior counsel, Covington & Burling LLP, on the other hand, argued that it is time to declare the regulatory constructs of “Rx,” “OTC,” and “third class” officially dead. He called for a new paradigm, a continuum of regulatory options, which in his opinion would not require new laws or regulations but would instead call for FDA and the manufacturers working together. Hutt called on RSC attendees to break down barriers to increased consumer access to appropriate medicines and to talk instead about public health objectives.

Panelists examine factors that impact consumer access to OTCs

An RSC panel session on “Understanding Consumer OTC Access,” moderated by Susan Lavine Coleman, president, NCI Consulting, examined certain healthcare and OTC drug distribution situations and how they affect consumer decisions to use products. Tine Hansen-Turton, executive director, Convenient Care Association, spoke about convenient, limited-service healthcare clinics within retail stores providing opportunities for increased consumer education about OTCs as well as more customer visits and increased retail sales. Stephen C. Johnson, executive vice president and general manager, Healthcare Solutions Group, Information Resources, Inc., presented the availability of Prilosec OTC (omeprazole) as a case study of expanded access resulting in greater consumer use of a medicine and contrasted it with the decrease in consumer purchases of pseudoephedrine products once they were restricted to behind the pharmacy counter. He called on retailers and manufacturers to work together to maintain appropriate access to medicines to best serve consumers. Randy P. Juhl, Ph.D., vice chancellor and professor of pharmaceutical sciences, University of Pittsburgh, examined strategic options for a “pharmacist-facilitated” class of drugs. He said the greatest challenge to a pharmacist-facilitated class of drugs is balancing the public health benefit with affordability, as pharmacists’ services will most certainly add cost.

Professor Eric Brass from UCLA imparts his thoughts on some of the many issues that must be carefully considered before a new restricted class of nonprescription medicines could ever be established.

Brass warns pharmacy-only status may not improve OTC access

In summarizing the messages from the conference, Eric P. Brass, M.D., Ph.D., professor of medicine, Geffen School of Medicine at University of California-Los Angeles (UCLA), and director, Harbor-UCLA Center for Clinical Pharmacology, noted careful consideration is needed about what problems are thought likely to be solved with a new restricted class of pharmacy-only, BTC nonprescription drugs in the United States. He opined that BTC status may not improve access to products if it is viewed by advisory committees and FDA as “safer” and becomes the default choice, resulting in fewer less-restricted OTC products being made available. Brass pointed out that the potential impact on costs to consumers of a more-restricted class of OTC products is an important unknown and cautioned that the potential impact on consumer access and health outcomes needs to be defined and validated.

FDA reports on current activities and future challenges

FDA panelists from left: Leah Christl, Andrea Leonard-Segal, and
Susan Johnson

An update from FDA's Office of Nonprescription Products (ONP) was a conference highlight. Leah Christl, Ph.D., chief, project management staff, Division of Nonprescription Clinical Evaluation (DNCE), and acting associate director for regulatory affairs, ONP, gave a detailed description of the current processes for collaborative reviews between DNCE and other divisions in FDA’s Center for Drug Evaluation and Research (CDER). She also explained the management processes for meetings with DNCE and other CDER staff. Andrea Leonard-Segal, M.D., director, DNCE, ONP, listed the DNCE staff and described their working relationship with the Division of Nonprescription Regulation Development (DNRD) staff in ONP. She spoke also about efforts to determine how to implement some of the recommendations from the September 2006 Nonprescription Drugs Advisory Committee meeting on consumer behavior studies and cited fruitful discussions with CHPA members on approaches to establishing a hierarchial approach for analysis of data from such studies. Susan Johnson, Ph.D., associate director, ONP, and acting division director, DNRD, informed conference attendees about various regulatory policies and activities within ONP, including the difficulty of predicting the timing for publication of various OTC drug regulations.

The conference also included an interactive workshop, led by Ira G. Asherman, Asherman Associates, Inc. (pictured here), on how to be a successful negotiator, whether with your co-workers or in negotiations between companies or between a company and FDA.

CHPA thanks RSC Planning Committee chair Leonard M. Baum, vice president and head, global regulatory affairs, Bayer HealthCare Consumer Care Division, and the other members of the planning committee for the excellent program.

