Draft guidance on electronic submissions now available to industry

A new draft guidance for industry called "Providing Regulatory Submissions in Electronic Format―General Considerations" has been made available for public comment by FDA. The draft updates the original version released in 1999 and includes information relevant to the Center for Food Safety and Applied Nutrition (CFSAN). Comments on the guidance are due December 22. For more information, refer to the October 22 Federal Register notice or contact JoAnn Ziyad of CFSAN at (202) 418-3116.

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FDA uses enforcement authority to crack down on controversial performance enhancer

A statement issued by FDA October 28 announced that the Agency is aggressively pursuing, with the intent to prosecute, firms or individuals who manufacture, distribute, or market the controversial substance called tetrahydrogestrinone, or THG. Marketed by some manufacturers as a dietary supplement, FDA has determined that this synthetic steroid is actually an unapproved new drug that must undergo the Agency's rigorous approval system to ensure that it is safe to market.

In the interim, FDA warned consumers "while little is formally known about the safety of this drug, its structure and relationship to better known products leads FDA to believe that its use may pose considerable risks to health."

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Feinstein legislation would remove retail safe harbor for pseudoephedrine

United States Senator Diane Feinstein (D-Calif.) introduced legislation October 22 that would remove the retail safe harbor for OTC drug products that contain pseudoephedrine and are sold in blister packs. If enacted, retailers who sold more than nine grams of any combination of products containing pseudoephedrine would be subject to the registration, recordkeeping, and reporting requirements of the Controlled Substances Act. The bill, S. 1784, was referred to the Senate Judiciary Committee. CHPA opposes S.1784 which is similar to legislation introduced by Feinstein in the past. 

CHPA contact: Kevin Kraushaar

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Class action bill held up in the Senate

The Republican agenda in the U.S. Senate was once again stalled when leaders were unsuccessful in obtaining the necessary votes to invoke cloture, or limit debate, on a class action reform measure. The vote, taken October 22, fell one short of the 60 votes needed for cloture. The measure, S.1751, introduced by Senator Charles Grassley (R-Iowa), allows multi-state, national class action lawsuits to be heard in federal rather than state courts, preventing forum shopping by trial attorneys. Similar legislation, H.R.1155, passed the House of Representatives in June. Republican leaders have indicated that they will bring class action reform back to the floor of the Senate later this year or early next year.

CHPA contact: Amber Thyson

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Extend your reach at AEC

Get with the program

This is the last chance to be included in the printed 2004 CHPA Annual Executive Conference (AEC) brochure as a sponsor. Already ACNielsen; Hearst; Cargill Health & Food Technologies; Grey Worldwide; Reader’s Digest; and Information Resources, Inc., have signed on as sponsors of the March 17-19, 2004, conference, but more opportunities are available.

► Hospitality Lounge—March 17, 2004

► Networking Dinner—March 18, 2004

► After-Dinner Entertainment—March 18, 2004

► Welcome Favor Bags (These are the actual tote bags that carry all the sample OTC and supplement products distributed at the AEC.)

Companies interested in being included in the AEC brochure as an event or tote bag sponsor should contact CHPA’s Kass Kassouf now. Time’s running out.

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CHPA and NWHRC reach out to consumers

Interactive quizzes launched on web site

CHPA and the National Women’s Health Resource Center, Inc. (NWHRC), recently introduced a new interactive web site survey and quiz to learn more about consumer behavior in using OTCs. Some of the areas CHPA and NWHRC are seeking consumer input include how often they read OTC labels, where they turn for additional information on OTC products, and how they feel about making OTCs tax deductible medical expenses. After completing the survey section, participants are asked to test their "OTC savvy" with a brief quiz on the safe and responsible use of OTC medicines. Consumers who complete the survey and quiz also are eligible to sign up for a free copy of the Family Self-Care Handbook, a popular consumer information publication sponsored jointly by CHPA and NWHRC. 

Launched October 22, the combination survey and quiz is hosted on NWHRC's web site, www.healthywomen.org, and linked from CHPA's web site, www.chpa-info.org. It will run until November 18.

NWHRC "spotlight" message encourages women to take serious stock of their health

In conjunction with the interactive behavioral survey on OTCs, NWHRC President and CEO Amy Niles bylined this quarter’s “Spotlight on Consumer Health” feature. Located in the “Consumer Pages” of www.chpa-info.org, Niles’ article, Back to School, Back to Work, urges women as the primary persons making the healthcare decisions for their household, to take serious stock of their own health as well as their families'. 

