Indiana Senate passes generic biologic pathway legislation
WASHINGTON — The Biotechnology Industry Organization and the Indiana Health Industry Forum on Thursday commended the Indiana Senate for passing legislation designed to create a pathway for the substitution of interchangeable biologic medicines.
The policies outlined in the identical SB 262 align with BIO’s principles on biologic substitution, therefore BIO and IHIF support passage of this bill as it moves along for consideration by the Indiana House of Representatives.
Although similar bills have been addressed in other states, SB 262 enjoys the support of a broad coalition of both biologic and biosimilar manufacturing companies. This bill includes transparent communication on all biologic medicines dispensed in order to maintain a consistent and complete medical record. This legislation represents a significant step forward and ensures transparency and communication between patients and their treatment teams.
While the Food and Drug Administration oversees approval of biologic medicines and designation of interchangeability, policies governing whether one product may be substituted in place of a doctor’s prescription and whether a pharmacist must inform patients and doctors are covered by state law. SB 262 seeks to properly preserve patient access to accurate prescription information, maintain incentives for innovation and promote a competitive market for biologic therapies.
Bills such as this that properly address the important aspect of physician communication represent model legislation necessary in all 50 states to address this cutting-edge technology, BIO said.
The FDA currently is developing a pathway for the development and approval of safe and effective interchangeable biologic products in the United States. However, there is still a major role for states to play in ensuring substitution practices remain transparent and physicians remain engaged in the process, BIO noted.
Novo Nordisk announces new SVP
PRINCETON, N.J. — Global healthcare company Novo Nordisk announced the promotion of Eddie Williams to SVP biopharmaceuticals, effective Feb. 1, 2014.
"Our biopharmaceutical business will be increasingly important to our growth in the U.S. as we apply the protein expertise developed through our diabetes franchise to helping people with hemophilia and growth disorders manage their conditions more effectively," Jesper Hoiland, president of Novo Nordisk, the company’s U.S. affiliate, said. "That business has flourished under Eddie’s experienced leadership. His promotion to senior vice president demonstrates the company’s focus on, and commitment to, our pipeline of life-changing biological therapies."
Williams joined Novo Nordisk in 2006 and currently serves as corporate VP biopharmaceuticals, a role in which he leads the sales and marketing, business development and new product commercialization functions for the company’s growing U.S. biopharmaceuticals business.
GPhA pays homage to retiring Rep. Henry Waxman
WASHINGTON — Following the announcement that Rep. Henry Waxman, D-Calif., intended to retire, the Generic Pharmaceutical Association on Thursday bid adieu to a legislator who had a tremendous positive impact on the generic industry.
“The contributions of this extraordinary leader, master legislator and passionate advocate for patient access to affordable medicines have positively impacted the lives of millions of American consumers," noted Ralph Neas, GPhA president and CEO. "As the co-sponsor of the 1984 Drug Price Competition and Patent Term Restoration Act, commonly referred to as Waxman-Hatch, Rep. Waxman led the creation of the modern generic drug industry, which continues to flourish today. The extraordinary success of this law, which balances competition and innovation, makes it possible for millions of patients and consumers to have access to more affordable generic medicines," he said. "In the last decade alone, this landmark legislation enabled $1.2 trillion in patient and health system savings."
Waxman was also instrumental in the passage of the Drug Quality and Security Act, which established a predictable, reliable national standard for electronic prescription medicine tracking, Neas added.