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From the January 21st, 2001 issue of Smart Life News [v8n1]. Copyright (c) 2001. All rights reserved.


GHB Slated for FDA Approval in 2001

On October 2nd of last year, Orphan Medical, Inc. submitted its New Drug Application (NDA) to the FDA for “approval” of its Xyrem brand of GHB. Two weeks later, the FDA granted Orphan Medical’s NDA priority review status, which means that the FDA will decide on its approval within six months of its “acceptance.” On December 4th, the FDA accepted Orphan Medical’s NDA, which places a June 4th, 2001 deadline on GHB approval. According to Orphan Medical’s press release of December 4th, 2000 “the FDA has a goal of reviewing the NDA within a six-month time frame from the October 2, 2000 date of submission.” That means that the FDA could approve GHB by April 2nd of this year.

At the federal level, provisions for GHB’s approval have already been made. Xyrem-brand GHB will become a Schedule-III pharmaceutical once it is approved by the FDA. This means that an ordinary medical prescription will be sufficient to obtain it.

At the state level, there may be legal problems with Xyrem’s approval in states that have placed GHB in Schedule-I or Schedule-II. Some of these states have provisions in their controlled substances acts that automatically exclude any FDA-approved substance from the Schedule-I category, but I do not know whether or not this is universal. If you are in a Schedule-I state, you might want to verify this. In any case, Schedule-II states will still require that all GHB be prescribed in strict accordance with Schedule-II prescription practices. In California, this means a triplicate prescription.

At the present time, Orphan Medical intends to market Xyrem only as a liquid, and this may necessitate the use of antifungal preservatives. Whether or not compounding pharmacies will restock GHB when it gets approved is not known. However, GHB’s federal status as a Schedule-I substance is only temporary, lasting only 12 months (see subsection 2 below), with a possible (optional) six-month extension. The Federal Register notice for GHB was published on March 13th, 2000, so Schedule-I status for GHB should expire at midnight on March 12th, 2001.

The Temporary-Scheduling Provision of the Controlled Substances Act

(h) Temporary scheduling of substance in schedule-I to avoid imminent public safety hazard.

(h) (1) If the Attorney General finds that the scheduling of a substance in schedule I [21 USCS Section 812] on a temporary basis is necessary to avoid an imminent hazard to the public safety, he may, by order and without regard to the requirements of subsection (b) relating to the Secretary of Health and Human Services, schedule such substance in schedule I [21 USCS Section 812] if the substance is not listed in any other schedule in section 202 [21 USCS Section 812] or if no exemption or approval is in effect for the substance under section 505 of the Federal Food, Drug, and Cosmetic Act [21 USCS Section 355]. Such an order may not be issued before the expiration of thirty days from--

(h)(1)(A) the date of the publication by the Attorney General of a notice in the Federal Register of the intention to issue such order and the grounds upon which such order is to be issued, and

(h)(1)(B) the date the Attorney General has transmitted the notice required by paragraph (4).

(h)(2) The scheduling of a substance under this subsection shall expire at the end of one year from the date of the issuance of the order scheduling such substance, except that the Attorney General may, during the pendency of proceedings under subsection (a)(1) with respect to the substance, extend the temporary scheduling for up to six months.

(h)(3) When issuing an order under paragraph (1), the Attorney General shall be required to consider, with respect to the finding of an imminent hazard to the public safety, only those factors set forth in paragraphs (4), (5), and (6) of subsection (c), including actual abuse, diversion from legitimate channels, and clandestine importation, manufacture, or distribution.

(h)(4) The Attorney General shall transmit notice of an order proposed to be issued under paragraph (1) to the Secretary of Health and Human Services. In issuing an order under paragraph (1), the Attorney General shall take into consideration any comments submitted by the Secretary in response to a notice transmitted pursuant to this paragraph.

(h)(5) An order issued under paragraph (1) with respect to a substance shall be vacated upon the conclusion of a subsequent rulemaking proceeding initiated under subsection (a) with respect to such substance.

(h)(6) An order issued under paragraph (1) is not subject to judicial review.