• Nonprescription Drugs Advisory Committee meeting materials since 1997;

• Model labels developed by FDA using the new “Drug Facts” format;

• FDA’s complete index of warning letters;

• FTC advertising guidelines for dietary supplements and compliance materials on such topics as personal endorsements and comparative advertising; and

• DEA references on the Comprehensive Methamphetamine Control Act, including Form 510 applications for precursor chemical distributors.

CHPA members can access the ELF by using the Members Only log-in at www.chpa-info.org. If you are a member and need your password information for this secured area of the site, please contact Susan DiBartolo at sdibartolo@chpa-info.org.

 CHPA contacts: Eve Bachrach and Steve Mister

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FDA and industry will provide the ABCs of cGMPs at joint summer workshops 

The June 3 Federal Register included a notice from FDA announcing the Agency's upcoming series of summer workshops to be held in collaboration with the trade associations representing OTC, prescription, and generic drugs and the excipient industry. The workshops, to be be held three times this summer, will focus on the issue of pharmaceutical current Good Manufacturing Practices (cGMPs), including quality subsystems, areas of change control, and quality management. The series also will feature discussions surrounding current compliance issues and the status of the 21 CFR Part 11 draft guidance on electronic records and signatures (see March 7 XNL). 

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FDA/Industry Summer Workshops

June 16, 2003
Sheraton Meadowlands Hotel
East Rutherford, New Jersey
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July 14, 2003
San Juan Marriott Resort
San Juan, Puerto Rico
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August 12, 2003
Hyatt Regency Chicago
Chicago, Illinois

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A wide array of speakers representing both FDA and industry will round out what is expected to be yet another popular workshop series. The full conference program and registration details are available on www.chpa-info.org. Registrations should be mailed or faxed directly to CHPA at (202) 223-6835; no phone calls, please.

CHPA contact: Fred Razzaghi

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Only a few spots left for CHPA MarketPlace 2003 Business Exchange

Even though CHPA MarketPlace 2003 Business Exchange is still a few months away, there are only a few tables left. If you are interested in hosting a table, but have not yet registered, be sure to contact CHPA's Maria Sarabia at msarabia@chpa-info.org as soon as possible so that you do not miss the opportunity to participate in this exclusive Association event.

Reminder: Table hosts who have not yet sent in their top prospects lists MUST send the form, along with your meeting discussion topics to msarabia@chpa-info.org or ptaylor@chpa-info.org by close of business Monday, June 16, in order to have CHPA pre-arrange seven of your business appointments. 

Appointment schedules will be sent to table hosts and to all Active member Official Representatives and registrants in early July. After that time, table hosts will be free to fill in the remainder of their day’s appointments.

Detailed information and registration materials are located in the  Members Only section of  CHPA's web site. This meeting is not open to the public and you must be a member to view this information. If you are a member and have not already registered for the restricted section of the web site, contact CHPA's Susan DiBartolo at sdibartolo@chpa-info.org for your company-specific password information.

CHPA contact: Phyllis Taylor

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CHPA supports bar code concept, but seeks further clarification for OTCs

CHPA filed comments with FDA June 11 on the Agency’s proposal to require bar codes on drug products. FDA proposed a requirement March 14 that all prescription drugs and OTC medicines dispensed under an order and commonly used in hospitals must bear a National Drug Code (NDC) number embedded in a bar code on the label of such products (see March 21 XNL). CHPA’s comments ask FDA to further clarify and narrow which OTCs the Agency intends to include, since FDA has expressed an intent to cover a fairly limited number of products and shelf-keeping units (SKUs). 

In its submission, CHPA also encouraged FDA to allow the use of the universal product code, or UPC, without the NDC on OTC products. The Association pointed out that OTCs already use UPCs on their outer packaging. In addition, CHPA recommended that FDA not limit the rule to linear symbologies, in order to allow the coming generation of data matrix bar codes to flow through to the hospital setting.

CHPA contact: David Spangler

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FDA publishes two final OTC drug monographs

FDA recently published two final OTC drug monographs, one skin protectants and the other on antiperspirants.

