CHPA Executive Newsletter Friday, September 21, 2007 Issue No. 19-07 www.chpa-info.org

During the event, CHPA co-hosted a joint workshop entitled, “Combating Over-the-Counter and Prescription Drug Abuse Using the New CHPA/Community Anti-Drug Coalitions of America Community Toolkit,” led by Ann Comiskey, executive director, Troy Community Coalition. Attendees at the workshop received A Dose of Prevention: Stopping Cough Medicine Abuse Before It Starts toolkit and were provided with suggestions on how to effectively prevent cough medicine abuse in their own communities. After walking the participants through the toolkit, Comiskey offered special recognition to CHPA’s Five Moms Campaign's online social network (www.FiveMoms.com) as an important and effective place for people to join together against medicine abuse.

In addition to the workshop, CHPA sponsored an exhibit which provided the opportunity to network with many of the conference attendees and distribute educational materials on cough medicine abuse.

CHPA contacts: Elizabeth Funderburk and Katherine Bissell |  Back to the top




CHPA's 2007 Manufacturing Controls Seminar (MCS) is less than to weeks away. Scheduled for October October 3-4  at the Hyatt Regency New Brunswick in New Brunswick, New Jersey, the event will explore a number of technical, regulatory, and operational issues surrounding OTC medicine manufacturing.

The seminar will feature a number of expert speakers including Peter Bigelow, Ph.D., senior vice president, consumer healthcare, Wyeth Corporation, who will provide the keynote address. In his presentation, Bigelow will explain how Wyeth is working to meet an evolving market demand for new products.


Continuing Education Credits

MCS attendees also are eligible for credits for continuing education, which has been granted to CHPA by the New Jersey State Board of Pharmacy.

In addition to the general sessions, MCS attendees are invited to participate in a series of interactive workshops on the following relevant issues:

  • Process validation technology and science

  • Stability testing

  • Excipient toxicity testing

  • Quality agreements

  • How to set specifications

  • OTC manufacturing in Asia

  • Risk of importing low-cost raw materials and reduced testing of excipients

  • Change management and control

  • Importation and product logistics

  • FDA's inspection program and quality auditing

  • Drug master files

  • USP compendia project: discussion and update

  • Quality systems


Additional information and a registration form are available on CHPA's web site. Please note that the association's room block for the Hyatt Regency New Brunswick expires today, September 21. Rooms will then be assigned on a space- and rate-available basis. Contact the hotel directly at 732.873.1234.

CHPA contact: Fred Razzaghi |  Back to the top




Vice President, Government Relations Kevin Kraushaar, Director, Communications & Media Relations Elizabeth Funderburk, and Receptionist & Administrative Assistant Katherine Bissell traveled to Grand Rapids, Michigan, September 10-11, to participate in the eighth annual Michigan Substance Abuse Conference (See related story)...
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The U.S. Senate passed H.R. 3580, the Food and Drug Administration Amendments Act of 2007, by unanimous consent September 20, following House passage September 19 by a vote of 405-7. The bill, which now goes to the president for signature, makes the most significant changes to FDA’s authorities in a decade. Key provisions include reauthorization of the drug and medical device fee programs, reauthorization of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, drug approval and post-marketing reforms aimed at improving safety, and the establishment of a new adulterated food registry.

The centerpiece of the drug safety reforms is FDA’s new authority to require that so-called risk evaluation and management strategies (REMS) be submitted as part of a drug approval application, or adopted post-approval for drugs that already are on the market. 

Congress determined that the imposition of REMS is not necessary for OTCs. OTCs are not subject to the REMS requirement, nor are they covered by the FDA’s new authorities requiring post-market clinical trials and surveillance studies.

The reauthorization of the Best Pharmaceuticals for Children Act includes a provision requiring all nonprescription drugs marketed pursuant to a new drug application or an abbreviated new drug application to be labeled with the manufacturer’s or distributor’s toll-free number or the FDA MedWatch number. This requirement would be effective January 1, 2009.

Finally, the bill requires the creation of a “Reportable Food Registry,” to which reports of any article of food that poses a reasonable probability of a serious adverse health effect must be submitted within 24 hours. Dietary supplements are specifically excluded from this reporting requirement and Congress recognized that the adverse event reporting system established by the 2006 Dietary Supplement and Nonprescription Drug Consumer Protection Act will serve a similar purpose for those products.

CHPA contacts: Andy Fish and Kevin Kraushaar |  Back to the top



U.S. Representative John Dingell (D-Mich.), chairman of the House Energy and Commerce Committee, introduced H.R. 3610 September 20, the Food and Drug Import Safety Act of 2007. The bill would establish import fees on food and drugs, primarily to fund increased import inspections, including overseas inspections, by FDA. Fees would be assessed at $50 per line item for food and $1,000 per line item for drugs.

In addition to a number of new measures that apply only to foods, the bill also requires new country-of-origin labeling for foods, drugs, and devices.

