Jan. 26, 2017
In 2016, the Education Committee produced four robust webinars, and industry leaders united at two membership meetings. As we step forward into 2017, it’s a good moment to reflect on other highlights that brought value to the membership.
Legal & Regulatory
- AAHP recently met with the Federal Trade Commission (FTC) regarding the Nov. 15 enforcement policy statement on marketing claims for over-the-counter (OTC) homeopathic drugs; members have received updates and education on this very important topic.
- AAHP encouraged the S. Food and Drug Administration (FDA) to provide clear and open communication on their ongoing investigation of the safety of homeopathic teething medicine.
- Staff attended and reported on an FTC workshop on disclaimers in general, noting that drafting and testing consumer disclosures is a complex task.
- At the Sept. 23 semiannual conference, AAHP presented a special lifetime achievement award to U.S. Sen. Barbara Mikulsky of Maryland for her support of alternative therapies.
Two officials from FDA presented two Compliance Thru Education webinars, providing direct insights into the issues that concern the agency. Their participation also demonstrates another step AAHP has taken toward fostering a more collaborative relationship with the agency.
AAHP’s new partner The Markens Group boosted the frequency, readability and value of the information provided to members through AAHP NetworkNews. The new and improved newsletter reaches more than 200 multiple readers at member companies. On average 35 percent of the recipients open the newsletter, of which 28 percent click at least one link in the newsletter.
Top 10 Most Engaging Links
- “Homeopathic Drug Labels: Rx or OTC?” offers guidance on effectively labeling your homeopathic products.
- “Understanding OTC Monograph Reform: Where Do We Stand Now?” is an important update because the
traditional OTC review is about the only forum where FDA sets out acceptable and unacceptable OTC claims.
- “2016 Annual Meeting Recap”
- “FDA Guidance for Industry – Request for Quality Metrics” alerts companies that FDA is seeking comments on this subject.
- “The Story of Homeopathy Told in Upcoming Feature Documentary”
- “Do Your Dosage Forms Appeal to Consumers?” reviews current research regarding consumer attitudes that may help you develop new products or promote existing offerings.
- “Annual HPCUS Meeting Recap”
- “Hatch, Paulsen Introduce Bill to Enhance HSA, FSA”
- “U.S. FDA Establishment Inspections” outlines areas that the industry needs to work on relevant to Good Manufacturing Practice (GMP) inspection. (Look for this in the members-only section.)
- Webinar Review: FDA’s View on Compliance
The following articles from 2016 are also available to help members support and grow their businesses.
- “Adulterants in Your Botanical Source Materials—How Do You Know?” reminds members to be vigilant against adulterated source ingredients; “Is Your Arnica Contaminated” takes this a step further, differentiating “Mexican arnica” from Arnica montana.
- “Congress to Tackle “Must Pass” FDA Legislation Next Year” reviews the Prescription Drug User Fee Act (PDUFA) that authorizes FDA to collect fees from Rx pharmaceutical companies to help fund the agency’s drug review work.
- “The Tale of the Contract Manufacturer: A Story Based on an AAHP Member Question” illustrates that contract manufacturers are also responsible for the products they produce.
- “Document Management Systems: Don’t Be Afraid to Go Digital” tells the benefits of making this transition to those companies that are hesitant.
- “Only the Best Products Should Reach the Market” outlines how to develop a marketable new homeopathic product.
- “The Importance of Standard Operating Procedures” provides instructions on creating a culture where quality objectives are transparent, well understood, and acted upon routinely. SOPs are essential for any plant’s effectiveness and efficiency, and they are a regulatory requirement in the pharmaceutical industry.
- “Label Comprehension Studies for Nonprescription Drug Products” instructs on how to conduct label comprehension studies that are sometimes required by FDA. A label comprehension study assesses the extent to which consumers understand the information on nonprescription drug product labeling and then applies this information when making drug product use decisions in a hypothetical situation. Data derived from a label comprehension study can identify areas on the label that would benefit from clearer or simpler presentation of important consumer information.
- “A Trump Administration and a Republican-Controlled Congress: An Assessment and Outlook of the Political and Regulatory Climate for 2017” is an interpretation of how the recent transition might affect FDA, and therefore the homeopathic industry.
- “Regulatory Policy Analysis” explains various tools for evaluating the regulatory framework for homeopathic drugs—a good primer for those working in government affairs for your company.