Skin protectants

The Skin Protectant Final Monograph, published in the June 4 Federal Register, includes drug products for minor cuts, scrapes, burns, chapped skin and lips, poison ivy, poison oak, poison sumac, and insect bites. It also includes combinations with first-aid antiseptic ingredients and with sunscreens. Additionally, the Agency is preparing to allow skin protectant combinations with topical analgesics.

Twenty-nine active ingredients were considered in this final rule. Nineteen of those―colloidal oatmeal, topical starch, and lanolin among them―are included in the Skin Protectant Final Monograph. Vitamins A and D as skin protectants, other than as a component of cod liver oil, are non-monograph. FDA suggests that as many as five of the ingredients declared non-monograph as active skin protectants could be used as inactive ingredients in topical drug products.

The Agency requests comments by September 2, on reduced required labeling on products intended for use on lips; for products containing only cocoa butter, petrolatum, or white petrolatum; and for sunscreen drug products used on small areas of the face. Comments are sought as well on labeling for combinations of skin protectant and sunscreen active ingredients. 

The rule’s effective date is June 4, 2004. All products, except those with annual sales less than $25,000, must be in compliance by the effective date.  The compliance date for lower-volume products is June 6, 2005 .

Antiperspirants

The Antiperspirant Final Monograph, published in the June 9 Federal Register, includes all but one of the 19 active ingredients proposed by FDA 21 years ago in the tentative final monograph. Each of the active ingredients is aluminum based.  Buffered aluminum sulfate is not included in the final monograph because there is no U.S. Pharmacopeia-National Formulary compendial monograph for the buffer component, sodium aluminum lactate.

Under the final rule, antiperspirant products will be allowed claims of being “extra effective” and providing “24-hour protection” if they meet specific testing criteria. To aid in this process, the Agency has revised  a document entitled  “Guidelines for Effectiveness Testing of OTC Antiperspirant Drug Products,”

Two Citizen Petitions to FDA in 1992 questioned the safety of aluminum in anti­perspirants and requested that aluminum compounds not be considered Category I, or generally recognized as safe. The Agency concluded that evidence linking anti­perspirant ingredients to cancer or neurotoxicity, including Alzheimer’s disease, was insufficient to change their OTC monograph status. FDA however, has revised required labeling to alert persons with kidney disease to ask a doctor before using aluminum-containing antiperspirants.

December 9, 2004, is the rule’s effective date and the compliance date for all affected products except those with annual sales less than $25,000; the compliance date for small-volume products is June 9, 2005 .

CHPA contact:  Dr. Lorna Totman

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NDAC votes on ipecac

FDA’s expert panel for OTCs—the Nonprescription Drugs Advisory Committee (NDAC)—voted 6 to 4 June 12 that syrup of ipecac should not retain its OTC status. Several panelists cited gaps in the available literature and aired concerns about abuse potential.

CHPA contact: Dr. Lorna Totman

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FDA allows more time to relabel USP names

FDA has announced that it will give companies until September 1 to bring certain OTC labels into compliance with the United States Pharmacopeial Convention Inc. (USP) nomenclature for five new ingredient names. The FDA action is in response to a July 2002 petition from CHPA and the Cosmetic, Toiletry, and Fragrance Association (CTFA) asking for a one-year extension to relabel four sunscreen active ingredients that were assigned new names by USP, and to an additional request for another ingredient assigned a new USP name. FDA says it will exercise its enforcement discretion to permit the extensions.

To implement the extensions, FDA published a final rule in the June 3 Federal Register amending the ophthalmic monograph to change the USP name hydroxypropyl methylcellulose to hypromellose.  FDA indicated that after September 1, affected OTC ophthalmics “initially introduced or initially delivered for introduction into interstate commerce” containing the ingredient must bear labeling with the new USP name.

FDA published a related notice in the June 3 Federal Register announcing the availability of a guidance document entitled "Drug Products Containing Ensulizole, Hypromellose, Meradimate, Octinoxate, and Octisalate―Labeling Enforcement Policy." The guidance explains the Agency's position as it applies to hypromellose and the four sunscreen ingredients (ensulizole, meridimate, octinoxate, and octisalate) that were the subject of the CHPA/CTFA petition. FDA's response to the joint petition opted for exercise of enforcement discretion rather than a formal extension of time.

