NACDS weighs in on FDA priorities, urging simpler med info for patients
ALEXANDRIA, Va. The National Association of Chain Drug Stores is urging federal health officials to adopt a simpler means of communicating drug safety and efficacy information to patients, and to clear the way for an approval pathway for generic versions of biologically engineered drugs.
NACDS made its priorities known in a letter Monday to Margaret Hamburg, commissioner of the Food and Drug Administration. The letter came from Kevin Nicholson, the group’s VP government affairs and public policy.
NACDS, he told Hamburg, strongly endorses FDA efforts to adopt a simpler, single medication information document for patients in order to provide clear, easy-to-understand instructions and warnings about possible side effects, etc., of their prescription medicines. Such a document, Nicholson asserted, provides the “final link in the prescription supply chain,” and should be “standardized with respect to format and content.”
Behind that priority: the need to eliminate confusion and improve patient safety, NACDS agreed. “Today, patients receive several different types of written medication information, developed by different sources that may be duplicative, incomplete or difficult to read and understand,” Nicholson pointed out. “This current system is not adequate to ensure that patients receive essential medication information.”
The NACDS official reminded Hamburg that his group was part of a coalition of pharmacy groups that submitted a citizen petition to the FDA in 2008, urging the agency to require drug suppliers to provide “a concise, plain-language document for patients” when they fill a prescription.
Among the group’s other priorities with the agency: adoption of an abbreviated approval pathway for biogenerics. Nicholson also applauded recent efforts by the FDA’s Center for Drug Evaluation and Research and its director, Janet Woodcock, to address lingering skepticism among “certain sectors of the public” about the therapeutic equivalence of generic drugs.
“We applaud Dr. Woodcock for acknowledging this skepticism and for making its resolution a high priority,” he added.
Nicholson also addressed the issue of safety in the pharmaceutical supply chain, noting that NACDS has long supported state efforts to prevent the entry of adulterated or counterfeit drugs into the distribution pipeline. He urged the FDA to continue its stepped-up efforts to assure the integrity of the drug supply system by pursuing “developing global alliances of regulators, more inspections and updated technology systems to assist the agency with increased workload.
“Our industry has supported state-level legislation requiring enhanced wholesale distributor licensure requirements and chain-of-custody ‘pedigrees’ for drug distributions outside the recognized and sale ‘normal distribution channel,’” Nicholson told Hamburg. To that end, he added, “more than 60% of the states have enacted laws and regulations to strengthen the security for the drug distribution supply chain.”
FDA approves new treatment for bacterial infections
NEW YORK The Food and Drug Administration has approved a new treatment for bacterial infections made by Forest Labs, Forest said.
The drug maker announced the approval of Teflaro (ceftaroline fosamil) for the treatment of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infection, also known as ABSSSI, caused by bacteria that include methicillin-resistant Staphylococcus aureaus.
“Forest recognizes the enormous burden of disease associated with community-acquired bacterial pneumonia and [ABSSSI], and we are extremely pleased to see that our first product in this category has obtained approval for both of these disease indications,” said Dirk Thye, president of Forest subsidiary Cerexa.
Forest said it plans to make Teflaro available to wholesalers by January.
Adding to its clout in specialty care, McKesson wins bid for U.S. Oncology
SAN FRANCISCO In a big boost to its growing specialty pharmacy operation, drug-distribution and health services giant McKesson today revealed it has bought U.S. Oncology for $2.16 billion in cash and assumed debt.
Both companies said the deal should close by the end of McKesson’s third quarter on Dec. 31. When finalized, said company officials, it will merge McKesson’s strengths in healthcare services and information technology with U.S. Oncology’s expertise in clinical care, along with what it calls “the largest community-based cancer treatment and research network in America.” The combined organization, said McKesson, “will focus on providing a comprehensive offering of solutions for the oncology industry, one of the fastest-growing segments in healthcare.”
Following the merger, McKesson’s combined Specialty Care Solutions business will be led by U.S. Oncology CEO Bruce Broussard, who will report to McKesson executive VP and group president Paul Julian. The new operation will be based in The Woodlands, Texas, with additional offices in McKesson’s home city of San Francisco and other locations throughout the country.
It will deliver, in McKesson’s words, “a best-in-class oncology program, clinical tools, guidelines and care pathways that will create a leader in evidence-based medicine backed by a deep team of clinical experts.”
The new organization will initially serve a base of some 3,000 oncologists, spurring what the company said will be accelerated investments in integrated systems and clinical programs to boost productivity, efficient delivery of care and improved patient outcomes.
“For U.S. Oncology customers, they’re going to get a world-class distributor,” said McKesson chairman and CEO John Hammergren. “And for McKesson customers, they’re going to get a world-class oncology operations company.”
Hammergren called the acquisition “the next step in our involvement in oncology.”
“Clearly U.S. Oncology has a significant amount of technology, and has the world’s leading physicians using the world’s state-of-the-art thinking around clinical care,” he added. “They’ve driven efficiency in their practices, but perhaps more importantly, they’ve been leading the practice of health care from an oncology perspective.”
McKesson’s acquisition of the cancer-care giant will accelerate the consolidation of the specialty pharmacy market, predicted Adam Fein, PhD, founder and president of Pembroke Consulting. “After the U.S. Oncology acquisition, McKesson and AmerisourceBergen will now represent almost 80% of all specialty pharmaceutical distribution, which is the primary channel to market for office or clinic-based physicians,” Fein noted today.