CHPA Product Quality & Operations Workshop In Brief

Facilitating switch is CHPA’s top priority

Making “the next generation” of nonprescription drugs available through Rx-to-OTC switches is the greatest opportunity and paramount priority for the Consumer Healthcare Products Association, says Scott Melville, the trade group’s CEO. In a keynote address Oct. 6 at CHPA’s Product Quality & Operations Workshop, he acknowledged the sentiment that there are no more easy switches, but said “a second generation of OTC products … could be available through the switch process with some fresh thinking.” Melville noted that “for many years there’s been talk of a third class of drugs; that conversation is certainly still on the table” and new technologies could aid challenging switches. In May, former CHPA executive Andrew Fish recommended using diagnostics to facilitate consumer self-selection and switch opportunities (Also see "The Future Of OTCs: Self-Selection Meets Diagnostics, Genetic Personalization" - Pink Sheet, 16 May, 2011.).

FDA calls for OTC substance registration

Manufacturers of OTC drugs should submit to FDA’s substance registration system a listing of ingredients and their strengths for each product they sell, agency chemist Frank Switzer advises during a breakout session Oct. 7. Unlike with new drug application products, FDA often lacks visibility into monograph OTCs, and many firms do not comply with the requirement to submit the information to FDA, said Switzer, from the Office of the Chief Scientist. “For you in the OTC industry, this information is really important because you don’t have package inserts,” he said. About half the 30,000 ingredient listings on the substance registration system are OTC products, though many other nonprescription drugs available on the market are not listed in the database. FDA allows firms to submit inactive ingredient data confidentially to protect proprietary formulations.

Data systems slow FDA’s global reach

FDA is hamstrung by “terrible” information systems as it attempts to share data globally with foreign regulators, says John Taylor, counselor to the commissioner. “Not only do we have to improve those data systems internally, we need to work with our counterparts to ensure that there are data systems that allow us to talk in a timely manner to all our regulatory partners,” he said Oct. 6. Taylor added FDA must depend more on inspections by foreign authorities and third parties (Also see "Collaboration On Foreign Inspections Helps FDA Improve Resource Allocations" - Pink Sheet, 15 Aug, 2011.).

CHPA develops complaint handling tools

The association’s manufacturing controls committee recently formed a consumer complaint investigation trends subgroup, which is formulating a workflow chart to describe best practices for complaint intake and handling. Subgroup member Jan Przezdziecki, a quality assurance manager for Procter & Gamble’s oral care business, said the workflow, now in early draft phase, splits off into branches for handling adverse event reports and quality complaints. While quality complaints involving consumer preference do not require quality control action, product-related complaints may necessitate AER-level investigation and documentation, Przezdziecki said Oct. 6. The CHPA group also is developing a matrix document delineating mandatory and possible investigation actions. Przezdziecki said CHPA plans to get feedback from FDA’s Office of Compliance on the workflow and matrix once they are finalized.

ISMP takes formal stance on metric dosing

The board of the Institute for Safe Medication Practices approves a formal statement calling for the conversion of all drug measurements to the metric system and the use of weight-based dosing for pediatric medicines. The Horsham, Pa.-based nonprofit previously advocated the metric system to FDA in response to the agency’s draft guidance on dosage delivery devices for liquid OTCs (Also see "OTC Dosing Device Guidance Elicits Concern On Spoon Confusion, Added Cost" - Pink Sheet, 1 Feb, 2010.). Michael Gaunt, a medication safety analyst with ISMP, said Oct. 6 FDA should set a hard deadline for standardizing measurements and then industry should facilitate the changeover. “It’ll require an intense media campaign” and consumer education to transition from teaspoons and tablespoons to milliliters, he added.