CHPA contact: Dr. Marcia Howard | Back to the top


CHPA asks FDA to be flexible on labeling, dosing requirements for OTC convenience-size products

CHPA submitted comments to FDA May 7 concerning the agency's proposed rule on labeling requirements for OTC medicines. Issued December 12, 2006, the proposal seeks to amend the Drug Facts rule with a definition and alternate label options for convenience-size OTC drug products (See December 15, 2006, XNL).

CHPA told the agency that while it agrees, in principle, with most of the points outlined in the proposal, it does have concerns with certain aspects of the rule related to labeling and the maximum number of doses allowed for convenience-size OTCs.

On the issue of labeling, CHPA said that it supports FDA's decision to allow modifications to the Drug Facts format and wording for convenience-sizes. The association also agrees with the Agency's conclusion that the unique status of these products warrants flexibility in labeling, with a partially truncated label on the outer container. CHPA pointed out however, that there may be instances in which it is a practical impossibility to include the information inside the package.

With respect to dosing, FDA proposed that for products marketed with directions for both adults and children, "dose" should be defined as the maximum single serving based on the child's dose and that this proposed definition apply only to packages that contain one or two dosage units of an OTC drug. CHPA stated that while it agrees there should be a limitation to the amount of product contained in a convenience-size OTC medicine, there are certain instances in which these conditions may be too restrictive.

Specifically, CHPA asked FDA to:

1. Allow Drug Facts labeling information to be provided to consumers in narrative format with additional truncation permitted;

2. If truncated Drug Facts labeling in a narrative form is not permitted, allow labeling to be provided in a manner other than listing inside the convenience-size OTC product or an insert, such as tear-away sheets;

3. Expand the definition of "dose" to two adult doses for product categories where the potential child-size dose is meaningless for adult use;

4. Expand the number of doses allowed in convenience-size packages beyond two adult doses for certain categories by utilizing the criteria provided in the skin protectant final monograph;

5. Include topically applied OTC drug products in the final rule, but utilize the amount of available label space rather than "dose" as the criterion for permitting alternative Drug Facts labeling.

CHPA contact: Dr. Marcia Howard | Back to the top


CHPA/CRN seminar sheds light on adverse event reporting requirements

CHPA and the Council for Responsible Nutrition (CRN) are finalizing plans for the Adverse Event Reporting Seminar, scheduled for June 20 in Bethesda, Maryland. This one-day workshop will provide makers of dietary supplements and OTC medicines with a greater understanding of mandatory adverse event reporting, including the submission and maintenance of reports to comply with the recently enacted Dietary Supplement and Nonprescription Drug Consumer Protection Act.

The seminar will begin with the attorney's perspective as presented by Miriam Guggenheim, senior associate, Covington & Burling, who will address some of the key areas firms need to focus on under the law. Following Guggenheim's remarks, two panelists, including Steve Swantek, president & chief executive officer, PROSAR, will provide practical suggestions as to how companies can appropriately set up an adverse event reporting system. Also lending her expertise to the program is Heidi Horn, associate director, regulatory affairs, Perrigo Company, who will discuss some of the unique challenges faced by private label retailers. The seminar will conclude with representatives of FDA who have been invited to address the agency's rulemaking and guidance development process, explain plans to handle the incoming and existing adverse event report data, and discuss the auditing process.

Registration for the CHPA/CRN Adverse Event Reporting Seminar and the program brochure are available online. For registration questions, contact Katherine Bissell; for program questions, contact David Spangler.

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FDA and industry hold workshop on pharmaceutical quality systems

In the true spirit of collaboration, CHPA, allied industry associations, and FDA are again joining forces this summer to present a workshop on pharmaceutical quality systems. Scheduled for June 26–27 at the Hilton Parsippany in Parsippany, New Jersey, the workshop will focus on current issues and processes designed to increase compliance and improve the utilization of resources.

FDA's drug quality system program is well into its fifth year and the Quality Risk Management guidance is currently being implemented. During the workshop, attendees will hear from expert speakers on the implementation of risk management within a quality system, as well as participate in an interactive session on this topic. The workshop also will examine such issues as Process Analytical Technology and verification of processes, quality parameters and specifications, and the role of standards and quality by design.

