Congress has dwed a b4U, H.R. 3605, that would extend th· term of patents lor df»g> st&ject to premarket appnrtrai by H>A %r ύρ fa five ye**s. II sound* simpli, but thife are % number of condition* on how the extension period is to be calculated. First, only on· h^f of * * mtitf$ phaae ma? be counts. Stamà,myt9^<^ymt^^ntià(Li»my»Û' able for any time in the approval process that the drug spends awaiting a decision by FDA. Third, drugs that already have been patented and tested butnof yet approved fcy FQA can get * maximum two*year extension. AMf&<m&* can the patent life left after approval *xoéé%$4 years. The bill also would e^iMir^A'è 3^rt^'4ni| approval procé­dants v^mi^^ before 19*2 16 Φ^^Μί^Μ^Ρ^ ίη other we**»' * generic ^f^^^^Ê^^^^^- ***** t o 9 i l o w

only that l**4^^ as a pioneer drug that; wm prt jÉttlïy determined to be safe and ef-

17,

GOVERNMENT CONCENTRATES

treble damages car profits when counterfeiting is don* intentionally and knowingly. And it would allow ex parte seizure» of counterfeit articles in cases in which the counterfeiter ignored lesser court orders ana destroyed of hid the counterfeit merchandise rather than cooperate with the Judicial system.

vtEBKtm âtiftiBrocK nnea lor tx^J) (Kpoeu EPA hae cited Diamond Shamrock with illegal di*· posai of polychlorinated biphenyls and has proposed a fine of about $2.4 million. The fine may be the largest ever imposed for PCB disposal violafàm» The complaint alleges that the company dumped 1228 tons of PCB-containing waete in 19?9 andlwQ at two sites not legally authorized to receive wastes containing PCBs. EPA began its investigation in May. 1983, after a routine check at 'Diamond Shamrock's Green Bayou plant near Houston. The company his 20 day» in which to respond to the citation, and am admit, deny, or explain the allegations. The compa­ny alio stay request a formal hearing on the charges, mm informal hearing to discuss settlement.

H*» Department crf Defease may have geod *eaeon ^ consider alternatives to the apace shuttle for launching it» satellites, according to a study by the Metional Research CoimciL Slow tumaround timet, th# need for stcurMy, **d expected pay load* that are beyond the capacity of tha ahuttie* make the case for havina other latmcKv»Wçlaa available. Three baing ow^demi, Hit Atlas Π, ÎÏ*À 34D7, and shuttle* derived SRB-7, are all ev*i*«è«)& in coat reliability, aod performance to the shttttlfc^ report finds. The panel chained by R a i » i i | - l i | l ^ , i a o£ Southern Method** V p | * « ^ r | é ^ ^ l ^ f h i ^ by DOO couW it* ability to launch psyioads tf some sort of "generic defect" were found that would ground the amail shuttle fte*. The aaaeewnent alio (tea* that the increased Qpo iMty and security of hawing other launch yehi-eke w o t ^ be ad vantageous in * crisis. The report eeHmates it wfll coat aiiout $Z billion to develop the aStetfWÉiiFw laitneh vehdyduMl»

fitt j i**i^^ which haa «own to involve net only consumer goods but W0am xs#lttial to human fcerith and safety, such a* rUHûSf»«T f « m and frcrike pfuta for automobiles. TfcW stasis a tot of a * w y i/wolved. It la estimated thfe$al«* lost becauseof foeeign^reduct counterfeit XmimtàmnA ieew **7 J million to &$A «dUkm b#*f**s#If^^ led***

pixmï*i)**m È#jn# ïkwrn* Wl·* taowingly and inleaiiiOfiaU* eâNt t iMra im^ wwi tuiiiiieiftHliia » ejlipi fji 1 ^ •[#( jR^yJM

8ep4wnbtr 17, %9ÊàOÊÊt4

Chesmod bot sent filed at Defense Thomas J. Welch has been appointed deputy assit* tant to the Secretary of Defense for chemical matters* He replaces Theodore S. Gold, who resigned tali summer. Welch comes from the Army's Chemical Research & Technology Center at Aberdeen, hUL, where he was an associate for technology. He is expected to take over the reins of his new position on Oct. 1. Once at the Pentagon, his first priorities likely will be attempts "to get our retaliatory postust straightened out, and work on arms control issues/' says spokesman Maj. Gen. David W. Einsel Jr., d*p*t» ty,assistant to the Secretary of Defense for atçajptf energy. Einsel adds that Welch will be working <?r* defensive matters, meaning securing Congressional support lor binary chemical weapons* "We still have got a long way to go to get our defensive posture up/' Einsel explains.

Coke mm mâaàm ailed hazardous EPA has listed pollutants from coke-producing oven· as hazardous air pollutants and will prepare regula­tions to reduce those emissions within the next year. The agency is basing its decision on a report on the carcinogenicity of the compounds in coke &v*£| emissions. These include benzene, /S-naphthylamiivt polycyclic organic matter, and trace metals such as cadmium, arsenic, beryllium, and chromium. The report estimates that 1.5 to 16 lung cancer death* per year are caused by exposure to these emissions. At* though most of the emissions are fugitive and difJK-cult to measure, the agency says between ISO and 1580 metric tons of coke ovm emissions for aie Jt*M!f*j%tr*oluble organic portion are produced animally. There is no indication of how much of a reduction in this figure will be sought.