CHPA contacts: Andy Fish and Kevin Kraushaar | Back to the top




The U.S. Senate Committee on Finance held a hearing September 18 concerning the implementation of the Combat Methamphetamine Epidemic Act that was signed into law in March 2006 (See March 10, 2006, XNL).  Committee Chairman Max Baucus (D-Mont.) opened the hearing , entitled “Breaking the Methamphetamine Supply Chain: Meeting Challenges at the Border,” by declaring the Combat Meth Act a success. He stated that meth lab seizures had declined 42 percent in 2006 and that the meth supply chain had been disrupted. However, Baucus noted that even though local production is down, meth is still the number one law enforcement problem because an estimated 80 percent of the illicit drug used in the United States is coming in from Mexico.

While U.S. Senator Chuck Grassley (R-Iowa) agreed that the Combat Meth Act has been a success, he said that more needed to be done to close the “smurfing loophole” to prevent meth cooks from going from store to store to purchase pseudoephedrine. Grassley advocated an electronic log book that would allow law enforcement to track all retail purchases of OTC medicine products that contain pseudoephedrine.

CHPA provided a written statement for the hearing record which agrees that the Combat Meth Act has been a success and that the number of small meth labs has decreased significantly. The association also calls upon Congress to fully fund the implementation of the law, support local law enforcement efforts, and designate additional money for education, prevention, and treatment.

CHPA contact: Kevin Kraushaar |  Back to the top



CHPA was one of 11 organizations that signed a September 14 letter to California Governor Arnold Schwarzenegger urging him to veto AB 1673. The bill would require rebates to be provided immediately to consumers at the point of purchase, thus putting the burden on sellers to reclaim the rebate from the manufacturer.

In the letter, the groups argued that the legislation could potentially eliminate rebates to consumers in California because retailers would have to staff new internal handling departments to recover the rebates. They pointed out that since manufacturers offer the majority of rebates, few retailers are likely to elect to incur the additional expense.

In lieu of the bill, the organizations instead offered support for changes to the rebate process including allowing a minimum of 30 days from the date of purchase for the consumer to submit the rebate request, specifying the personal information a company may ask for, requiring manufacturers to provide the rebate form along with the product or at the purchase location, and requiring a company to disclose contact information for consumers to check on the status of the rebate.

CHPA contact: Mandy Hagan |  Back to the top



FDA issued a notice in the September 21 Federal Register announcing that it is convening a public meeting to gather input on how the agency can make the best use of information technology (IT) to support its human drug application review process. To be held October 19 from 9:00 a.m. to 5:00 p.m. at FDA's office in Rockville, Maryland, the meeting will focus on three areas: 1) the content of IT plans that is most useful to external stakeholders, 2) the data standards and guidance that best support available IT capabilities and any implementation considerations, and 3) how agency architecture and IT solutions can best be applied to support public health mission needs.

Registration will begin at 7:30 a.m. on the day of the meeting and is on a space-available basis. Because seating is limited, FDA recommends that participants arrive early. Requests to make an oral presentation and written comments should be submitted to the Division of Dockets Management by October 5. The docket for the meeting will remain open to receive additional comments 15 days after the meeting date.

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FDA issued a proposed rule in the September 20 Federal Register that would amend the agency's regulation on the use of ozone-depleting substances (ODSs) in self-pressurized containers to remove the chlorofluorocarbon (CFC) "essential use" designation for OTC epinephrine metered-dose inhalers used for asthma relief.

The agency's proposed rule follows a January 24, 2006, joint meeting of its Nonprescription Drugs and Pulmonary-Allergy Drugs Advisory Committees. At that meeting, the joint committees voted 11 to 7 that the use of CFCs in OTC epinephrine inhalers should no longer be designated essential (See January 27, 2006, XNL).

In its proposed rule, FDA states that after consulting with the Environmental Protection Agency, it has tentatively concluded that that there are no substantial technical barriers to formulating epinephrine as a product that does not release ODSs, and therefore, the products would no longer be an essential use of ODSs. The agency adds that if the essential use designation is removed, epinephrine metered-dose inhalers containing an ODS could not be marketed after a "suitable transition period."

FDA is tentatively proposing December 31, 2010, as the effective date for the final rule removing the essential use designation for OTC epinephrine metered-dose inhalers. The agency says that it is proposing this date based on its "preliminary assumption that there will not be an inhaled epinephrine OTC drug product that does not contain ODSs on the market in the foreseeable future." However, the agency notes that it will consider December 31, 2011, and December 31, 2012, as alternative effective dates.

FDA says it will hold an open public meeting on the essential use of epinephrine on a date to be announced later. For now, the agency is inviting comments on the proposed rule, including whether publishing a final rule or the effective date of any such rule should be affected by the additional information the agency receives concerning the availability of an inhaled epinephrine OTC drug product that does not contain ODSs.

CHPA contact: Dr. Heinz Schneider |  Back to the top



FDA issued a notice in the September 20 Federal Register announcing that is conducting a series of four educational workshops on quality pharmaceutical production under current Good Manufacturing Practices (cGMPs). Held in collaboration with the Parenteral Drug Association, the workshops will provide participants with information on methodologies and implementation of cGMPs as applied to quality drug manufacturing. Speakers from both FDA and industry will be on hand to provide a regulatory and practical perspective on a variety of relevant topics.

Each of the two-day workshops will begin at 9:00 a.m. and conclude at 5:00 p.m. Following is a list of specific dates and locations: