Fw: Congress Acts to Tighten Toxin Laws

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Tony Lambert "Tiger" ; MAM-NSIF@... ; lillian45usa2000@... ; pat2end@...

Sent: Sunday, October 14, 2001 1:10 AM

Subject: Congress Acts to Tighten Toxin Laws

Infection-Causing E. Coli Strain Is Found http://www.nytimes.com/2001/10/04/health/anatomy/04BLAD.html The New York Times Search October 12, 2001 With Anthrax Fears, Bayer Is to Lift Antibiotic Output Congress Acts to Tighten Toxin Laws By ROBERT PEAR ASHINGTON, Oct. 11 — Congress is rushing to tighten regulation of biological agents and toxins that could be used by terrorists. While generally supporting such legislation, scientists have expressed grave concern that some of the proposals could unintentionally interfere with biomedical research for legitimate purposes. F. DeBusk, a senior Commerce Department official who enforced export laws in the Clinton administration, said the government was continually falling behind industry in its efforts to control shipments of biological agents to foreign countries. "In view of the events of Sept. 11," Ms. DeBusk said, "the government should immediately review and update the list" of agents requiring export licenses. "The industry has invented new biological agents and concoctions, and the government is always several steps behind." Congress is also cracking down on the use and possession of biological agents in the United States. The principal antiterrorism bill in the Senate, introduced last week by the Democratic and Republican leaders, includes several provisions to control the possession of dangerous biological agents and toxins. Until 1996, it was relatively easy for foreign countries to obtain deadly biological agents from commercial suppliers in the United States. Congress and the Commerce Department tightened the rules in 1996, but they could not retrieve pathogens that had already been sold to Iraq, Iran, Syria, Russia and other countries. Congress Acts to Tighten Toxin Laws Under a 1996 law, laboratories must file reports with the government if they ship any of more than 30 biological agents listed by federal authorities. Under the legislation now moving quickly through Congress, laboratories would also have to inform the government if they merely possessed such agents. The agents include the bacteria that cause anthrax and bubonic plague, the toxin that causes botulism and the viruses that cause yellow fever and Ebola fever. Two House panels, the Judiciary Committee and the Committee on Energy and Commerce, have approved similar legislation to tighten control over microbes and toxins that could be used by terrorists. The Senate bill makes it a crime for anyone to possess a biological agent or toxin "in a quantity that, under the circumstances, is not reasonably justified by a prophylactic, protective, bona fide research or other peaceful purpose." The Commerce Committee bill makes it a crime for anyone to possess such agents with "reckless disregard for the public health and safety." All three bills would severely limit the ability of noncitizens to gain access to dangerous biological agents, even if they were doing research at a university or a laboratory in this country. People visiting the United States on business, tourist and student visas could not use or possess such agents unless they had permission from the Department of Health and Human Services. Congress is also rewriting the criminal laws so it would be easier for the government to convict anyone who misused biological agents. The government would no longer have to prove that the person intended to use microbes or toxins as a weapon. It would be enough if the government could show that the person was not engaged in "bona fide research" for a peaceful purpose. Some biological agents, like the botulinum toxin, have medical and cosmetic uses, but can also be used in weapons. In 1998, the Commerce Department imposed a civil penalty of $824,000 on Allergan, a California company that makes Botox, after finding that it had not obtained the necessary export licenses for more than 400 shipments of the product. In 1999, the department imposed a $708,000 penalty on another California company, CN Biosciences, after finding that it had exported biological toxins to various countries without licenses. The proposed new restrictions are in a Senate bill introduced last week by Senator Tom Daschle, Democrat of South Dakota, the majority leader. His proposal was based on a bill drafted by Senator ph R. Biden Jr., a Delaware Democrat who was focusing on biological weapons long before terrorists attacked the World Trade Center and the Pentagon. "The threat from anonymously delivered biological weapons and from emerging infectious diseases dwarfs the threat that we will be attacked" with ballistic missiles from the third world, said Mr. Biden, the chairman of the Foreign Relations Committee. Senator J. Leahy, Democrat of Vermont, said he worried that some provisions of the bill could have "a chilling effect on legitimate scientific inquiry that offsets any benefit in protecting against terrorism." M. Atlas, president-elect of the American Society for Microbiology, expressed a similar concern. http://www.nytimes.com/2001/10/12/national/12EXPO.html With Anthrax Fears, Bayer Is to Lift Antibiotic Output http://www.nytimes.com/2001/10/11/business/11BAYE.html The New York Times Search October 4, 2001, Thursday 2 Drug Makers to Pay $875 Million to Settle Fraud Case By MELODY PETERSEN Source: The New York Times Section: Business/Financial Desk 1049 words Abstract TAP Pharmaceutical Products, joint venture of Abbott Laboratories and Takeda Chemical Industries, agrees to pay $875 million to settle criminal and civil charges that it illegally manipulated Medicare and Medicaid programs; prosecutors contend that sales representatives for TAP gave doctors free samples of Lupron, drug used to treat prostate cancer and infertility, and then helped them get government reimbursements at hundreds of dollars for each dose; also indicted six current and former employees of TAP, including Alan MacKenzie, now president of Takeda Pharmaceuticals North America, charging them with conspiracy to pay kickpacks to doctors if they prescribed Lupron; Bristol-Myers Squibb and Schering-Plough have said they are being investigated by same prosecutors in Boston involved in TAP settlement; those investigations also involve questions about how companies marketed and priced drugs covered by Medicare; both companies say they have done nothing wrong (M) Lead Paragraph A joint venture of Abbott Laboratories and Takeda Chemical Industries agreed yesterday to pay $875 million to settle criminal and civil charges that it had illegally manipulated the Medicare and Medicaid programs. The settlement against the joint ve... http://search.nytimes.com/plweb-cgi/fastweb?state_id=1003039695 & view=site & docrank=9 & numhitsfound=2249 & query=%28%28Drugs%20ADJ%20%28Pharmaceuticals%29%29%3Ades%20NOT%20%28%28letter%29%3Atom%20OR%20%28caption%29%3Atom%20OR%20%28correction%29%3Atom%29%29 & query_rule=%28$query%29 & query1=thedbs%3DjustNYT%26thequery7%3DDrugs%20%28Pharmaceuticals%29%26thequery%3D%28Drugs%20ADJ%20%28Pharmaceuticals%29%29%3Ades%20NOT%20%28%28letter%29%3Atom%20OR%20%28caption%29%3Atom%20OR%20%28correction%29%3Atom%29 & query2=sorting%3DBYFIELD%3A-skey_pdate & query7=Drugs%20%28Pharmaceuticals%29 & query8=since%201996 & docid=98936 & docdb=2001arc & dbname=justNYT & numresults=10 & sorting=BYFIELD%3A-skey_pdate & operator=AND & TemplateName=abs_MPoff.tmpl & setCookie=1