2^nd CHPA/FDA seminar takes on monograph challenges

CHPA’s Scientific Affairs Committee and FDA sponsored the second in a series of educational seminars for Agency and OTC industry personnel October 2 with the topic “OTC Drug Monographs: Challenges for the Future.” The speakers, from FDA and industry, explored how the monograph review process differs from the new drug application (NDA) approval process and the challenges presented by the monograph system for both industry and FDA. Several interactive case studies were used to illustrate options a manufacturer could choose in developing new claims, product dose forms, or product enhancements of current OTC monograph drugs.

A joint CHPA/FDA steering committee is designing at least two more seminars in 2004 on OTC drug topics of mutual interest.

CHPA contact: Dr. Lorna Totman

Back to the top

BDC is sold out—wait list registrations will be accepted

All 120 seats for the Business Development Conference (BDC) have been reserved by CHPA members anxious to attend the Wal-Mart-focused October 27-28 conference in Bentonville, Arkansas. Due to the unprecedented interest in the conference, however, wait-list registrations will be accepted as cancellations are received. To register for the wait list, download the conference registration form from the Members Only section of www.chpa-info.org and fax it to CHPA’s Maria Sarabia at (202) 223-6835. 

We are pleased to announce that the following companies have graciously offered to sponsor events at the conference, thereby helping to make it an even better networking opportunity:

As always, we sincerely appreciate the generosity of the CHPA membership. Their generosity adds value to CHPA events and helps defray the registration costs for all attendees.  

CHPA contacts: Ted Peterson and Phyllis Taylor

Back to the top

Benefit-risk management takes center stage at RSC 2003

The Regulatory and Scientific Conference (RSC) is now just three weeks away, but it’s not too late to register. With the theme “The New Age of Benefit-Risk Management,” the conference will be held November 6-7 at The Fairmont Hotel in Washington, D.C. 

Insights from Washington insider Kay Holcombe, executive vice president, Policy Directions, Inc., on the role of self-medication in our future healthcare system will be a highlight of the first general session. The session program focuses on the timely topics of benefit-risk assessment for OTC products, the role and impact of epidemiology in benefit-risk assessment, and FDA’s use of epidemiology study data. The featured speakers are Peter A. Gross, M.D., chairman, Department of Internal Medicine, Hackensack University Medical Center; J. Michael Gaziano, M.D., director of cardiovascular epidemiology, Division of Preventive Medicine, Brigham and Women’s Hospital, and principal investigator in the Physicians’ Health Study II; and Paul J. Seligman, M.D., MPH, director, Office of Pharmacoepidemiology and Statistical Science, Center for Drug Evaluation and Research (CDER), FDA. They will be joined by Charles J. Ganley, M.D., director, Division of Over-the-Counter Drug Products, Office of Drug Evaluation V (ODE V), CDER, FDA, and Eric Brass, M.D., chair, Department of Medicine, Harbor-UCLA Medical Center, in a panel discussion moderated by Randy P. Juhl, Ph.D., vice chancellor for research conduct and compliance, University of Pittsburgh.

Three concurrent workshops will provide opportunities for learning and interaction among conference participants. The workshop topics are the benefit-risk equation for chronic-use OTC switch candidates, tools and rules for improving benefit-risk assessments, and optimizing the FDA Nonprescription Drugs Advisory Committee.

The second general session will emphasize the roles of the media and public relations professionals in communicating healthcare issues, with presentations by Nancy Snyderman, M.D., vice president of medical affairs, Johnson & Johnson, and Richard W. Edelman, president and chief executive officer, EDELMAN. Conference participants also will hear from Curtis J. Rosebraugh, M.D., MPH, deputy director, Division of Over-the-Counter Drug Products, ODE V, CDER, FDA, about current OTC drug issues at FDA.

_________________________

Provided rooms are available, 
the RSC room rate of $199 per night 
will remain in effect through October 17
_________________________

A preliminary program and registration materials are available on CHPA’s web site. Room reservations should be made directly with The Fairmont Hotel at (800) 441-1414. The Fairmont has agreed to honor the special CHPA conference rate of $199 per night through October 17, provided rooms are available. 

