Industry coalition petitions FDA to rescind Part 11

An industry coalition comprised of CHPA and 12 other trade associations representing manufacturers of FDA-regulated products including drugs, foods, cosmetics, veterinary medicines, and medical devices filed a Citizens Petition with FDA September 17 to rescind 21 CFR Part 11. Part 11 was issued in 1997 to address security concerns related to the use of electronic records and signatures under Good Manufacturing Practice (GMP) regulations. It provides the criteria by which FDA is able to consider electronic records equivalent to paper records.

As the coalition's petition points out, however, the approach used in Part 11 is too prescriptive and actually inhibits technological innovation because the regulation was not structured to provide the flexibility needed as technologies change. More importantly, Part 11 has been superseded by the Government Paperwork Elimination Act (GPEA) of 1998, which was enacted by Congress one year after Part 11. GPEA covers the same electronic systems and addresses the same security concerns as Part 11. In addition, GPEA provides the flexibility that can adapt to changing technologies. Therefore, the industry coalition petitioned FDA to revoke Part 11 because it has become redundant through the application of GPEA standards and compliance with GMP regulations.

CHPA contacts: Dr. Doug Bierer and Fred Razzaghi

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CHPA seeks additional information from DEA on proposed security rule

CHPA filed preliminary comments with the U.S. Drug Enforcement Administration (DEA) September 20 requesting further information on the agency's proposed rule regarding security requirements for manufacturers, distributors, importers, and exporters of pseudopehedrine and ephedrine (See August 13 XNL). According to the proposed rule, published July 30, affected parties would be required to store pseudoephedrine and ephedrine ingredients and finished products in a secure safe or steel cabinet, cage, or room and to install a monitored alarm system.

In comments filed by the law firm Covington & Burling on behalf of CHPA, the Association said that it shares DEA's concerns regarding the diversion of pseudoephedrine and ephedrine products and is giving careful consideration to the proposed security requirements. CHPA further stated, however, that it does not believe that the rulemaking, as proposed, provides sufficient data on the thefts of listed chemicals, which are cited as the primary justification for the proposed enhanced security measures.

Specifically, the Association requested that DEA provide interested parties with more detail on the dates of the thefts in order to assess possible trends and patterns. Additionally, CHPA asked that the agency share any data concerning security measures in place at the affected facilities so that the adequacy of the agency's proposed requirements can be gauged. The Association argued that the omission of this basic theft information "will prevent interested parties from fully evaluating and meaningfully commenting on the proposed security measures and possible alternate approaches."

Finally, CHPA asked DEA to extend the comment period for the proposed rule so that full consideration may be given to any additional information the agency will provide. The deadline for comments is currently set for October 28.

CHPA contact: Eve Bachrach

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Registrants prepare for info-packed days at the MCS

The 2004 Manufacturing Controls Seminar (MCS) is now less than a week away. Industry professionals who will be traveling to Parsippany, New Jersey, to attend the September 30 - October 1 event should be prepared to participate in one of the most informative events of the year.

The MCS will not only be an educational meeting, but a very timely one as well, in light of the fact that FDA officials recently reported on the Agency's efforts to develop and implement an internal quality system to help it function more efficiently. Seminar participants are asked to engage FDA speakers at the MCS regarding the progress in this area. FDA also is expected to issue several new guidance documents in the near future that will reflect its current thinking on what industry should consider when using a more flexible and risk-based approach to drug product quality. Much of the MCS program was designed with this in mind.

In addition, virtually every avenue of Good Manufacturing Practice (GMP) regulations will be explored so that directors and managers can return to their companies with the assurance that they have the latest information available on GMP enforcement and compliance. FDA's John Taylor, associate commissioner for regulatory affairs, will address this issue for the Agency during the first day of the MCS.

Also on day-one, attendees may choose from seven concurrent sessions. The session topics include:

• "Lean" manufacturing science,
• Supply chain track and trace technology,
• Working with FDA,
• European Union drug quality directives and regulations,
• GMP process risk assessment, and
• OTC monograph product stability.

Another important highlight MCS attendees are looking forward to is the keynote address that will be delivered on the second day of the meeting by Christine Todd Whitman, former administrator of the U.S. Environmental Protection Agency (EPA) and governor of New Jersey. Whitman plans to share her unique perspective on several issues including EPA's success in risk-based regulation, the relationship between science and policy, and transparency between industry and regulators with respect to compliance matters.

Finally, the MCS will wrap up with four additional concurrent sessions on the following issues:

• Working with FDA;
• Process analytical technology;
• The United States Pharmacopeial Convention, Inc.'s, monograph acquisition campaign; and
• The Product Quality Research Institute.

