Regulatory and Washington

WASHINGTON — In anticipation of the March 13 deadline for comments on the FDA's proposed rule on prescription generic drug labeling, 21 health industry groups submitted a new letter to the agency on Thursday, raising concerns about the proposed regulation. 

WASHINGTON — The administration is seeking $4.7 billion for the Food and Drug Administration, representing a 6.8% increase, according to a report published Tuesday by the Washington Post. 

According to the report, the budget includes $25 million to register and inspect large-scale compounding pharmacies.

WASHINGTON — In what could turn into a significant change of how retail pharmacy supplies hydrocodone combination products, the Drug Enforcement Administration last week published in the Federal Register a Notice of Proposed Rulemaking to move HCPs from Schedule III to Schedule II, as recommended by the assistant secretary for Health of the department of Health and Human Services and as supported by the DEA’s evaluation of relevant data.  

ATLANTA — Most people who abuse prescription opioid drugs get them for free from a friend or relative — but those at highest risk of overdose are as likely to get them from a doctor’s prescription, Centers for Disease Control researchers reported Monday in a research letter, “Sources of Prescription Opioid Pain Relievers by Frequency of Past-Year Nonmedical Use: United States, 2008-2011,” in the Journal of the American Medical Association Internal Medicine.

WASHINGTON — The Generic Pharmaceutical Association on Friday hosted a Congressional briefing highlighting the economic impact the Food and Drug Administration’s proposed rule on prescription labeling that would allow for label changes without prior FDA approval.

WASHINGTON — "The problem [of counterfeit medicines] is so big, disperse and complex that it requires a sweeping coordinated global response," wrote Scott LaGanga, executive director of the Partnership for Safe Medicines and SVP public affairs and advocacy for PhRMA in a blog published by The Hill on Saturday.

SILVER SPRING, Md. — The Food and Drug Administration last week ruled that generic equivalents to Teva Pharmaceutical's Plan B emergency contraceptive can be sold alongside Plan B without any behind-the-counter merchandising restrictions or a requirement to verify the age of the purchaser in a letter to the interested parties. 

WASHINGTON — Last week, more than 30 organizations  — including the American Medical Association, Infectious Diseases Society of America and Pew Charitable Trusts — urged Congressional leaders to strengthen the labeling requirements for drugs approved under the proposed Antibiotic Development to Advance Patient Treatment Act of 2013 (ADAPT Act) limited population approval pathway, which will streamline regulatory approval for antibiotics.