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

DEA "EMERGENCY SCHEDULING" AUTHORITY IN REP. HUGHES' (D-NJ) BILL should be limited to drugs "which have no currently accepted medical use in treatment in the U.S.," the House Judiciary Subcmte. on Crime agreed April 26. The subcmte. unanimously passed the amendment during a markup of Hughes' Dangerous Drug Diversion Control Act (HR 4698). In a memo to subcmte. members, Hughes explained that with the revision the emergency scheduling authority "is intended to apply to the problem of 'designer drugs' which are the chemical analogs of existing controlled substances but have no medical use or value." As examples, the memo cited PCE and PHP, "which are clandestinely developed and manufactured analogs of the psychedelic drug PCP, or various substances sold as 'synthetic heroin.' As originally introduced, the bill would have permitted emergency scheduling of "any drug or other substance." Under the revised emergency scheduling provision notification in the Federal Register is required "at least 30 days prior to the Attorney General's scheduling action." Additionally, the bill would require "30-days notice to the secty. of HHS" in order to obtain comments from the dept. In addition to the emergency scheduling provision, the subcmte. made several other changes in the legislation, relating to OTCs, imports and exports, grants, placing controlled substances under seal when practitioners go out of business, and registration of practitioners. The revised bill was reported to the full House Judiciary Cmte. The revised bill restores the mandatory exemption from scheduling control for OTC drugs. Hughes' memo noted that the provision was "inadvertently" changed when the bill was first drafted. In another change the bill is "clarified to allow the importation of poppy straw and concentrate of poppy straw . . . under other than emergency circumstances," the memo says. During the mark-up Subcmte. Chairman Hughes indicated that a DuPont request that thebaine importation be permitted under this provision will be considered when the bill goes to the full cmte. The company formally asked for the change in April 25 letter to Hughes. The provision, DuPont Biomedical Products VP Hazen Richardson said, would more easily assure "a reliable supply of reasonably-priced thebaine." DuPont, which uses the substance in producing a number of products such as naloxone, naltrexone, and hydrocodone, currently "is limited" to purchasing thebaine from three domestic mfrs. whose price, $702 per kilogram, is more than double that which foreign producers have offered, he said.

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