Watson sues FDA over generic Actos
PARSIPPANY, N.J. — Watson Pharmaceuticals is suing the Food and Drug Administration, alleging that an agency decision would improperly delay its release of a generic drug for diabetes, the company said Wednesday.
Watson said it was entitled to share market exclusivity for a generic version of Takeda’s Type 2 diabetes drug Actos (pioglitazone). Under the Hatch-Waxman Act of 1984, the first company to file a complete regulatory approval application with the FDA for a generic version of a drug is entitled to 180 days in which to compete exclusively with the branded version upon approval. In some cases, multiple companies share exclusivity, and a 2010 settlement with Takeda would allow Watson, Teva Pharmaceutical Industries, Mylan and Ranbaxy Labs to launch generic versions of Actos this Friday.
Watson said the FDA denied its claim of shared exclusivity based on the timing of its reinstatement of several of its original Paragraph IV certifications, a type of challenge to a branded drug maker’s patent commonly issued by generic drug companies. Watson said it had converted its Paragraph IV certification to a different type of challenge at the FDA’s direction, later reinstating the Paragraph IV certification after it settled a patent-infringement suit with Takeda. The FDA’s denial of Watson’s claim would delay its launch of the drug by six months, the company said.
"When we learned of [the] FDA’s position regarding our application, we made efforts to work cooperatively with [the] FDA to resolve the situation," Watson president and CEO Paul Bisaro said. "[The] FDA has refused to grant shared exclusivity and seeks to unnecessarily delay the launch of Watson’s generic Actos product, with potential harm to consumers who may face constraints on supply as a result of this action."
Actos had sales of about $2.7 billion during the 12-month period ended in May, according to IMS Health.
HHS partners with drug store chains to underscore Medicare benefits to seniors
WASHINGTON — The Department of Health and Human Services on Wednesday announced partnerships with several pharmacies to help customers learn about new Medicare benefits available to them under the Patient Protection and Affordable Care Act.
These partnerships — with CVS Caremark, Sam’s Club, Thrifty White, Walgreens and Walmart — will provide Medicare beneficiaries with a range of educational materials on newly available preventive services, as well as savings on prescription drug spending in the "doughnut hole" coverage gap.
At a CVS/pharmacy in Jacksonville, Fla., this morning, HHS secretary Kathleen Sebelius discussed the new preventive services and received a free blood-pressure reading at the store’s MinuteClinic. "Our pharmacy partners are helping their customers make informed healthcare decisions," Sebelius said. "These partnerships will help people with Medicare learn more about new preventive services, such as mammograms, and the new annual wellness visit that [is] available at no charge for everyone with Medicare."
Some examples of how pharmacy partners are working to increase awareness of preventive services available under Medicare include the following:
CVS Caremark is distributing material about new preventive services covered at no cost to beneficiaries at its more than 7,300 CVS/pharmacy stores and 600 MinuteClinic locations through brochures, register receipt messages and online;
Thrifty White Pharmacy is providing information on preventive services through its 85 locations throughout the Midwest;
Walgreens is distributing information in nearly 8,000 pharmacies and more than 350 Take Care Clinic locations, as well as using in-store announcements and providing this information as part of its Walgreens Way to Well Health Tour with AARP; and
HHS is working with Walmart and Sam’s Club to provide healthcare information to their shoppers online.
Other pharmacies or partners can find information on how to work with the Centers for Medicare and Medicaid Services to educate consumers about the benefits available to them here.
In addition, all Take Care Clinics located at select Walgreens locations now provide the "Welcome to Medicare" preventive visit and Medicare yearly wellness visits, Walgreens announced in a separate release. The Welcome to Medicare preventive visit and Medicare yearly wellness visits are wellness services for Medicare enrollees that include screenings for a number of common conditions, as well as education and counseling to encourage wellness and prevent disease.
According to CMS, only 6.5% of eligible seniors have used their Medicare wellness visit benefit. The benefit is available upon enrollment and then once a year with no out-of-pocket costs. With accessible locations inside more than 360 Walgreens and convenient seven-day-a-week hours, Take Care Health Systems can help remove barriers to healthcare access that may prevent Medicare enrollees from easily accessing care.
Take Care Clinics are professional healthcare centers located at more than 360 select Walgreens drug stores across the country, which offer walk-in and appointment availability. Board-certified family nurse practitioners and physician assistants treat patients ages 18 months and older for common illnesses; offer such preventive services as vaccines and physicals; and are licensed to write prescriptions, when necessary, that can be filled at the patient’s pharmacy of choice.
Patients can visit TakeCareHealth.com to schedule an appointment and to view local and up-to-date information on patient satisfaction scores, market-specific quality of care scores, wait times and service costs.
SoftSheen-Carson Magic Shave, actor Terrence J donate to nonprofit organization
NEW YORK — SoftSheen-Carson Magic Shave, a maker of African-American men’s shaving and grooming products, and actor and TV personality Terrence J donated $15,000 to the Steve and Marjorie Harvey Foundation at the 10th Annual Hoodies Awards on Aug. 4 in Las Vegas.
The donation was part of Magic Shave’s “Shave With A Purpose” campaign in conjunction with Terrence J and The Source.com.
For six weeks, Terrence J grew out his beard for the campaign. For every post, comment and upload to media partner The Source.com, proceeds benefitted the national organization dedicated to developing programs and supporting the needs of community-based organizations for African-Americans across the nation.