CHPA thanks this year’s RSC sponsors: 

• McNeil Consumer & Specialty Pharmaceuticals;
• Novartis Consumer Health, Inc.;
• Perrigo Company; 
• Pfizer Inc.; and
• The Procter & Gamble Company.

CHPA contact: Dr. Lorna Totman

Back to the top

CHPA provides recommendations on safety reporting

In comments to FDA October 14, the Association commended the Agency's goal of moving towards global harmonization of safety reporting requirements for drugs as enumerated in a March 14 proposed rule, but recommended reconsideration of the impact on OTCs of many of the proposed provisions. 

In its comments, CHPA supported the "underlying rationale" for the Safety Reporting Requirements for Human Drug and Biological Products proposed rule, highlighting how it "will save considerable valuable resources for both industry and the governmental agencies in the processing of safety reports and allow more effective pharmacovigilance and continued protection of the public health." However, in terms of the postmarketing safety reporting requirements for consumer healthcare products marketed under new drug or abbreviated new drug applications (NDA and ANDA, respectively), the Association pointed out that the practical implications of the proposal could be "problematic" and in some cases "extraordinarily resource-intensive," leaving the benefit to the public debatable.

CHPA raised a number of points within its nine pages of comments, including: 

• The proposed definition of a suspected adverse drug reaction was too broad and inconsistent with certain International Conference of Harmonisation (ICH) guidelines on the subject. 
• FDA should concentrate on the quality of safety reports rather than their source, consistent with ICH. 
• Only those medication errors with a "serious" adverse event should be submitted in expedited reports for OTC NDA and ANDA products.  

CHPA contact: Dr. Lorna Totman

Back to the top

CHPA and PhRMA nominate Alfano to NDAC

CHPA and the Pharmaceutical Research and Manufacturers of America (PhRMA) nominated Michael C. Alfano, D.M.D., Ph.D., to serve as the industry liaison to FDA's Nonprescription Drugs Advisory Committee. Alfano is the dean of New York University's College of Dentistry and has participated in previous NDAC meetings as a guest participant. The associations sent Alfano's nomination October 10 to the Advisors and Consultants Staff department within FDA's Center for Drug Evaluation and Research. 

CHPA contact: Dr. Lorna Totman

Back to the top

FDA publishes interim final bioterrorism rule
Dietary supplement facilities must register by December 12

FDA published interim final rules October 10 implementing the food registration and the import notification provisions of the Bioterrorism Act. The interim rules will require dietary supplement facilities to register with FDA by December 12 and to begin filing prior notices of imports by that deadline.

Food facilities can register electronically

As mandated by the bioterrorism statute itself, FDA will require the registration of all facilities engaged in the manufacturing, processing, packing, or holding of food, including dietary supplements, for consumption in the United States. The mandate applies to domestic as well as foreign facilities. whether food from the facility enters interstate commerce or not. Domestic and foreign food facilities have between October 16 and the December 12 deadline to register. Electronic registration is available at http://www.fda.gov/furls. 

Importers must file prior notice, timing depends on method of shipment

The second interim final rule requires prior notice of imported food, including dietary supplements, beginning December 12. FDA must receive prior notice no more than five days before foods are imported or offered for import into the United States. FDA has different minimum timeframes for road, air and rail, ship, or mail arrivals. FDA intends to provide a transition period in enforcement policies through a guidance to FDA staff, during which time the Agency will emphasize education to achieve compliance.  

FDA addressed some CHPA concerns

CHPA submitted written comments to these proposed rules earlier this year. FDA responded favorably to CHPA’s concerns about the breadth of term “food” that would have included substances that come into contact with food during processing or packaging. That would require the plant where the contact substance is manufactured to register, as well as the facility where the food is manufactured or processed. In the interim final rule, FDA expressly excludes food contact substances, including food packaging material, from the definition of food. Thus, manufacturers of food packaging will not be required to register those facilities under the interim rule nor will they be required to provide prior notices of imported food contact substances.

