FDA OKs Aurobindo’s generic version of top-selling Parkinson’s drug
Dayton, N.J. — Aurobindo Pharma Limited has announced that it has received final approval from the U.S. Food and Drug Administration for entacapone tablets USP, 200 mg, the generic equivalent to Comtan Tablets 200 mg.
Comtan, which is used in the treatment of Parkinson’s disease, was one of Novartis’ top 20 top-selling drugs in 2014, with sales totaling $371 million.
Groups push FDA for delay on Track and Trace regulations
ALEXANDRIA, Va. — Pharmacy organizations, including, The American Pharmacists Association, National Alliance of State Pharmacy Associations and National Community Pharmacists Association, called on Food and Drug Administration officials to delay enforcement of a July 1 electronic product-tracing deadline for prescription drug dispensers, to “help avoid any potential disruptions in the pharmaceutical supply chain,” the groups noted in a joint letter to FDA.
“With the December, 2014 FDA enforcement discretion delaying enforcement of the product tracing requirements until May 1, 2015, this implementation timetable has been compressed,” the groups wrote in a June 22 letter to FDA deputy director, office of compliance, Dr. Ilisa Bernstein.
“Our organizations remain concerned that despite the extensive efforts by pharmacy and wholesale distributor associations to educate dispensers, some trading partners will encounter challenges beyond their control, with the possible outcome of disruptions in the supply chain,” the letter said. “In order to forestall potential disruptions in the pharmaceutical supply chain, the undersigned organizations respectfully request that FDA utilize its enforcement discretion to delay the July 1 product-tracing deadline for dispensers. Our members fully intend to continue intense, concerted efforts toward full compliance, but by exercising its enforcement authority, FDA would allow progress to continue while minimizing the risk of product shortages or disrupting patient access to prescription drugs.”
To read the full letter, click here.
Oregon gov. signs legislation to expand access to pharmacists’ patient care services
WASHINGTON — Earlier this month, Oregon Governor Kate Brown signed landmark legislation into law that helps expand patient access to pharmacists' patient care services. The legislation, HB 2028, which passed with overwhelming bipartisan support, permits insurance carriers to add pharmacists to its network of providers and expands existing laws related to collaborative drug therapy management among other wins.
Through the legislation, patients will have access to the specialized care services pharmacists provide including medication management, disease prevention and wellness and post-diagnostic disease management. Pharmacists and doctors will now be able to work together to design and implement collaborative agreements to increase access to pharmacists’ patient care services and improve patients’ health.
“We applaud the state legislators in Oregon for recognizing that the future of health care is about access, quality and team-based care, and congratulate the Oregon State Pharmacy Association for their tireless work on this effort,” American Pharmacists Association EVP and CEO Thomas E. Menighan said in response to the move. ”This transformative legislation will improve patients’ access to patient care from pharmacists while also allowing for greater collaboration among health care providers, both of which will result in improved patient outcomes.”
Overt inclusion of pharmacists on the health care team continues to gain momentum across the country, as California and Washington recently passed similar legislation.
In late January, the Pharmacy and Medically Underserved Areas Enhancement Act was introduced in both the House of Representatives (H.R. 592) and Senate (S. 314). Passage of this legislation is a critical step in better utilizing pharmacists to positively impact patients and health care. Today, there are 145 bipartisan co-sponsors on the House bill and 19 co-sponsors on the Senate bill.
“APhA and the Patient Access to Pharmacists’ Care Coalition, a coalition of more than 30 organizations representing patients, pharmacists, and pharmacies, as well as other interested stakeholders, urges members of Congress to take steps now to improve Medicare beneficiary access to health care services through pharmacists and their services,” Menighan added. “As highly accessible and educated health care professionals, pharmacists are in a position to improve quality of care and patient outcomes, especially for those patients living in medically underserved areas.”