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Biotech / Medical : Biotech Valuation

CRSP 56.68

-2.4%

Dec 12 3:59 PM EST

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To: dalroi who wrote (326)	7/31/1999 12:32:00 AM
From: LLCF	of 52153

This looks positive for the industry: "Judge Curbs FDA Role On 'Off-Label' Therapy Drug Firms More Free to Push New Uses By Guy Gugliotta Washington Post Staff Writer Thursday, July 29, 1999; Page A01 <snip> "U.S. District Judge Royce C. Lamberth's memorandum yesterday ruled unconstitutional portions of last year's Food and Drug Administration Modernization Act that regulate the pharmaceutical industry's ability to distribute information on off-label drug applications. "The government, however benign its motivations, simply cannot justify a restriction of truthful, nonmisleading speech on the paternalistic assumption that such restriction is necessary to protect the listener from ignorantly or inadvertently misusing the information," Lamberth wrote <snip> "In a summary judgment one year ago, Lamberth found the FDA's guidelines unconstitutional. But after passage of the FDA Modernization Act, Lamberth agreed to review his ruling. "The redrawn guidelines contained in the law allowed pharmaceutical companies to disseminate peer-reviewed journal articles and texts to doctors as long as the firm met a list of conditions. "The law included a provision requiring the manufacturer to apply to the FDA for a new application for a drug before promoting it. Another provision required the manufacturer to submit promotional materials to the FDA for review before distribution. A third required the manufacturer to report semiannually on its promotional activities. "Lamberth rejected all of these requirements as indefensible violations of the Constitution: "The supplemental application requirement of the act amounts to a kind of constitutional blackmail," Lamberth wrote. "Comply with the statute or sacrifice your First Amendment rights." "The pharmaceutical companies' Trewhitt said that the industry interpreted Lamberth's finding narrowly -- confirming "the right of a company to give a reprint of a medical journal article to a doctor" as long as it is not "false or misleading" and as long as the company "discloses its interest in the drug" and notes that the application does not have FDA approval." See the whole article at: search.washingtonpost.com

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