The MCS program and registration form are available in the Meetings section of www.chpa-info.org. Contact the Hilton Parsippany directly at (877) 671-5746 to reserve a room.

CHPA contact: Fred Razzaghi

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CHPA participates in CADCA's Drug-Free Kids Campaign

CHPA was pleased to be a sponsor of the Community Anti-Drug Coalitions' (CADCA's) 2004 Drug-Free Kids Campaign awards dinner held September 14 at the Library of Congress in Washington, D.C. The event honored the National Football League (NFL) and NFL Commissioner Paul Tagliabue for setting a strong example by implementing tough drug prevention programs within the sport. Alvah Chapman, director and retired chairman and chief executive officer, Knight Ridder, Inc., and CADCA's founding chairman, also received accolades for his invaluable commitment and dedication to America's communities.

CADCA's mission is to build and strengthen the capacity of community coalitions to create safe, healthy, and drug-free communities. CHPA partners with the organization to address the troubling methamphetamine epidemic in the United States. The Association's work with CADCA includes outreach to the community anti-drug coalitions throughout the nation and implementation of the Meth Watch program.

For more information on CADCA, visit http://cadca.org.

CHPA contact: Elizabeth Assey

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Network with CVS/pharmacy execs at the BDC

CHPA members should register now to reserve a place at the 2004 Business Development Conference (BDC), which will be held November 3-4 in Providence, Rhode Island. The first day of the meeting will focus on the issue of growing the OTC business around the globe, as well as the effectiveness of in-store advertising sales. In addition, attendees will hear a special presentation given by syndicated columnist and political commentator Jack Germond, on the impact the 2004 U.S. presidential election will have on the OTC industry.

Day two of the BDC will be an immersion with CVS/pharmacy representatives. Members will have the opportunity to become better acquainted with CVS/pharmacy senior executives who will provide an overview of the company and discuss such issues as OTC growth strategies and emerging trends in the supply chain.

The 2004 BDC is open only to CHPA members and space is limited. Registration materials and the BDC program are available online in the Members Only portion of www.chpa-info.org. If you need your company user name and password to access this secured area of CHPA's web site, e-mail CHPA's Susan DiBartolo.

CHPA contact: Ted Peterson

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CHPA's 2004 Market Exchange was held September 23 in East Brunswick, New Jersey. Preliminary feedback from attendees indicates that this special member event was a huge success. Look for in-depth coverage of the meeting in the next issue of CHPA's Executive Newsletter.

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Montana joins the growing list of states to launch Meth Watch

Montana's governor recently announced its partnership with CHPA in implementing the Association's Meth Watch program in the state. The Montana Meth Watch program is completely voluntary and will begin in 12 pilot cities where methamphetamine abuse is a problem. These communities will apply for funding from the state to cover costs associated with training and will receive Meth Watch tool kits with store decals, shelf tags, and employee training materials.

CHPA was contacted by officials in Montana in August requesting assistance with executing a Meth Watch program. The Association provided funding to the state for printed materials, community awareness presentations, community training, distribution of materials, web site assistance, and staffing needs.

Jean Branscomb, who serves as policy advisor to Montana Governor Judy Martz and is coordinating this effort, recently told community leaders, "We really see this Meth Watch program as a starting point as all of you begin to approach the problem."

Montana becomes the sixth state to implement a Meth Watch program and has approached those states that already have programs in place for perspectives on effective execution. In conjunction with the Montana announcement, Washington State Meth Watch officials recently traveled to Big Sky Country to train community leaders in Montana's targeted communities.

Montana is currently in the process of notifying potential partners, including the retail community. Officials in the state hope to have the Meth Watch program up and running by November 1.

CHPA contacts: Elizabeth Assey and Virginia Cox

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Appropriations committee recommends $55 million to help fund the war on meth

The U.S. Senate Appropriations Committee approved the fiscal year (FY) 2005 Commerce, Justice, State, the Judiciary, and Related Agencies Appropriations bill September 15. The Senate bill includes $1.65 billion for the Drug Enforcement Administration, which is $16.4 million below the budget request, but $60.6 million above the FY 2004 level. The committee recommended $55 million for state and local law enforcement programs to combat methamphetamine production and distribution, to target drug "hot spots," and to remove and dispose of hazardous materials at clandestine meth labs. It also earmarked funds for specific state meth task forces.

