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
UsernamePublicRestriction

FDA INTERPRETIVE RULES NOTICE-AND-COMMENT REQUIREMENT

Executive Summary

FDA INTERPRETIVE RULES NOTICE-AND-COMMENT REQUIREMENT should be retained because it gives industry the opportunity to provide its view as well as more time to make changes needed to comply with new agency policies, the Pharmaceutical Manufacturers Association recommended in Sept. 27 written comments to FDA. "Current procedure enhances the regulatory process by allowing the open expression of all points of view prior to the establishment of agency policies," PMA suggested. "While the agency has a very high level of expertise on food and drug matters, it can still benefit from input from regulated industries and other members of the public." The federal Administrative Procedures Act requires agencies to follow formal rulemaking procedures for rules that implement or proscribe law. The APA exempts interpretive rules, rules of agency practice and general statements of policy from that requirement. In 1975, FDA waived the exemption and said it would follow an informal notice-and-comment requirement for interpretive rules. In the July 31 Federal Register, FDA proposed to rescind that waiver and no longer require notice and comment ("The Pink Sheet, Aug. 13, T&G-13). PMA also observed that FDA has previously "recognized the difficulty in distinguishing between legislative and interpretive rules." In publishing the proposed change, FDA said it is concerned about a trend in judicial opinions interpreting agency pronouncements as having the force of more formal rules, even though they were not intended as such. The agency said it could still "voluntarily follow such [notice-and-comment] procedures for any FDA pronouncement." FDA has said it does not intend to alter current agency practice regarding public comments, but rather intends to clarify FDA's legal responsibilities for the courts. In comments submitted Oct. 1, the American Bar Association's Section of Administrative Law and Regulation Practice also opposed the change. While a voluntary approach would allow "public participation in particular instances, which instances are left unspecified," the group stated. "The current regulation follows a more rigorous and reasonable policy."

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

UsernamePublicRestriction

Register

LL1132098

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