Regulatory and Washington

WASHINGTON, D.C. — Walmart has joined almost two-dozen organizations from across the healthcare supply chain in a letter calling on the Food and Drug Administration to consider the public health impact of its Proposed Rule on pharmaceutical labeling.

ARLINGTON, Va. – Citing pharmacist-administered medication therapy management, recognition of pharmacists as healthcare providers, the need for fair and accurate pharmacy reimbursement in state Medicaid programs and other pharmacy services, the National Association of Chain Drug Stores has sent a statement to lawmakers urging them to consider pharmacy provisions within the “Fiscal 2015 Budget,” released by the administration last week.

ARLINGTON, Va. — Bipartisan legislation that would designate pharmacists as healthcare providers under the Medicare program was introduced in the U.S. House of Representatives on Tuesday. The bill would amend The Social Security Act of 1935 to enable pharmacists to work to their full capability by providing underserved patients in the Medicare program with services not currently available to them.

WASHINGTON — The Centers for Medicare and Medicaid Services has decided not to move forward on several of the proposed provisions of the Medicare Advantage and Part D prescription drug program, according to reports.

NEW YORK — The majority of pediatric bacterial infections that cause severe diarrhea and are potentially life-threatening occur among children who recently took antibiotics prescribed by doctors for other conditions, according to a new study by the Centers for Disease Control and Prevention published this week in Pediatrics.

Two Rx-to-OTC switches in the past year may serve as a harbinger of what the Food and Drug Administration will consider “switch” worthy. They both address chronic care needs, and they both represent first of their kind medicines to the nonprescription aisle.

WASHINGTON — A Maryland bill that is intended to help pharmacies in managing inventories and avoid potential drug shortages could create hardships for distributors, according to an FDA law blog.

Although the United States is still waiting for final practical guidelines from the Food and Drug Administration about the launch of biosimilars and the standards required to meet the threshold of interchangeability, the rest of the world seems to be barreling forward with the development and launch of these important medicines. By the end of this decade, a significant number of blockbuster drugs will go off patent, paving the way for biosimlar market entrance.