FDA approves new labeling for OxyContin
SILVER SPRING, Md. — The Food and Drug Administration will not approve generic versions of Purdue Pharma’s painkiller OxyContin based on earlier versions of the drug that did not include features to thwart abuse, the agency said Tuesday.
The FDA announced that it approved updated labeling for reformulated OxyContin (oxycodone) extended-release tablets indicating that it has physical and chemical properties designed to deter drug abusers from crushing or dissolving the pills in order to inject or snort them.
Also, because the original version of OxyContin did not include abuse-deterrent features, the FDA said it would not approve generic versions of that version, which has been withdrawn from the market. The FDA approved the original version of OxyContin in 1995 and the abuse-deterrent version in April 2010; Purdue stopped shipping the original version in August 2010.
The approval of the new labeling comes on the same day as the expiration of OxyContin’s patent protection and amid fears that future generic versions of the drug will lack the anti-abuse features of the branded version. OxyContin has long been a drug of choice for drug abusers and a major target for theft. According to the Substance Abuse and Mental Health Administration, about 500,000 people aged 12 and older became new abusers of the drug in 2008.
"The development of abuse-deterrent opioid analgesics is a public health priority for the FDA," FDA Center for Drug Evaluation and Research deputy director for regulatory programs Douglas Throckmorton said. "While both original and reformulated OxyContin are subject to abuse and misuse, the FDA has determined that reformulated OxyContin can be expected to make abuse by injection difficult and expected to reduce abuse by snorting compared to original OxyContin."
The Generic Pharmaceutical Association, a trade group that represents generic drug manufacturers, heralded the FDA’s announcement.
“We share the Agency’s goal of addressing prescription opioid abuse, and using a science-based approach to take on this complex problem," GPhA president and CEO Ralph Neas said. "At the same time, we recognize the importance of balancing patient access to medicine with efforts to minimize abuse. Yesterday’s decision from the FDA provides clear guidance on what is considered an abuse-deterrent formulation for OxyContin, information that GPhA and its member companies have been seeking since 2010."
Sam’s Club offers free oral health screenings
BENTONVILLE, Ark. — Sam’s Club offered free oral care and health screening events at all 564 of its stores that have pharmacies, the club retailer said.
Sam’s Club, owned by Walmart, said the events, which took place on Saturday, included non-invasive oral health questionnaires, dental tablets, glucose, total cholesterol, blood pressure, body-mass index and vision tests.
According to WebMD, oral health issues are often identifiers of diabetes and heart disease.
"Every year, approximately 100 million Americans fail to visit a dentist," Sam’s Club SVP health and wellness Jill Turner-Michael said. "Free oral health and wellness screenings at Sam’s Club provide useful reminders that oral health issues may be symptoms of more serious chronic diseases."
NABP hopes to curb rogue pharmacies with ‘.pharmacy’ Web domain
MOUNT PROSPECT, Ill. — Amid various strategies adopted to stop the proliferation of rogue online pharmacies, one group has proposed controlling what they can put at the end of their Web addresses.
The National Association of Boards of Pharmacies said it would create a generic top-level domain, .pharmacy, that only legitimate online pharmacies could use. Top-level domains are the suffixes at the end of Web addresses that determine what type of organization owns the site, such as .com for commercial enterprises, .org for non-profit groups, .gov for government agencies and so forth.
The NABP said it had formed partnerships with international regulators, pharmacy organizations and law enforcement organizations in the effort. The group said it applied for the .pharmacy domain in June of last year and submitted its application as part of ICANN’s expansion of available domains. It expects ICANN’s review process for the domain to be released by this summer.
"The ultimate benefactors of NABP’s vision for this new [generic top-level domain] will be the healthcare community and patients worldwide, who will be assured that all pharmacy sites ending in the .pharmacy gLTD are safe and legitimate," NABP president Michael Burleson said. "By vetting .pharmacy registrants for compliance with international standards, NABP seeks to protect patients worldwide from the health risks that can result when drug sellers circumvent supply-chain safeguards."
Rogue internet pharmacies have become a growing problem as many patients in the United States, seeking a bargain on prescription drugs, will order their medications from them. The pharmacies will go to great lengths to disguise themselves as Canadian or American, but are often operated from countries with lax regulations. The problem is that the drugs they sell may be counterfeit, adulterated, expired or contaminated. A January review by the NABP of 10,275 online pharmacies found that 97% of them were out of compliance with U.S. laws. Of the 9,938 identified as "non-recommended," nearly half offered drugs to U.S. residents that were foreign or not approved by the Food and Drug Administration, as well as selling dangerous counterfeit drugs.