FDA approves J&J anti-clotting drug
RARITAN, N.J. — The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating internal blood clots, the company said.
J&J subsidiary Janssen Pharmaceuticals announced the approval of Xarelto (rivaroxaban) for treating deep-vein thrombosis and pulmonary embolism and to reduce the risk of recurrence of the clotting conditions after initial treatment.
The company said Xarelto was the first oral anticoagulant approved to treat DVT and PE without the need for injections or routine blood-monitoring.
"Xarelto provides a single-drug treatment option from the moment of diagnosis through the completion of therapy, and in the initial treatment phase, it can cut a patient’s risk of major bleeding by nearly half," New York University School of Medicine professor Jack Ansell said. "Venous blood clots are associated with a high risk of serious complications, so the approval of Xarelto will immediately impact how we treat these patients and may set a new standard of care."
Rx Response mobilizes to help facilitate pharmaceutical distribution as East Coast rebuilds from Sandy
WASHINGTON — Rx Response, an initiative of America’s bio-pharmaceutical supply system to help ensure the continued flow of medicine to patients in a severe public health emergency, has continued its close coordination with federal, state and local government agencies to address impacts from Hurricane Sandy on the bio-pharmaceutical supply system, the organization announced Friday.
Rx Response officials remain in daily contact with senior officials at the Department of Homeland Security, FEMA and the Department of Health and Human Services, providing updates on Hurricane Sandy’s impact on the medicine supply chain.
A key focal point in the discussions between Rx Response and government agencies has been addressing challenges in getting fuel to delivery trucks re-supplying hospitals and pharmacies, and helping to secure fuel for pharmacies and other healthcare facilities operating on generator power. Efforts are currently underway to help ensure access to fuel for both delivery fleets and healthcare facilities powered by generators. Rx Response is also working with local law enforcement to help delivery vehicles gain access to areas impacted by Hurricane Sandy.
“We look forward to continuing our close coordination with Rx Response and government agencies to help ensure that our member companies can continue critical deliveries of medicine to hospitals and pharmacies,” stated Perry Fri, SVP industry relations, membership and education for the Healthcare Distribution Management Association, a member of Rx Response and the trade association representing primary healthcare distributors.
In addition, Rx Response also continues to update its Pharmacy Status Reporting Tool, an online program that allows emergency managers and the public to readily locate open pharmacies in communities that have been impacted by severe weather or other events at www.rxresponse.org. Many government agencies also have included links to the PSRT on their websites and in other communications.
“NACDS and its members appreciate the continued efforts by Rx Response to put patients first during this challenging time," stated Steven Anderson, president and CEO for the National Association of Chain Drug Stores. "In activating the Pharmacy Status Reporting Tool, Rx Response provided an incredibly important mechanism to help patients get the medicines they need from community pharmacies in the affected storm areas."
GDUFA-style user fees provide one possible source of funding for FDA compounding regulations
WHAT IT MEANS AND WHY IT’S IMPORTANT — Given the extent of the meningitis outbreak linked to a compounding pharmacy in Massachusetts, new regulations for such pharmacies might be a good idea, but how to implement them remains uncertain.
(THE NEWS: Meningitis outbreak linked to compounding pharmacy spawns new proposed legislation. Click here to read the story.)
One question that the bill — proposed by Rep. Ed Markey, D-Mass., to empower the Food and Drug Administration to regulate compounding pharmacies — appears to have left open was where the funding would come from for an agency that National Community Pharmacists Association SVP government affairs John Coster called "already stretched." The current makeup of Congress suggests that legislators may be reluctant to hand over more money to regulators, but some of the agency’s recent history provides clues of how it could get the funding and staffing. The reauthorization of the Prescription Drug User Fee Act that President Barack Obama signed into law earlier this year included the Generic Drug User Fee amendments, which call on the agency to collect user fees from generic drug makers so it can hire workers to inspect manufacturing plants in the United States and abroad.
According to the International Academy of Compounding Pharmacists, there are 7,500 pharmacies in the United States that compound, as well as 8,200 associated with hospitals and other health institution that also do. The compounding industry makes up 1% to 3% of the U.S. prescription market, but a national survey showed that 76% of independent pharmacists compound medications, in addition to virtually all home-health specialty pharmacies, hospital pharmacies and nuclear pharmacies. Needless to say, it’s a pretty large and widespread industry.
Whatever the case may be as far as the effectiveness of the current regulatory system for compounding pharmacies is concerned, the unsanitary conditions found at the pharmacy linked to the meningitis outbreak, the New England Compounding Center, show what can happen if the regulatory radar misses even one of them. According to Reuters, there is evidence that state and federal regulators were aware of problems at the NECC as early as 2002, and the FDA sent it a warning letter in 2006, but there was little evidence of a follow-up.
Regulations governing compounding pharmacies, particularly at the federal level, remain limited and fragmented, according to a report filed several days ago by Rep. Markey. For the moment, regulation happens mostly at the state level, through state boards of pharmacy. At the same time, the U.S. Pharmacopeia’s standards are integrated into the practice, and the Pharmacy Compounding Accreditation Board has national standards in place. While officials from the PCAB physically visit every compounding pharmacy seeking the organization’s accreditation, accreditation itself is not mandatory for any pharmacy that wants to compound medicines. The proposed legislation would help the FDA fill what Markey called a regulatory "black hole."
As of Friday, the meningitis outbreak linked to the NECC had resulted in 29 deaths and sickened 404 people in 19 states, according to the Centers for Disease Control and Prevention.