NACDS comments to FDA on track-and-trace technologies
ALEXANDRIA, Va. The National Association of Chain Drug Stores submitted comments yesterday to the Food and Drug Administration in which the association highlighted questions and technical challenges that suggest track-and-trace and related technologies are still in their “nascent” stages and their mandatory use inappropriate.
NACDS submitted two sets of comments, on the issues of “Technologies for Prescription Drug Identification, Validation, Track and Trace, or Authentication,” and “Standards for Standardized Numerical Identifier, Validation, Track and Trace, and Authentication for Prescription Drugs.”
“We are proud of the systems and initiatives that our members have developed with other industry stakeholders to improve the integrity of the U.S. drug supply chain,” NACDS wrote. “Our members have and continue to work diligently to undertake efforts to secure the pharmaceutical supply chain from counterfeit drugs.
“Prescription drug tracking and tracing technologies, although promising, face a number of challenges before they could be considered reliable and acceptable, and could be deployed across the drug distribution system, particularly down to the level of pharmacies and other dispensers,” NACDS wrote. “Significant industry wide challenges must be addressed and overcome before these technologies can be determined to be an integral and cost-effective part of the prescription drug distribution supply chain.”
NACDS said implementation challenges are diverse and numerous. They range from developing a reliable method for “identifying” products with a designation that contains all appropriate information, to varied and emerging frequencies used in RFID tags and the multiple readers that would be needed for each, to the unknown impact of radio frequency energy on biologics, to the impacts on existing relationships between trading partners.
In response to a question about blocking counterfeits, NACDS emphasized the safety of the U.S. drug distribution system and urged a focus on evaluating potential entry points of counterfeits and addressing any deficiencies.
Santen completes Phase III testing of eye drug
NEW YORK Inspire Pharmaceuticals announced Friday a $1.25 million milestone payment from Japan-based company Santen Pharmaceutical for the completion of Phase III testing of the eye drug diquafosol tetrasodium, also known as DE-089. The two companies have a collaborative agreement to develop the drug.
DE-089 is designed to treat such eye-surface diseases as dry eye. Santen expects to file for marketing approval in Japan by June, and also plans to market the drug throughout Asia. Pending approval of DE-089 by regulatory agencies, Santen will market the drug while Inspire will receive royalties on net sales.
New York-based Inspire discovers, develops and commercializes ocular and respiratory drugs. Santen specializes in ocular and anti-rheumatic drugs and had headquarters in Osaka, Japan.
Salix receives FDA approvable letter for Balsalazide colitis treatment
RALEIGH, N.C. Salix Pharmaceuticals has received an approvable letter from the Food and Drug Administration for its ulcerative colitis drug Balsalazide Tablet NDA, the company announced May 16. The drug is designed to treat mild-to-moderate active ulcerative colitis in patients 18 years and older. The disease causes ulcers in the lining of the rectum and colon.
Salix has headquarters in Raleigh, N.C., and specializes in drugs to treat gastrointestinal disorders. The company markets such drugs as Colazal (balsalazide disodium) capsules 750 mg, Xifaxan (rifaximin) tablets 200 mg, Osmoprep (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) tablets and Moviprep (PEG 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution.