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

OMB's ROLE IN OSHA DELETION OF WORKER EXPOSURE LIMIT CHALLENGED by five democratic congressmen June 28 in a amici curiae (friends of the court) brief filed in the D.C. Circuit Court. The brief supports a Health Research Group petition, which requests that the court reverse a decision by the Occupational Safety & Health Administration (OSHA) to omit a short-term exposure limit from a final standard for worker exposure to ethylene oxide. Noting that the Labor Dept. last year proposed an ethylene oxide exposure standard that included a short-term exposure limit, the congressmen's brief states that OSHA dropped the short-term limit at the recommendation of the Office of Management & Budget (OMB). The brief contends that OMB required OSHA "to apply statutorily impermissible cost/benefit criteria, rather than the health and safety criteria" for setting regulatory standards under the law. The brief was submitted by House Energy & Commerce Cmte. Chairman Dingell (D-Mich.), Judiciary Cmte. Chairman Rodino (D-NJ), Govt. Operations Cmte. Chairman Brooks (D-Texas), Education & Labor Cmte. Chairman Hawkins (D-Calif.), and Post Office & Civil Service Cmte. Chairman Ford (D-Mich.). The document was prepared by the D.C. law firm Arnold & Porter. OMB's influence on the OSHA ethylene oxide standard is a specific example of the office's "pervasive interference in the rulemaking process," the brief maintains. Other examples of OMB "interference" in federal govt. rulemaking cited by the congressmen include the application of OMB cost/benefit standards to the Infant Formula Act of 1980, which "has caused the delay in the promulgation of FDA regulations . . . thereby allowing a substantial amount of defective infant formula to enter the market." In addition, Dingell's Oversight Subcmte. has questioned the propriety of administration efforts to block FDA regulation of sulfites, and Brooks' cmte.'s Intergovernmental Relations Subcmte. has challenged OMB's role in blocking the agency's color-regulating decisions.

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