____________________________

Pharmaceutical Quality Systems 2007

June 26–27, 2007

Hilton Parsippany

Parsippany, New Jersey
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Register now

Join experts from FDA, the OTC and Rx medicine industries, the generic drug business, and the excipients trade June 26–27 to hear the latest developments on FDA's quality initiatives for pharmaceuticals. Registration and hotel information, as well as the program details, may be accessed at www.chpa-info.org.

CHPA contact: Fred Razzaghi | Back to the top


There are still a few tables left for the 2007 Market Exchange

Tables are selling quickly for CHPA's 2007 Market Exchange, but there are still a few left. This important networking forum is scheduled for September 19–20 in New Brunswick, New Jersey. Make sure your company gets the exposure it deserves by registering for Market Exchange today at www.chpa-info.org.

Sponsors lend a helping hand 

CHPA is please to announce that the following members have signed on as sponsors for the Market Exchange:

The Emerson Group will again host a reception/dinner during the Market Exchange. This year, the event will be held Wednesday, September 19 from 5:30 to 8:30 p.m. at the Hyatt New Brunswick. The reception/dinner is open to all Market Exchange, committee meeting, and CHEC Board meeting attendees. Always a Market Exchange highlight, this casual event is an excellent opportunity to meet informally with company executives.

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MARS OTC/DTC will again be providing bottled water to Market Exchange attendees. CHPA is grateful to MARS for allowing participants to wet their whistles during this busy two-day event.

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Country Living and Good Housekeeping, both Hearst publications, will again memorialize the Market Exchange by providing a professional photographer to capture the event on film.

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New CHPA member WebMD magazine is sponsoring WiFi for the ballroom area. This service will allow attendees to maximize their productivity at Market Exchange by using down time to check e-mail or access the Internet.

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*Photo courtesy of Country Living and Good Housekeeping.

Get ready, get set...make appointments

CHPA Active members will soon be receiving user names and passwords for the Market Exchange interactive appointments web site. They will have until June 15 to identify those vendors with whom they wish to meet. Shortly after that date, table hosts will be given access to the site to find out which companies have requested a meeting and to arrange additional appointments. Please note that all members are encouraged to include a brief agenda of discussion topics.

Registration materials have been mailed and also are available on the members-only section of www.chpa-info.org. 

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Plans are underway for the 2007 Business Development Conference and Wal-Mart Immersion

CHPA Business Development Committee (BDC) Chair Randy Sloan, executive vice president, general manager, Del Pharmaceuticals, Inc., and his planning team are hard at work preparing the agenda for the 2007 Business Development Conference. This year's event, which will feature Wal-Mart as CHPA's immersion partner, will be held October 29–30 in Bentonville, Arkansas.

Members of the Business Development Conference planning group include:

• BDC Vice Chair Christopher DeWolf, president & chief executive officer, Lil' Drug Store Products, Inc.

• BDC Immediate Past Chair Adam Raczkowski, executive vice president, chief operating officer, chief financial officer, and general manager, W.F. Young, Inc.

• Greg Pulido, chairman & chief executive officer, Humco Holding Group (liaison to Wal-Mart)

• Phil Willis, president, Can-Am Care, Access Product Marketing

• Kirk Hodgdon, principal, growth catalyst, Bolin Fulcrum

• David Wendland, vice president, Hamacher Resource Group

• Alex Yakulis, vice president, business development, CROSSMARK

—Coming this fall— CHPA's Business Development Conference and Wal-Mart Immersion     Chuck Fehlig Vice President, DMM OTC Merchandising     October 29–30, 2007 Clarion Hotel & Convention Center Bentonville, Arkansas

Additional details on the Business Development Conference and Wal-Mart Immersion will be featured in future issues of the XNL.

 CHPA contacts: Ted Peterson and Phyllis Taylor | Back to the top

CHPA on the Road

CHPA staff travel inside the Beltway and beyond

David Spangler, senior vice president, policy & international Affairs, traveled to Hollywood, Florida, May 15–16 to attend The Nielsen Company's "Consumer 360" conference...

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Industry News

On Capitol Hill

Dextromethorphan Distribution Act introduced in the Senate

U.S. Senator Patty Murray (D-Wash.) introduced S. 1378, the Dextromethorphan Distribution Act of 2007 May 14. This initiative would prohibit the sale of unfinished dextromethorphan to any person who is not registered with FDA or a state regulatory authority to distribute or dispense pharmaceutical ingredients. The bill is nearly identical to legislation introduced in the House earlier this year by U.S. Representatives Fred Upton (R-Mich.) and Rick Larsen (D-Wash.). The Senate bill has been referred to the Committee on Health, Education, Labor, and Pensions.