CHPA contact: Kevin Kraushaar

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NIH may get a billion dollar raise

A bill approved September 15 by the U.S. Senate Appropriations Committee allocates $28.9 billion to the National Institutes of Health, which is an increase of $1.1 billion over the fiscal year 2004 appropriation and $380 million over President George W. Bush's budget request. The 2005 Labor, Health and Human Services, Education, and Related Agencies Appropriations bill includes $122 million for the National Center for Complementary and Alternative Medicine (NCCAM), a $5 million increase from 2004. Committee report language urged NCCAM to conduct research on women in their 30s and 40s with respect to bone health and nutrition, including the use of supplements and nutraceuticals, to determine whether such strategies can prevent osteoporosis and fractures later in life. It also was recommended that NCCAM research the effect of complementary and alternative medicine on bones and pain management in people with metabolic bone disease.

The committee recommended an appropriation of $1.03 billion for the National Institute on Drug Abuse (NIDA). Members encouraged NIDA to continue to increase its research and dissemination efforts on emerging drug problems, including expanding its work on the prevention and treatment of methamphetamine abuse. Additional funds were provided to the Office of Dietary Supplements with the purpose of expediting ongoing collaborations to develop, validate, and disseminate analytical methods and reference materials for the most commonly used dietary supplements.

CHPA contact: Kevin Kraushaar

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Senate bill encourages full enforcement of DSHEA

The Department of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies bill was approved by the U.S. Senate Appropriations Committee September 14. Funding in the bill for salaries and expenses for FDA totals $1.8 billion, which is $127 million more than fiscal year (FY) 2004. While the committee believes that the potential for dietary supplements to have positive health benefits has been demonstrated, it recommended that FDA continue its efforts to ensure the safety of the products and to fully enforce the Dietary Supplement Health and Education Act (DSHEA) of 1994. The budget request includes total funding of $5.4 million for FDA's Center for Food Safety and Applied Nutrition to improve its adverse events reporting system. In addition, FDA's Center for Drug Evaluation and Research (CDER) was appropriated $417 million in the legislation. The committee recommended that CDER's Division of OTC Drugs receive the same level of funding it did in FY '04, which was an unprecedented $10,040,000.

CHPA contact: Kevin Kraushaar

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Omega-3 fatty acids have second qualified health claim

FDA Acting Commissioner Lester M. Crawford, D.V.M., Ph.D., announced in a September 8 Agency news release the availability of a second qualified health claim for omega-3 fatty acids in conventional foods. The new claim is for reduced risk of coronary heart disease on foods containing eiscoapentaenoic acid (EPA) and docosahexaenoic acid (DHA) omega-3 fatty acids which are found in such foods as salmon, lake trout, tuna, and herring. FDA recommends that total consumption of EPA and DHA omega-3 fatty acids not exceed three grams per day and that no more than two grams per day be obtained from dietary supplements. Other regulatory requirements also must be met before the health claim can be used.

Manufacturers of dietary supplements have been allowed to use a similar health claim for omega-3 fatty acids since 2000 (see November 10, 2000, XNL). The claim may be used for EPA and DHA fatty acid-containing dietary supplements provided that the labeling does not recommend or suggest exceeding two grams daily intake and these limits are not exceeded under normal conditions of use.

Additional information on qualified health claims for dietary supplements and conventional foods is available on FDA's web site at www.fda.gov/ohrms/dockets/CITPETS/petitionlist1.htm.

CHPA contact: Dr. Marcia Howard

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FDA public advisory committee meets on GMP initiative

A public meeting will be held October 19-20 for FDA's Advisory Committee for Pharmaceutical Science. As detailed in a September 17 Federal Register notice, the committee will be updated on a number of issues on the first day of the meeting, including the Good Manufacturing Practices (GMPs) for the 21st Century initiative. Among the agenda items the committee will cover on the second day is a review of the Office of Pharmaceutical Science's plans and activities to take the organization towards the "desired state" of science and risk-based regulatory policies and practices as described under the GMP initiative.

Interested parties may provide oral or written presentations to the committee. Those wishing to present formal oral remarks should notify FDA's Hilda Scharen at SCHARENH@cder.fda.gov before October 12. Written presentations must be received by October 12.

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Opportunities in self-medication take center stage at China conference

The sixth World Self-Medication Industry (WSMI) Asia Pacific regional conference, which will be held October 26-29 in Beijing, China, is fast approaching. The conference will include a strong emphasis on the host country which is the eighth largest pharmaceutical market in the world and has a population of 1.3 billion. Perspectives on self-medication issues from other parts of Asia and around the globe will be covered as well.

Past issues of the Executive Newsletter have detailed some of the informative business sessions that will take place at the meeting, including those on regional drivers of change, regulatory developments, consumer attitudes, traditional and herbal healthcare approaches, access, and communications. A regulators' forum with authorities from several countries within the Asia Pacific region will cap off the event.

