CHPA, FDA discussing user fee program for OTC drugs
WASHINGTON — Since the Food and Drug Administration’s March 25, 2014 Part 15 public hearing on the OTC Drug Monograph, the Consumer Healthcare Products Association has been in discussions with FDA and relevant committees in Congress to identify potential enhancements that would update and modernize this regulatory framework for most nonprescription medicines.
"CHPA strongly supports the OTC Monograph System, but we believe that policy reforms could make the system more flexible, responsive and accommodating to innovation," the association noted in a press release issued Tuesday. "We recognize that resource constraints would affect the ability of FDA to implement any potential monograph reforms, and we are open to discussing ways of adequately funding reforms, including consideration of a user fee program for OTC drugs."
Following the FDA Public Meeting on OTC Monograph User Fees on June 10, 2016, CHPA has entered the stage of discussion that will include detailed talks about the parameters of a potential user fee framework.
Any such framework would require Congressional action. The FDA will post public minutes of these meetings on its website.
Protein Sciences: FDA approves 2016/17 formulation of Flublok
MERIDEN, Conn. – Protein Sciences Corporation on Tuesday announced that FDA has approved the 2016/17 formulation of Flublok influenza vaccine.
FDA approval of the 2016/17 formulation of Flublok means that Flublok is on track to ship to healthcare providers in early August.
"The timing of this approval could not be better. We will be able distribute Flublok earlier this season than before," stated Manon Cox, president and CEO of Protein Sciences Corporation. "In a surprise turn of events, CDC recently recommended against the use of FluMist vaccine that will result in a significant shortage of flu vaccines this season. Flublok is an excellent alternative for adults 18 and older."
This year FDA mandated two new components be made for trivalent flu vaccines, including a new H3N2 component that is also required for quadrivalent vaccines.
In a post-marketing clinical study of 9,000 adults 50 years and older during the 2014/15 flu season where H3N2 influenza was dominant, people who received Flublok were over 40% less likely to get cell culture confirmed influenza than people who received an egg-based flu vaccine, Protein Sciences reported.
Omron president, CEO joins board of HealthCorps, the organization founded by Dr. Oz
NEW YORK – HealthCorps, the national not-for-profit organization founded by Dr. Mehmet Oz and Lisa Oz, on Tuesday named Ranndy Kellogg, president and CEO of Omron Healthcare, to its board of directors.
Omron Healthcare is a world leader in heart and wellness technology and Kellogg is an outspoken advocate for heart health, advancing a vision of a world with zero heart attacks and strokes.
"Heart disease is the leading cause of death in the United States. But as we advance technology and education, it is feasible to make that statistic obsolete," Kellogg said. "HealthCorps has shown commitment and efficacy in establishing good habits in our nation's youth – a vital component in our mission to eliminate heart attack and stroke. I'm excited to take on a role with the organization to help us advance our shared goal of a healthier future."
Kellogg joins other influential members of the healthcare community on the HealthCorps board, which is chaired by HealthCorps founder Dr. Oz. Board members are committed to wellness advocacy at a national level, and support of HealthCorps' grassroots programs for young people that focus on fitness, nutrition and mental resilience.
"HealthCorps brings together leaders in public service and the private sector to make a meaningful difference," Dr. Oz said. "As a leader in the field of heart health and a passionate proponent of education and prevention of heart disease, Ranndy Kellogg, is a welcome addition to our team."
Omron Healthcare, has been developing heart monitors and studying patient behavior for 40 years, and is using that information to continually advance heart health technology. The company's emerging technology in the category is helping consumers collaborate with their physicians and take measureable real-time steps to avoid events and change their behavior. At the 2016 Consumer Electronics Show, Omron Healthcare showed its new Project Zero wrist and upper arm monitors that provide medical accuracy and convenient portability to effectively monitor heart health anytime-anywhere.
HealthCorps bestowed Golden Heart Honors on Omron Healthcare at the 2016 HealthCorps Garden Gala in May. Ranndy Kellogg was present to accept the award, which is given to organizations for outstanding efforts in promoting health and wellness among America's youth.
Prior to his work at Omron Healthcare, Kellogg served as VP and director of marketing for Baxter Healthcare. Before joining Baxter Healthcare, Kellogg held the position of group marketing manager at CR Bard. Kellogg holds a master's in business administration from Northwestern University's Kellogg School of Management.