CHPA contact: Kevin Kraushaar | Back to the top


Senate passes PDUFA reauthorization

The U.S. Senate passed the Food and Drug Administration Revitalization Act May 10, a measure that reauthorizes the Prescription Drug User Fee Act (PDUFA) and enhances FDA's drug and food safety programs. After nearly two weeks of debate on the Senate floor, the bill passed by a vote of 93-1. If not renewed by the Congress, PDUFA will expire September 30.

In addition to reauthorizing PDUFA, the legislation contains several measures aimed at improving the oversight of drug and food safety. If enacted, the bill would require makers of drugs approved under a new drug application (NDA) to create and submit a risk evaluation and mitigation strategy (REMS) for post-approval surveillance of the drug in certain situations. The bill also would require the Secretary of U.S. Department of Health and Human Services to expand the clinical trials database for all drugs approved under an NDA, promulgate regulations to enhance patient enrollment, and provide a mechanism to track subsequent progress of clinical trials. The regulations must be promulgated not less than 18 months after the bill is enacted.

The bill also would reauthorize the Best Pharmaceuticals for Children Act that was enacted five years ago to increase the number of studies conducted on the use of specific drugs in pediatric populations. This section of the bill would require that all OTC medicines marketed pursuant to an NDA or ANDA include a toll-free number of the manufacturer, distributor, or FDA MedWatch on the label. The effective date for label changes would be January 1, 2009.

In the area of food safety, the Senate bill would create an adulterated food registry and require food manufacturers and importers to report adulterated food to the agency. The bill also would give FDA new authority to fine food makers for failing to report contaminated food. Dietary supplements are specifically exempted from these provisions, and the bill states that the adverse event reporting system created by the Dietary Supplement and Nonprescription Drug Consumer Protection Act will not be affected. 

The U.S. House Committee on Energy and Commerce has held a number of hearings related to reauthorization of PDUFA, drug and food safety, medical devices, and generic biologics. Committee consideration of a Senate companion bill is expected in mid-June.

CHPA contact: Kevin Kraushaar | Back to the top


Nutritional Supplement Activities

Dietary supplement GMPs to be published soon

U.S. Senator Orrin Hatch (R-Utah) issued a press release May 9 announcing the Office of Management (OMB) has given final clearance for dietary supplement Good Manufacturing Practices (GMPs). According to Hatch, the GMPs are expected to be published in the next five weeks.

"Since it took an unusually long time to issue these final guidelines, I want to review the final version very carefully to make certain they are good regulations," said Hatch. "Every indication leads me to believe the Administration was very sensitive to the impact the GMPs might have on the industry, especially on small businesses."

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In Brief

Wirth named NACDS VP of state government affairs

The National Association of Chain Drug Stores (NACDS) issued a press release May 14 announcing that Gary Wirth, RPh, MBA, has been chosen as the association's vice president of state government affairs.

Wirth comes to NACDS from Ahold USA, where he was director, professional pharmacy services. His additional career experience includes holding a number of administrative positions for Giant Food, Inc., and serving as vice president, group pharmacy services for Physicians' Pharmaceutical Services, Inc.

Wirth is currently chairman of the Maryland Association of Chain Drug Stores. He will assume his new role at NACDS June 11.

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Harvard University hosts FDA symposium

Harvard University is hosting the third annual FDA regulatory and compliance symposium August 22–24 on its campus in Cambridge, Massachusetts. The purpose of the meeting is to help drug manufacturers prepare for the full impact of recent changes stemming from FDA and Congress. The event features two pre-conference workshops and the opportunity to select from multiple learning tracks including drug safety and risk management; advertising, promotion, and compliance; and innovative compliance strategies. Speakers include former FDA Commissioner Lester M. Crawford, DVM, Ph.D., senior counsel, Policy Directions, Inc.; former FDA Commissioner for Medial and Scientific Affairs Scott Gottleib, M.D., resident fellow, American Enterprise Institute; and former FDA Chief Counsel Daniel Troy, partner, Sidley, Austin, Brown & Wood. Additional information on the symposium is available online.

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