Niles provides women with a laundry list of helpful healthcare reminders and recommendations such as using sunscreen on a regular basis, informing healthcare professionals about all of the medicines they are taking, and quitting smoking.

CHPA contact: Donna Edenhart

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Draft guidance explains how FDA handles marketed unapproved drugs

FDA has issued a new draft guidance entitled "Marketed Unapproved Drugs; Compliance Policy Guide." In an October 23 Federal Register announcement, FDA states that this document was created to describe how the Agency intends to exercise its enforcement authority with respect to drugs that do not have required FDA approval for marketing in the United States. According to FDA, several thousand drug products are marketed illegally in the United States, being subject to neither an approved drug application nor a final OTC monograph. Therefore, the Agency is planning on taking steps to ensure that the manufacturers of these products either comply with the appropriate approval provisions or remove the products from the market.

Comments on the guidance are due December 22. For additional information, contact Sakineh Walther, FDA Center for Drug Evaulation and Research, at (301) 827-8964.

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Administrative record reopened for OTC laxatives

As part of FDA's ongoing review of OTC drug products, the Agency has reopened until January 20, 2004, the administrative record for rulemaking for OTC laxatives. The Agency explains in the October 22 Federal Register, that since the tentative final monograph for OTC laxative drug products was published 1985, it has received new data and information on a number of occasions, thereby necessitating the reopening of the record. FDA has now determined that there are additional comments relevant to the final classification of conditions for marketing OTC laxatives under the final monograph and has reopened the record accordingly.

CHPA contact: Dr. Lorna Totman

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NDAC to look at Plan B at December meeting

According to FDA's advisory committee hotline, the next Nonprescription Drugs Advisory Committee (NDAC) meeting has been confirmed for December 16.  To be held jointly with the Advisory Committee for Reproductive Health Drugs, committee members will consider the safety and efficacy of a new drug application that proposes making the levonorgestrel (Plan B) emergency contraceptive pill available to consumers over the counter. This meeting is open to the public and will begin at 8:00 a.m. in the Hilton hotel in Gaithersburg, Maryland. For more information, call the advisory committee hotline at (800) 741-8138 and enter NDAC code #12541. 

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Comment period reopened for AER draft guidance

In response to an extension request, FDA announced in the October 17 Federal Register that it will reopen until December 16, the comment period for the draft industry guidance entitled "Providing Submissions in Electronic Format―Postmarketing Periodic Adverse Drug Experience Reports." Originally published June 24, this guidance addresses issues related to the electronic submission of postmarketing periodic adverse drug experience reports for drug products marketed for human use with new drug applications and abbreviated new drug applications.

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CDER will continue program to visit pharmaceutical sites

FDA's Center for Drug Evaluation and Research (CDER) announced in the October 23 Federal Register the continuation of its Regulatory Project Management Site Tours and Regulatory Interaction Program. Started in 1999, this program is intended to provide CDER regulatory personnel with an opportunity to tour pharmaceutical facilities and exchange information with their industry counterparts. The Agency believes that providing CDER staff with a better understanding of the industry and its operations will enhance review efficiency and quality. In addition, FDA wishes to improve communication and cooperation between CDER and industry.

The Federal Register notice served as an invitation to pharmaceutical companies interested in participating in the program. Proposed meeting agendas should be submitted by December 22. For more information, contact CDER's Patricia Stewart at (301) 827-7496.

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FDA brings its anti-counterfeiting initiative into a public venue

FDA held a public meeting October 15 on the Agency's anti-counterfeiting drug initiative. This effort is led by the FDA's internal task force on the issue headed up by Senior Associate Commissioner Bill Hubbard and Associate Commissioner for Regulatory Affairs John Taylor, who is responsible for FDA's field operations. The common themes among the presenters were a general agreement with FDA's own findings issued in an interim report October 2. As outlined by the commissioner's own comments during the meeting, the "U.S. drug supply is safe and FDA would like to ensure that it remains that way." 

Two recent counterfeiting incidents have uncovered organized operations beyond the U.S. border with the intent to adulterate the U.S. drug supply. The pharmaceutical manufacturing representatives at the meeting clearly demonstrated the severity of the issue and their commitment to work with FDA in support of its responsibilities. The associations representing pharmacies and wholesalers, committed to working with the Agency by asking for additional state and federal authority, specifically in state licensing and educational programs. The use of covert, overt and forensic technologies was also recommended in the interim report and was discussed by the Bureau of Engraving and Printing and the United States Secret Service.