It's not too late to register for this important conference. Just visit www.SelfMed.cn or e-mail wsmireg@SelfMed.cn for information.

CHPA contact: David Spangler

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CHPA staff travel inside the Beltway and beyond

CHPA President Linda A. Suydam, D.P.A.; Vice President for Corporate Development Ted Peterson; Vice President - International, Assistant General Counsel David Spangler; Director, Technical Affairs Fred Razzaghi; and Director of Communications and Media Outreach Elizabeth Assey joined Assistant Commissioner of Health, Tennessee Bureau of Alcohol and Drug Abuse Services Stephanie W. Perry, M.D., and Coalition Advisory Committee member Judy Cushing, CEO, Oregon, Partnership, at the Community Anti-Drug Coalition's (CADCA's) 2004 Drug-Free Kids Campaign awards dinner held September 14 in Washington, D.C. (See related story)...

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Two CHPA members seek managers

Two CHPA member companies are seeking applicants for the following managerial positions:

• Manager, regulatory affairs & safety: A CHPA member company is seeking a qualified individual to manage its U.S. regulatory affairs and safety activities and to build the department. This position will focus on building a solid working relationship among marketing, product development, and legal, in addition to fostering growth through proactive regulatory positioning. Candidates must be capable of handling a diverse number of issues involving OTC medicines, dietary supplements, and cosmetic products. Areas of responsibility include advertising and claims support, regulatory submissions, information science, and product safety testing. Candidates must possess five to 10 years of experience in a healthcare company with a strong success record. An advanced degree or regulatory affairs certificate is a plus.
• Marketing brand manager: A CHPA member company is looking for a hands-on individual to take a leadership role in managing current brands and launching new ones. This position will drive all aspects of brand marketing, as well as provide support to sales. Specific requirements include consumer product marketing experience; brand building and product launch success; knowledge of retail distribution channels; ability to use health claims to support marketing efforts; knowledge of niche marketing; and experience in the food, health/diet product, OTC medicine, or dietary supplement industries preferred. Classic consumer product marketing experience and direct marketing knowledge is a plus.

For more information on either position, visit the Job Board in the Members Only section of CHPA's web site.

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FDA's acting commissioner headlines CRN's annual meeting

Lester M. Crawford, D.V.M., Ph.D., acting commissioner, FDA, is slated as the keynote speaker for the Council for Responsible Nutrition's (CRN's) annual conference on dietary supplements which will be held October 24-27 just outside of Washington, D.C. Crawford plans to discuss the Agency's views on the Dietary Supplement Health and Education Act 10 years after its passage. In addition to the acting commissioner, some of the other conference highlights will include a lobbying roundtable on building better relationships, a review of an innovative Canadian model for regulating natural health products, and panel discussions led by experts. For more details or to register for this event, visit www.crnusa.org/CNRAC.html.

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ASTM sponsors seminar on anti-viral claims for OTC topicals

The American Society for Testing and Materials International (ASTM) will present a seminar entitled OTC Topicals: Assessing the Need for Testing and Label Claims Against Viruses immediately following its quarterly meeting October 8 in Washington, D.C. Speakers from FDA, industry, and academia will host a number of sessions on such topics as FDA's perspective on regulating label claims of activity against viruses, methods for testing the activity of topicals against viruses, and the role human hands play in the spread of nosocomial viral infections. For more information on the seminar, visit ASTM's web site at www.astm.org and search for meetings of the E35 committee.

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FDLI holds introduction to drug law and regulation workshop

The Food and Drug Law Institute (FDLI) will host a two-day workshop November 4-5 in Washington, D.C., on the fundamentals of the laws and regulations that affect the pharmaceutical industry. This course will get down to basics by explaining elementary information such as the difference between OTC and Rx drug regulations, the history of drug regulation, the meaning of commonly used acronyms, and how FDA implements the laws handed down by Congress. The workshop also will explain how the Food and Drug Modernization Act of 1997 affects the industry. For more information on workshop, visit www.fdli.org/conf/introdrug/1104/.

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Manufacturing Controls Seminar
September 30-October 1, 2004
Hilton Parsippany

Parsippany, NJ
 

Business Development Conference
November 3-4, 2004
The Westin
Providence, RI

2005 CHPA Annual Executive Conference
March 10-12, 2005
Fairmont Turnberry Isle Resort & Club
Aventura, FL

2005 Regulatory & Scientific Conference
May 5-6, 2005
Mandarin Oriental
Washington, DC

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