FDA approves generic versions of Aciphex
SILVER SPRING, Md. — The Food and Drug Administration has approved six generic versions of a drug used to treat gastroesophageal reflux disease, or GERD, the agency said Friday.
The FDA announced the approval of the first generic versions of Eisai’s Aciphex (rabeprazole sodium) delayed-release tablets for patients aged 12 and older. The generic products are made by Dr. Reddy’s Labs, Kremers Urban Pharmaceuticals, Lupin Pharmaceuticals, Mylan Pharmaceuticals, Teva Pharmaceuticals USA and Torrent Pharmaceuticals.
"Healthcare professionals and consumers can be assured that FDA-approved generic drugs have met the same rigid standards of quality as the brand-name drug," FDA Office of Generic Drugs acting director Kathleen Uhl said. "This medication is widely used by people who have gastroesophageal reflux disease, so it is important to have access to affordable treatment options."
Supporting OTC purchases through FSAs saves money in two ways — saved taxes and reduced premiums
The Senate this past week heard legislation that would reverse the provision of the Patient Protection and Affordable Care Act mandating a prescription on the sale of an over-the-counter medicine being paid for through a flexible spending account. All those in the retail pharmacy industry are staunch supporters of the legislation.
And that’s because retail pharmacy gets it. It’s not about the sales — has anyone ever heard of a consumer who decided not to purchase a pain reliever or cough syrup because it wasn’t an eligible FSA purchase without a trip to their doctor? No. That person doesn’t exist — they’ll buy the same amount of OTCs to cure what’s ailing them with an FSA as without an FSA. No, it’s about the value inherent within OTCs. It’s about tapping into that value to the benefit of both consumers and overall health care.
Almost 1-in-6 Americans participate in an FSA, so the savings impact to the consumer will be real.
Supporting OTCs as a first line of treatment makes sense for healthcare providers, too. OTCs provide $102 billion in savings to our nation’s healthcare system every year — $3 of every $4 by way of reducing doctor visits and $1 of every $4 by way of dispensing fewer medicines. And nearly one-third of the $102 billion in annual savings is for consumers treating cough-cold and flu symptoms.
For every $1 spent on OTC medicines, the U.S healthcare system saves as much as $7.
And that’s the real win. Because reduced healthcare costs for payers means lower healthcare premiums, or at least premiums that don’t increase year over year at such a sharp rate.
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."