President Trump signs OTC Hearing Aid Act into law
WASHINGTON — Hearing aids addressing mild to moderate hearing loss are soon headed to a retail pharmacy near you. President Donald Trump last week signed into law the "FDA Reauthorization Act of 2017," which included the bipartisan Over-the-Counter Hearing Aid Act.
"The House and Senate passed this measure recently as part of the FDA Reauthorization Act with overwhelming bipartisan support," stated Rep. Marsha Blackburn, R-Tenn. "And on Friday, the President signed this landmark bill into law. For so many, this measure will finally make hearing correction affordable and within reach – with the latest technology, competitive prices and a short trip to your local pharmacy or shopping center," she suggested. "This bill addresses a problem that does not discriminate. At older ages, hearing loss becomes almost universal, affecting more than 60% of those in their 70s and nearly 80% of those over 80."
“I’ve heard from Iowans and others around the country in support of this provision,” added Sen. Chuck Grassley, R-Iowa, a co-sponsor of the legislation in the Senate. “Consumers are interested in new hearing aid products to improve their quality of life at an affordable price. The more products available, the more consumers will be able to find something they can afford that works for them.”
"Thanks to President Trump signing the FDA Reauthorization bill into law … consumers with mild-to-moderate hearing loss will no longer be at the mercy of companies selling expensive and cost-prohibitive hearing aids that cost thousands of dollars," commented Gary Shapiro, president and CEO, Consumer Tehcnology Association. "Instead, 40 million Americans living with hearing loss in the future can buy over-the-counter hearing aids at roughly one-tenth of what traditional hearing aids costs."
Now the real work begins, Shapiro suggested, as stakeholders including CTA work with FDA on quality-assurance measures that will enable the consumer to distinguish high-quality hearing enhancement devices for mild-to-moderate hearing loss from cheap, ineffective personal amplifiers.
According to CTA research, 1.5 million devices designed to amplify ambient sounds are expected to be sold in the U.S. this year.
Caret Pharma grows footprint with Fiber Choice acquisition
BOCA RATON, Fla. — Caret Pharma today announced it has entered into an agreement with Moberg Pharma to acquire the assets of Fiber Choice, a line of dietary supplements containing 100% natural, prebiotic fiber.
Fiber Choice will be marketed by IM HealthScience, a subsidiary of Caret Pharma’s parent company, Caret Group. It will join a growing digestive health product portfolio that already includes IBgard (for irritable bowel syndrome) and FDgard (for functional dyspepsia).
“We are pleased to welcome Fiber Choice to our family of companies. In a time of consumer empowerment and rising healthcare costs, people are taking a more active role in managing their own health-and-wellness. We believe Fiber Choice offers these consumers and their healthcare providers an important option,” said Fred Hassan, founder and chairman of Caret Group.
Perrigo prepping launch of Nexium 24HR equivalent following FDA OK
DUBLIN — Perrigo today announced that it has received final approval from the U.S. Food and Drug Administration for its store brand OTC equivalent of Nexium 24HR (esomeprazole magnesium) capsules.
The company also announced that it has reached a settlement of patent litigation with AstraZeneca, allowing for its store brand capsules to launch at the end of next month. The OTC Nexium 24HR equivalent will be packaged and marketed as a store brand or retailer own label brand. Nexium 24HR capsules are indicated to treat heartburn that occurs two or more days a week. Approximate annual retail sales for the last 12 months were in excess of $300 million.
“This final approval and upcoming launch demonstrates the tremendous capabilities of our leading store-brand OTC platform,” said Perrigo EVP and president of Consumer Healthcare Americas Jeff Needham. “We are eager to finalize launch plans with our retail and wholesale partners to bring this major new product to consumers. Important product launches like the store brand equivalent of Nexium 24HR capsules are what drive the Perrigo advantage by providing our customers with high quality, value alternatives in important treatment categories."