   CHPA contact: Eve Bachrach

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Comment period reopened for proposed amendment to internal analgesic tentative final monograph

FDA granted a 90-day extension for the submission of comments on its proposed rule that would amend the tentative final monograph (TFM) for OTC internal analgesic, antipyretic, and antirheumatic drug products. The Agency's proposal, originally published August 21, 2002 (see August 30, 2002, XNL), would amend the TFM to include ibuprofen as a generally recognized safe and effective analgesic and antipyretic active ingredient and also would amend the regulations to include consistent allergy warnings for all internal analgesics including nonsteroidal antinflammatory active ingredients. 

According to FDA's announcement in the June 4 Federal Register, the Agency took this action in response to a request it received before the original comment period closed. The new closing date for comments is September 2.

CHPA contact: Dr. Lorna Totman

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New legislation would add an Rx drug benefit to Medicare program

Legislation that would add a prescription drug benefit to Medicare has been introduced in the Senate Finance Committee. The bill, sponsored by Senate Finance Committee Chairman Charles Grassley (R-Iowa) and ranking Democrat Max Baucus (Mont.) would authorize $400 billion over 10 years to add the prescription drug benefit to the Medicare program. Participants could choose to stay in the traditional Medicare fee-for-service program or move to new private managed care networks. Although the legislation is bipartisan in nature, several amendments are expected to be introduced during the Senate Finance Committee mark-up scheduled for June 12. While sources indicate that the house bill will be similar to the senate bill, the house is also considering a provision that may require elderly people with higher incomes to pay more for the benefit. The house Republican leadership is expected to reveal the details of their Medicare legislation in the next few days. President George W. Bush has urged Congress to act on the measure before their July 4 recess.

CHPA contacts: Kevin Kraushaar and Amber Thyson

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Several measures pass the litmus test in the House this week

House bill extends antitrust protections

A bill passed the U.S. House of Representatives June 10 that extends antitrust protections to organizations that develop industry standards. Sponsored by Representative Jim Sensenbrenner (R-Wis.), HR 1086 provides relief from treble damages under the antitrust laws for organizations that provide details about the scope of their activities to both the attorney general and the Federal Trade Commission.

ONDCP reauthorization approved

The House Committee on Government Reform passed the reauthorization of the Office of National Drug Control Policy (ONDCP) June 4. The reauthorization package includes the Youth Anti-Drug Media Campaign which is focused on reducing and preventing drug use among young Americans. After objections raised by several members of the committee, the bill, HR 2086, specifically prohibits the use of Youth Anti-Drug Media Campaign money for partisan political purposes or to defeat any clearly identified state ballot initiative. The bill also establishes that the Partnership for a Drug-Free America will serve as the primary outside strategic advisor to the media campaign. CHPA supports the reauthorization of the Youth Anti-Drug Media Campaign. (See April 18 XNL.)

Class action lawsuit bill is okayed

With a vote of 253 to 170, the U.S. House of Representatives passed HR 1115, the Class Action Fairness Act of 2003 June 12. The bill allows multi-state, national class action lawsuits to be heard in federal rather than state courts, preventing forum shopping by trial attorneys. Similar legislation (S. 274) is pending in the U.S. Senate after having been approved by the Judiciary Committee April 11. (See April 18 XNL.)  

CHPA contacts: Kevin Kraushaar and Amber Thyson

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House subcommittee investigates bogus dietary supplement

The House Government Reform Subcommittee on Oversight and Investigations issued a subpoena for documents and testimony in connection with its investigation into a dietary supplement product marketed for weight loss in children. The subpoena compels the product's manufacturer to furnish the subcommittee with certain business records and marketing material associated with the supplement.

CHPA contacts: Kevin Kraushaar and Amber Thyson

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EU Council of Ministers reaches political agreement on pharmaceutical legislation

The European Union (EU) health ministers reached a political agreement on European Commission proposals on pharmaceutical legislation June 2. Paul Weissenberg, director for the single market, management and legislation for consumer products, Directorate-General Enterprise, European Commission, reported on highlights of the legislation during the Association of the European Self-Medication Industry (AESGP) annual meeting, June 4. (See related story.)

