Stay ahead of developments in federal and state health care law, regulation and transactions with timely, expert news and analysis.
Feb. 17 — The Food and Drug Administration will hold a public meeting March 27 on a proposed rule from 2013 on procedures generic drug companies would use to change their labels to reflect new safety information.
The meeting in the agency's White Oak office in Silver Spring, Md., will provide a public forum on the proposed rule on “changes being effected” supplements to labels that was published in November 2013 (78 Fed. Reg. 67,985, Nov. 13, 2013), the agency said in a notice set for publication Feb. 18 in the Federal Register.
The agency also is reopening the comment period (docket number FDA-2013-N-0500) on the proposal. Comments are due April 27. The agency said it is asking for comments on the proposal as well as on the “alternative proposals” presented during the March meeting.
In the notice, the agency said its proposed rule, “if finalized, would enable abbreviated new drug application (ANDA) holders for generic drugs to update product labeling promptly to reflect certain types of newly acquired safety-related information, irrespective of whether the revised labeling differs from that of the corresponding reference listed drug (RLD or brand drug)” upon submission of a changes being effected supplement to the FDA. The proposed revisions to allow generic manufacturers to update product labeling through CBE supplements “in the same manner as brand drug manufacturers are intended to improve communication of important, newly acquired drug safety information to health care professionals and the public.”
The proposed rule (RIN 0910–AG94) has been the subject of criticism from the generic drug industry and others, and the agency said in fall 2014 it was delaying the release of a final version until the end of September 2015.
In early 2014 comments to the FDA, generic drug manufacturers, pharmacists and drugstores said they have concerns with the agency's proposed generic drug labeling rule, including the possibility of additional litigation faced by makers of generic drugs. Meanwhile, consumer groups and patient advocates said the proposed rule would allow patients and health-care providers to have the most up-to-date safety information on generic products.
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to firstname.lastname@example.org.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to email@example.com.
Put me on standing order
Notify me when new releases are available (no standing order will be created)