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

UsernamePublicRestriction

Enforce FD&C Act; Don't Stretch It

This article was originally published in RPM Report

Executive Summary

The new FDA senior leadership duo of Hamburg and Sharfstein are sending signs that they are ready to find some object lessons for high-visibility enforcement actions. A former FDA chief counsel and Just Department chief of staff warn that the agency should pict its targets carefully. Enforcing regulatory priorities instead of regulatory law can get the agency into difficult situations.

You may also be interested in...



Reacting to the CATT Study: Will Makena Make a Difference?

The long awaited head-to-head trial of Avastin vs. Lucentis in macular degeneration has finally reported results. It pits a $1,500 a dose therapy against a $50, unapproved alternative that most providers think is just as good. We just had that debate over Makena. Recent comments by FDA’s top drug review official suggest there may be another connection.

Margaret Hamburg: The Public Health Commissioner

An interview with newly confirmed FDA Commissioner Margaret Hamburg.

Let The Sunshine In: Health Care Reform Law Mandates Public Disclosure of Financial Ties Between Industry and Physicians

The "physician payments sunshine" provisions of the recently enacted health care reform legislation may chill relations between industry and physicians. They also are likely to impose significant costs on drug and device manufacturers.

Topics

UsernamePublicRestriction

Register

PS080578

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

Cancel