Weissenberg informed AESGP meeting attendees that the EU pharmaceutical legislation would streamline the European Medicines Evaluation Agency centralized procedure and answer questions about the agency’s management board. He pointed out that the scope of the centralized procedure would make that route mandatory for biotech products, and for medicines for AIDS, cancer, diabetes, and neurodegenerative diseases. Other new drugs would have the option to go through the centralized procedure or the mutual recognition route. Weissenberg noted that agreement also was reached on data protection periods. Compulsory centralized products would receive 10 years of data exclusivity, with the possibility of a one-year extension for new indications. Discretionary centralized or mutual recognition products would receive eight years of data exclusivity with the possibility of a two-year extension for new indications. Lastly, Weissenberg said that Rx-to-OTC switches would receive one year of data exclusivity when based on significant new studies. The one-year period applies apart from data exclusivity on the previously Rx product.

While the European Commission had recommended two years of exclusivity for switches and the European Parliament suggested three years, Weissenberg noted the importance of the Council’s recognition of the principle of incentives for Rx-to-OTC switch. European Commissioner for Enterprise and Innovation Erkki Liikanen echoed those comments in his remarks at the AESGP meeting.

The next steps are to formalize the Council position, with a target of early fall, and then the legislation returns to the European Parliament for second reading. Both Commission and Parliament speakers at the AESGP meeting noted they were anxious to meet the fall target for a common position so that the parliament can complete its second reading prior to EU expansion next May.

A companion proposal on herbal medicines is lagging a bit behind the larger pharmaceutical legislation, but Commission and Parliament speakers noted that they hoped to complete work on it as well to consider the pharmaceutical package as a whole.

CHPA contact: David Spangler

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AESGP meeting looks at 'innovating self-care'

In addition to covering the latest developments on European Union (EU) pharmaceutical legislation, speakers at the Association of the European Self-Medication Industry (AESPG) annual meeting, June 4-6 in France, provided perspectives on innovating self-care that included informed patients and national government initiatives. Alasdair Breckenridge, University of Liverpool, U.K., noted changes underway in that country to improve consumer access to medicines and to make greater utilization of healthcare professionals in addition to doctors to more efficiently deliver healthcare. For example, he cited instances which would allow nurses and, perhaps later, pharmacists, to prescribe certain medicines. He also reported on 2001-02 U.K. initiatives to improve the Rx-to-OTC switch environment. In the year since, progress has included the removal of certain advertising restrictions, shifting nicotine replacement therapies from pharmacy to general sale, a pending switch of omeprazole, the switch of emergency contraceptives, and, he opined, “the debate will soon be joined” on the switch of statins.

A number of patient advocates and disease group representatives spoke on their desire for more access and more information on medicines, as well as for a more in-depth dialogue with manufacturers. For instance, Angela Coulter, Ph.D., The Picker Institute, U.K., reported on results of an eight European country survey showing a roughly 10 percentage point gap between consumers who want to participate in treatment decisions with their doctors and consumers who report having sufficient involvement in treatment decisions. Similarly, Robert Johnstone, president, Arthritis & Rheumatism International, explained that self-management programs resonate with disease groups, building confidence in patients, in turn allowing them to take more control of their own healthcare.

 CHPA contact: David Spangler

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FDA to hold prep meeting for ICH and ICH 6

FDA has scheduled a public meeting in preparation for both the July 15 International Conference on Harmonisation (ICH) meeting in Brussels, Belgium, and the November 12-15 ICH 6 conference in Osaka, Japan. The preparatory meeting will be held June 24 from 10:00 a.m. to 1:00 p.m. at FDA's office in Rockville, Maryland. For more information, read the complete meeting notice published in the June 3 Federal Register or contact FDA's Kimberly Topper at Topperk@cder.fda.gov.

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FDA is seeking individuals to represent industry on CDER advisory committees

FDA announced in the June 5 Federal Register that the Agency is seeking nominations for nonvoting industry representatives to serve on public advisory committees for its Center for Drug Evaluation and Research (CDER). The Nonprescription Drugs Advisory Committee is among the 16 CDER advisory committees currently accepting names. A candidate may be either self-nominated or nominated by an organization by sending a current curriculum vitae (c.v.) and the name of the committee of interest to: Igor Cerny, Advisors and Consultants Staff (HFD-21), FDA, 5600 Fishers Lane, Rockville, Maryland 20857. 

In addition, FDA has requested that any industry organization interested in participating in the selection process for the nonvoting industry representatives should express this interest in writing to FDA's Igor Cerny at the above address. (Persons who nominate themselves are not eligible to participate in the selection process.) The Agency will subsequently respond to each interested organization with a complete list of all such organizations, nominees, and c.v.s. The organization will then have 60 days to vote for committee nominees. If no candidate is chosen within the 60-day timeframe, the Agency retains the right to make the final decision.

All nomination materials and letters requesting participation in the selection process should be sent to FDA by July 7.

CHPA contact: Dr. Lorna Totman

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CFSAN seeks input for FY '04 program priorities

As part of its annual planning and budgeting process, FDA's Center for Food Safety and Applied Nutrition (CFSAN) is reviewing its current programs in order to set priorities and establish work product expectations for fiscal year (FY) 2004. FDA issued a request in the June 5 Federal Register seeking input that would help the Agency develop CFSAN's 2004 work plan which will be similar to the FY 2003 plan that focuses heavily on protecting the nation's food supply from terrorism.

Comments and suggestions for CFSAN's FY 2004 plan should be submitted to FDA by August 4.

CHPA contact: Dr. Doug Bierer

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CHPA staff travel inside the Beltway and beyond

Vice President & Associate General Counsel Steve Mister attended a June 2 seminar sponsored by Prop 65 News in Sacramento, California. The day-long conference featured updates on Prop 65 reform efforts, the potential for pre-emption of Prop 65 by federal law, recent litigation developments, and a reexamination of the science behind the law.

Association President Linda Suydam and Vice President-International & Assistant General Counsel David Spangler attended the Association of the European Self-Medication Industry's annual meeting and related World Self-Medication Industry Board and committee meetings, June 3-6, in Cannes, France (see related stories)...

CHPA President Linda Sudyam, Vice President of Government Relations Kevin Kraushaar, and Vice President for Communications and Strategic Initiatives Virginia Cox, participated in a June 10 press briefing in St. Louis, Missouri, announcing the launch of a CHPA, PDFA, and AAP methamphetamine educational campaign (see related story)...

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IPEC-Americas conference to examine marketability of excipients

The International Pharmaceutical Excipients Council of the Americas (IPEC-Americas) is hosting a conference to explore the major regulatory, compendial, business, and scientific issues that affect the marketability of pharmaceutical excipients. Specific program topics include bioterrorism and the global supply chain, vendor certification, and good distribution practices. The event will be held September 30 - October 1 in Alexandria, Virginia. For additional details, visit www.ipecamericas.org.

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NBJ summit to convene in San Diego

The Nutrition Business Journal (NBJ) is sponsoring the sixth annual Newport Summit July 16-18 in San Diego, California. The summit is a retreat for executives involved in the nutritional supplement and food industry. Topics to be discussed at the relaxed venue include obesity and weight loss, and supplements versus OTC medicines versus prescription drugs versus foods. For more information or to register, visit www.newportsummit.com.

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FDA/Industry Summer Workshop
June 16, 2003
Sheraton Meadowlands
East Rutherford, New Jersey

FDA/Industry Summer Workshop
July 14, 2003
San Juan Marriott Resort & Stellaris Casino
San Juan, Puerto Rico

FDA/Industry Summer Workshop
August 12, 2003
Hyatt Regency Chicago
Chicago, Illinois

CHPA MarketPlace 2003: The First CHPA Business Exchange
September 18, 2003
Hilton East Brunswick
13 Tower Center Blvd.
East Brunswick, New Jersey

Manufacturing Controls Seminar
October 9-10, 2003
Hilton Parsippany Hotel
One Hilton Court
Parsippany, New Jersey

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

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