FDA also reacted favorably to CHPA concerns about the amendment process and time lines for filing import notices. CHPA had pointed out that the proposed rules actually created disincentives for filing notices as far in advance as possible and discouraged filing amendments as more information about the contents of a shipment became available. In response, FDA reduced the deadline for submission of prior notices and adopted a more flexible approach that accounts for differences among shipments arriving by rail, road, water, or air. The interim final rule also eliminates the requirement for amendments and updates because of the shorter timeframe in which to file.

In other bioterrorism-related matters, FDA announced October 8 it will conduct a November 6 meeting of the Science Board to discuss FDA's Food Security Program. On October 10, the Agency announced the availability of a risk assessment for food terrorism and other food safety concerns.

CHPA contact: Steve Mister

Back to the top

FDA’s expert panel on pharmaceutical science to convene

The Advisory Committee for Pharmaceutical Science will meet October 21 – 22 in Rockville, Maryland. The panel’s agenda for October 21 includes receiving updates from FDA’s manufacturing, clinical pharmacology, and pharmacology/toxicology subcommittees, as well as a discussion of the Agency’s draft guidance on Process Analytical Technologies. For more information about this meeting, please review the Federal Register notice on the subject. 

Back to the top

FDA announces staffing changes

A number of key FDA professionals have taken new posts recently. 

• Margaret O'K. Glavin was appointed FDA's new assistant commissioner for counter-terrorism October 10. Glavin is a food safety policy expert and will be the senior counter-terrorism advisor to the commissioner.
• Paul Seligman, M.D., has been named acting director of the Office of Drug Safety.
• Steve Galson, M.D., will be the acting head of the Center for Drug Evaluation and Research, while the center's director, Janet Woodcock, M.D., completes a six-month assignment in the Office of the Commissioner. 

Back to the top

OTC ingredient lists updated

The Association of the European Self-Medication Industry (AESGP) has updated a list of over 200 widely used ingredients on their prescription or nonprescription status in 32 countries, both in Europe and beyond. This year’s ingredient status list includes a number of new ingredient entries and five countries not included in previous editions, such as China, the Czech Republic, and Poland. The list is heavily footnoted with selected additional information on conditions and dosages.

The ingredient lists are available at www.aesgp.be/Ingredients/intro.html, organized under EU countries, non-EU European countries, and world.

CHPA contact: David Spangler

Back to the top

EU pharmaceutical legislation moving forward

The EU Council of Ministers formally adopted a common position on the two key pieces of the EU’s pharmaceutical legislation package, clearing the way for its return to the European Parliament for the latter’s second and hopefully final round of consideration in the next few months. The legislation includes one year of data exclusivity for Rx-to-OTC switches with “significant” tests and trials and does not require that classification status be universal across the EU. For more information on the directive and its move through the legislative process, see the May 2 and June 12 Executive Newsletters. 

CHPA contact: David Spangler

Back to the top

CHPA staff travel inside the Beltway and beyond

CHPA President Linda Suydam, Vice President of Government Relations Kevin Kraushaar, Vice President for Communications and Strategic Initiatives Virginia Cox, and Director of Government Relations Nancy Bukar traveled to New York City October 15 to attend the Partnership for a Drug-Free America's first gala event in honor of Jim Burke, former chairman and CEO of Johnson & Johnson. The festivities were emceed by television news anchor Tom Brokaw...

Back to the top

PharmaCongress.com readies for regulatory, compliance, and best practices forum

The Fourth Annual Pharmaceutical Regulatory and Compliance Congress and Best Practices forum is slated to take place in Washington, D.C., November 12-14. The agenda is packed with information on enforcement issues, compliance programs and best practices, advertising guidelines, etc. Continuing education credits are available. For more information and to review the conference program, visit www.pharmacongress.com. 

Back to the top

2003 Business Development Conference
October 27-28, 2003
Clarion Hotel
Bentonville, Arkansas

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

Back to the top