CHPA contact: Fred Razzaghi

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FDA commissioner, deputy elected to the Institute of Medicine

The Institute of Medicine (IOM) announced October 27 the election of FDA Commissioner Mark B. McClellan, M.D., Ph.D., and Deputy Commissioner Lester M. Crawford, D.V.M., Ph.D., as members. IOM, part of the National Academy of Sciences, advises the federal government on health issues.

IOM has welcomed FDA scientists to its membership before, but this is the first time in history that both the commissioner and the deputy commissioner have been elected at the same time.

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Work continues on EU pharmaceutical legislation

Work continues on the European Union’s (EU's) pharmaceutical legislation package. Earlier this month, one of the key members of the European Parliament (EP) re-introduced an amendment to allow three years exclusivity for Rx-to-OTC switches in a recommendation for second reading on the package (see May 2 Executive Newsletter). Earlier this year, the EP supported three years on first reading, but the Council of Ministers and the Commission pushed it back to one year (see June 12 Executive Newsletter.) If the EP again votes for three years on its second and final reading, the Council could either accept the amendment or open a conciliation procedure with the EP.

An amendment to allow an additional year of exclusivity for a new indication to an existing product also has been re-introduced. At this stage in the process, however, amendments can only be re-introduced if they were adopted on first reading and then subsequently rejected by the Council. No new amendments can be introduced at this point.

The EP has set an ambitious timetable to complete its work on the pharmaceutical legislation package, with an amendment deadline of November 6 and hoped-for vote in the full EP in mid-December.

A related proposal for bibliographic applications for herbal medicinal products with well-established use is also moving forward. The Council of Ministers is expected to reach a common position in the next several weeks, before it returns to the EP for second reading.

CHPA contact: David Spangler

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FDA to hold public prep meeting for ICH conference

CHPA staff to serve on WSMI team headed to Osaka

A public meeting will be held November 3 by FDA to finalize details for the November 9-15 International Conference on Harmonisation (ICH) meeting and ICH 6 conference in Osaka, Japan. As noted in the October 17 Federal Register notice, the public preparatory meeting will be held from 1:00 to 4:00 p.m. in Rockville, Maryland. The agenda is available at http://www.fda.gov/cder/calendar/meeting/ich2003/nov3meeting.htm.

CHPA's Fred Razzaghi, director, technical affairs, will participate on the World Self-Medication Industry's (WSMI's) team that will address the area of quality at the ICH expert meetings in Osaka.

CHPA contacts: Fred Razzaghi

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CHPA staff travel inside the Beltway and beyond

CHPA President Linda Suydam, Vice President for Communications and Strategic Initiatives Virginia Cox, and Vice President for Corporate Development Ted Peterson traveled to Harrisburg, Pennsylvania, October 23 to meet with Rite-Aid President Mary Sammons and her senior executives in order to educate them on the new IRS ruling allowing for OTCs to be reimbursed through flexible spending accounts...

Eve Bachrach, senior vice president, general counsel and secretary; Virginia Cox, vice president for communications and strategic initiatives; Kevin Kraushaar, vice president of government relations; and David Spangler, vice president-international and assistant general counsel, met with key IRS officials in Washington, D.C., October 29 to discuss their views on OTC coverage in flexible spending accounts...

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IRI seminar to look at rules of engagement for obesity, wellness

There are still seats available for the November 13-14 Obesity/Wellness Leadership Seminar being cosponsored by Information Resources, Inc. (IRI) and St. Joseph's University. To be held in Philadelphia, Pennsylvania, this forum will offer a range of expert speakers from CHPA, IRI, Supermarket News, Chain Drug Review, the Food Marketing Institute, and the National Association of Chain Drug Stores. For more information, or to register for this event, click here.

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New publication focuses exclusively on AERs

Washington Information Source, Co. has created a new biweekly publication called Adverse Event Reporting News that is dedicated entirely to news surrounding adverse event reporting (AER) regulation. Available electronically, this periodical will provide information on firms that are getting cited by FDA, information on companies that are trying to obtain AERs filed by other companies, and FDA MedWatch and labeling updates. For more information, or to order a subscription for this product, visit http://www.fdainfo.com/whatsnew.html.

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Argentine firm offers "louse"y opportunity

A firm in Argentina is seeking partners for a U.S.-patented cosmetic or drug pediculosis product. The product is currently marketed as a cosmetic in Argentina, but would be considered a drug in the United States and other countries. The firm claims that the product is for daily use, is not toxic, and does not irritate the skin or eyes. For more information, e-mail Juan Tonelli or call (+54) (11) 4812-9759 or 4813-5681.

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

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