GPhA addresses Congress on economic impact of FDA’s proposed rule on prescription labeling
WASHINGTON — The Generic Pharmaceutical Association on Friday hosted a Congressional briefing highlighting the economic impact the Food and Drug Administration’s proposed rule on prescription labeling that would allow for label changes without prior FDA approval.
“By allowing label changes without prior FDA review and approval, the proposal will expose generic drug manufacturers to new liability that will drive up costs of generic drugs by at least $4 billion annually and, furthermore, may create confusion in the marketplace for patients, pharmacists and physicians," said Alex Brill, CEO Matrix Global Advisors. "The resulting cost increase will be borne by both consumers in the form of higher insurance premiums and the government in the form of higher Medicare and Medicaid costs.”
A recent report by Matrix Global Advisors estimated that U.S. healthcare costs would rise $4 billion annually if the proposed rule is enacted. Medicare and other government programs will incur $1.5 billion in annual new spending, while private insurers and patients will pay $2.5 billion per year.
“This proposal directly undermines the ‘sameness’ of generics and their brand counterparts — a fundamental scientific principle that is the very cornerstone of the success of generic medicines in the last thirty years,” stated Gordon Johnston, former deputy director, FDA Office of Generic Drugs. “The proposed rule paves the way for different versions of safety information for the same products, undermining the important principle of consistency. Disregarding decades of regulatory stability in this way will create unwarranted confusion, raises patient safety concerns and threatens the system that created thousands of affordable options for consumers. ”
Pharma industry calls on Congress to do more in the fight against counterfeit medicines
WASHINGTON — "The problem [of counterfeit medicines] is so big, disperse and complex that it requires a sweeping coordinated global response," wrote Scott LaGanga, executive director of the Partnership for Safe Medicines and SVP public affairs and advocacy for PhRMA in a blog published by The Hill on Saturday.
"According to the National Association of Boards of Pharmacy, 97% of all internet pharmacies do not meet the most basic criteria for accreditation," LaGanga wrote. "The reality is that all those emails clogging our inboxes from purported ‘Canadian’ pharmacies are often selling unapproved, counterfeit and potentially lethal medicines with no guarantees of the drugs being produced in Canada or other so-called ‘Tier One’ countries."
The blog follows a Congressional hearing on counterfeit medicines, held Thursday by the House Energy and Commerce Committee’s Subcommittee on Oversight and Investigations.
According to the Partnership for Safe Medicines, as many as 36 million Americans have purchased prescription medicines online without a prescription. Coupled with the fact that only 3-in-10 online pharmacies are legitimate, "that is, put very simply, a recipe for disaster," said Marv Shepherd, PSM president. "The bottom line is that criminal enterprises have been evolving and innovating at a faster pace than our government’s efforts to stop them, and that must change soon," he said. "As the worldwide prevalence of counterfeit drugs continues to increase, it is imperative that we work together to ensure that the prescription drug supply chain in the United States remains the safest in the world.”
"However, there [is] much more to be done, and that requires decision-makers at all levels of our government to work in public/private partnership with industry, patients and providers," LaGanga concluded in his blog. "With the rise of counterfeit medicines as a booming global industry, there is simply too much at stake for patient health to ignore the issue any longer."
Diplomat Pharmacy hosts college students as part of Alternative Spring Break program
FLINT, Mich. — Diplomat Pharmacy on Friday announced it will be hosting college students from across the nation this week. Students from as far away as New Mexico State will be participating in an expanded version of Diplomat’s Alternative Spring Break program that kicked off Monday.
Also serving with New Mexico State will be students and staff members from Michigan State, Virginia Tech and the University of Michigan-Ann Arbor.
Alternative Spring Break is a nationwide program that offers community service-learning experiences during the traditional college spring breaks, according to Steve Wolbert, Diplomat’s director of community relations and government affairs. The students have spent months learning about the culture and history of Flint, and once they arrive, they will be immersed in the community with experiential learning opportunities and direct service to non-profits.
The program also includes group discussions, readings and reflection activities at a selected site to engage in meaningful action toward a greater understanding of root causes of relevant issues.
Diplomat is the primary facilitator between the students and various community organizations in the Flint area. Wolbert said that as they enter the fifth year of the program, they continue to look for key indicators that the program is successful.
Activities for their respective weeks in Flint will include city tours; working with Genesee County Habitat for Humanity, Carriage Town Mission, St. Luke N.E.W. Life Center, North End Soup Kitchen and Boys & Girls Club of Greater Flint; and assisting Kettering University with a neighborhood cleanup of the Mott Park area. Each morning students will work with various community organizations in the Flint area. Afternoons will be spent volunteering at local schools working and tutoring students. ASB students will hear from local community leaders from the non-profit, government and business sector during dinner each evening.