Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



Executive Summary

UPSHER-SMITH URGES GENERIC APPROVAL REVIEW BOARD be established by FDA, consisting of agency and industry representatives, as a way to improve communications between the groups. The Minneapolis company suggested the creation of the board to function as an ombudsman and prevent a repeat of the type of concerns about favoritism and the opportunities for favoritism that precipitated the recent investigations of FDA's generic review effort. Upsher-Smith suggested that a review board could "meet every two-three months and act like an ombudsman to openly discuss any specific problems or complaints...and develop responses to the concerns." The need exists, Upsher-Smith said, "for improved and increased communication between FDA staff and industry representatives." The main areas of missed communications, the company indicated, "include communications regarding the status of an application and the accessibility of reviewers to answer questions about the application." The board could also "publish a monthly report which would cover the issues discussed and the responses to each concern." Similarly, Lederle recommended that the Office of Generic drugs establish a system under which companies can appeal FDA decisions. "FDA should set up a mechanism for handling appeals by ANDA holders and applicants who disagree with FDA's interpretation or implementation of laws or regulations." Lederle added that "fear of retaliation is still an industry concern." Barr Labs, one of the most vocal of the firms criticizing previous ANDA procedures, advised the agency in comments that FDA "must improve the fairness of generic drug review policies and procedures." Suggestions for a level playing field include proper management of submitted information, consistency in its decisions, and establishment of standards for finding whether approvals or bioequivalence determinations can be withdrawn retroactively. The Pharmaceutical Manufacturers Association stated, in its comments, that "the single most important administrative requirement for the responsible management of the Generic Drug Program is close and careful monitoring of the review process by FDA senior staff." The association continued: "In order to effectively monitor the system, there must be a tracking system in place that will allow supervisory personnel to identify aberrations in the process of review and approval." PMA also suggested that Summary Basis of Approvals should be generated for generic drug approvals so that "any member of the public can obtain a document describing the review leading to approval and examine the scientific basis for such action."

You may also be interested in...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts