CHPA names new president
WASHINGTON Scott Melville now is at the helm of the Consumer Healthcare Products Association.
CHPA said Tuesday that Melville, who currently serves as SVP government affairs and general counsel for the Healthcare Distribution and Management Association, will succeed Linda Suydam as president, who is retiring after eight years with CHPA.
Melville brings more than two decades of healthcare, legislative, regulatory and association management experience to his new role as CHPA president. Prior to joining HDMA, the national association representing pharmaceutical wholesale distributors, Melville served as an attorney and head of government relations for Cephalon.
“I am extremely honored to join CHPA at this critical time and to build upon the many accomplishments realized under Linda Suydam’s leadership,” Melville said. “I look forward to working with the CHPA board and the entire membership to further advance the essential contribution that [over-the-counter] medicines and dietary supplements offer to millions of American consumers seeking safe, effective and convenient healthcare remedies.”
Biosimilars’ future predicted to be as uncontroversial as generics
NEW YORK —Biosimilars, biogenerics, follow-on biologics—whatever the designation one prefers for knockoffs of biotech drugs—they will soon become a part of the American healthcare system.
The healthcare-reform bill contained a provision creating an abbreviated regulatory approval pathway for follow-on biologics—albeit one that requires the Food and Drug Administration to wait until the innovator biologic has been on the market for 12 years before approving the follow-on version, rather than the five-year market exclusivity period used for generic pharmaceutical drugs.
Of particular interest is the case of Lovenox (enoxaparin sodium), a form of the blood thinner heparin, and the marketing of a generic version by Sandoz, which manufactures the drug under a partnership with Momenta Pharmaceuticals. Sandoz, the generics division of Swiss drug maker Novartis, won approval from the FDA to market generic Lovenox in July, and Sanofi sued to halt Sandoz, saying the FDA had acted improperly in granting approval, but a federal judge ruled in favor of Sandoz and the FDA. The catch is that though Lovenox received FDA approval in March 1993 as a pharmaceutical, many experts consider it a biologic due to its chemical complexity, and the FDA required testing for potential issues like allergic reactions before it would approve the generic version. For that reason, many experts said, the case of generic Lovenox could have a major influence on the regulatory approval process for follow-on biologics.
But after the market does take shape, it could eventually look increasingly more like the generic drug market, director Michael Malecki of industry research firm Decision Resources told Drug Store News. Malecki expected follow-on biologics’ initial effect on pricing to be small, at least until biosimilar monoclonal antibodies begin reaching the U.S. market, but that the market will take off over the next decade. “Over the next 10 or so years, we will be seeing a lot of marketing on the part of branded and biosimilar companies trying to shape the landscape,” Malecki said. “Biosimilar companies will claim that their products are just as safe and effective as brands, and some brands will try to counter that argument.”
In around 20 years, Malecki said, biosimilars could be as uncontroversial as generic drugs. “At some point in the future, biosimilars will be regarded analogously to small-molecule generics,” he said. “The questions are how long that change will take and what will be the ‘shape of the curve’ between now and then.”
In the meantime, some companies aren’t waiting and are seeking approval for biosimilars under the normal approval process. In February, for example, the FDA accepted Teva Pharmaceutical Industries’ application for XM02, a biosimilar of Amgen’s Neupogen (filgrastim) that it already markets in Europe under the name TevaGrastim. Teva is seeking approval for the drug as a treatment for lowered counts of white blood cells called neutrophils, also known as febrile neutropenia, in patients receiving chemotherapy.
NACDS Pharmacy & Tech Conference offers manifesto of pharmacy’s value
SAN DIEGO —If ever there was a time for retail pharmacists to assert their role and ride to the rescue of a broken healthcare system, that time is now.
That, in essence, was the dominant theme of the National Association of Chain Drug Stores’ 2010 Pharmacy and Technology Conference here. NACDS leaders urged the hundreds of pharmacy retailers, suppliers and guests who attended the 53rd annual pharmacy event to press their case, both locally and nationally, for a larger stake in the healthcare system and fair reimbursement for a steadily growing list of health-and-wellness services by pharmacists.
“We must define the value for pharmacy in a reformed healthcare delivery system,” said NACDS chairman and CVS Caremark president and COO Larry Merlo at the conference’s opening business session Aug. 29. “We’ve identified several areas where pharmacy is in the best position to effectively and positively contribute to all three pillars of that healthcare equation: access, quality and cost. But most important of all, we must ensure that the value of the pharmacy industry, and its pharmacists, [is] recognized by payer reimbursement policies—not just for the products we sell, but for the services we provide.”
The healthcare system, said industry leaders at the four-day event, is in a state of crisis and will demand the kinds of cost-effective, patient-focused solutions that retail pharmacies can provide. Indeed, said NACDS president and CEO Steve Anderson, retail pharmacy is going through a “historic paradigm change” as pharmacists and pharmacy leaders expand their patient care and clinical capabilities, and provide new solutions to a “broken” healthcare system undergoing rapid change. That change, he told attendees, would usher in a “renaissance” in how pharmacy is practiced and how pharmacists collaborate with other healthcare professions. “We need to build a case for a modern and viable reimbursement system” that takes into account pharmacy’s contributions to health and cost-effectiveness, Anderson asserted.
On the show floor
To that end, Anderson announced the launch of a new component of the bipartisan grassroots lobbying campaign, dubbed RxIMPACT Votes! “This is what political professionals refer to as a get-out-the-vote campaign,” he explained. “It encourages NACDS member company staff to register to vote, encourages them to volunteer for political campaigns of their choosing and then inspires them to vote on Election Day.”
The pharmacy gathering, which concluded Aug. 31, provided a packed schedule of information-sharing sessions and educational seminars, and showcased a host of new products and solutions for pharmacy retailers.