FDA rule would allow faster product safety information updates for generics
SILVER SPRING, Md. — When the maker of a branded drug updates the safety information on its product labeling, makers of generic versions of that drug must wait until the Food and Drug Administration approves the new labeling before they can update theirs, but that could soon change under a rule proposed by the FDA.
The agency said Friday that the proposed rule would allow generic drug makers to use the same process as branded drug makers to update safety information in the product labeling before the FDA had reviewed it, thus allowing faster dissemination of information to healthcare professionals and patients. Generic drug makers would be required to inform the manufacturer of the branded drug of the change, and the FDA would then evaluate whether the proposed change was justified and make a decision of whether to approve the change for the branded and generic drug maker at the same time.
"This proposal will help ensure that healthcare professionals and consumers have access to the latest safety information for the medications they use," FDA Center for Drug Evaluation and Research director Janet Woodcock said. "More than 80% of prescriptions filled in the U.S. are for generics, so we want to make sure that generic drug companies actively participate with the FDA to ensure that product safety information is accurate and up to date."
The Generic Pharmaceutical Association, a Washington-based trade group that represents generic drug companies, said it was in the process of reviewing the proposed rule.
“Patient safety is the foremost concern for manufacturers of generic medicines, which is why both brand and generic companies comply with federal law and strict FDA labeling rules and regulations," GPhA president and CEO Ralph Neas said. "Generic drug companies proactively participate with the FDA in ensuring the timeliness, accuracy, and completeness of drug safety labeling in accordance with current regulatory requirements, to ensure doctors and all healthcare professionals and patients have access to the most up-to-date information."
PharmaSmart, PDX technology integrate through new partnership
FORT WORTH, Texas — PharmaSmart’s kiosks will be integrated with PDX’s Enterprise Pharmacy System, allowing pharmacies with the EPS system to collect data from patients through the kiosks, under a partnership between the two companies announced Friday.
When patients opt-in, such clinical data as blood pressure and weight from the kiosks are recorded to their records in EPS and then to their centralized healthcare records stored in the Rx.com Enterprise Pharmacy Record. The integration will also allow notification of pharmacy staff when severe or urgent lab data indicate that intervention is required. The technology will be available in EPS in 2014, the companies said.
"PDX understands that pharmacies need tools to not only remain competitive in the marketplace, but also to drive patient outcomes," PDX president Brad Crosslin said. "By integrating this type of technology with EPS and facilitating the collection of clinical data within the patient’s healthcare record at the pharmacy and within the national [Enterprise Pharmacy Record], we are helping pharmacists take an even more thorough, direct role in the care of their patients."
Patients using the kiosk receive a smart card that links them to their individual PharmaSmart profile, and the integration of the two systems will give pharmacists access to an advanced clinical portal providing a comprehensive overview of the patient’s historical biometric data. This allows timely patient interventions, counseling sessions and increases medication therapy management and cognitive healthcare assessments for hypertensive, obese and diabetic patients.
Amneal to launch generic contraceptive
BRIDGEWATER, N.J. — Generic drug maker Amneal Pharmaceuticals will launch its version of a contraceptive product at the beginning of January, the drug maker said.
Amneal said it would launch its version of 24 Fe (norethindrone acetate and ethinyl estradiol tablets; ferrous fumarate tablets) in the 1 mg/20 mcg and 75 mg strength. As the first company to successfully file for Food and Drug Administration approval of the drug, Amneal’s product will have 180 days in which to compete exclusively against the branded version.
Loestrin 24 Fe had sales of $510.6 million during the 12-month period that ended in June 2013, according to IMS Health. The maker of branded Loestrin 24 Fe, Ireland-based Warner Chilcott, was acquired this year by Actavis.