P.1 

OAR Box 1872 

Prepped by Keeia Richards 

Document Number: 

90) 11-1-139 

Docket Number: 

A-90-19 

Printed 11/26/2008 8:52:01 AM Sheet 90 of 204 
. Jfe-*—~— 

Former FDA Man Indicted 

Tie former head of Food & Drug Ad-

•nmistralion's generic drug division has 

Len indicted in Baltimore. Md . on two 

counts of lying to government investigators about M i contact with pharmaceutical manufacturers 

The two Federal grand jury indictments, the latest round of charges in the 

two-year investigation of FDA and the 

generic drug industry, named Marvin 

Seife, who retired as director of the 

agency's generic drug division al the end 

of IW9 

Mr. Seife is the highest ranking FDA 

official to be indicted in the ongoing investigation and Ihe last to be charged in the 

corruption phase of the probe, according 

to t'S Attorney's office in Baltimore. If 

convicted ->f both counts, he (aces up to 10 

years in prison and J500.000 in fines Mr 

Seife, who held his position for 17 years, 

was responsible for reviewing applications from pharmaceutical manufacturers seeking approval lo market generic 

drugs 

The Indictments say that in 1989 Mr. 

Seife lied to an FDA investigator when he 

denied meeting wilh two generic drug 

makers in 1987 lo discuss agency business, and that he made a similar statement in testimony before a congressional 

committee 

Federal prosecutors say they expect to 

spend the next year seeking charges 

against pharmaceutical companies lhal 

may have cheated on safely tests required 

to gain FDA approval. Generic drugs are 

approved for sale if regulators conclude 

they arc equivalent to original namebrand products 

Energy Tax Could Fund 

Environment, Says Alcoa 

A national energy tax Is the only viable means of addressing the mounting 

environmental problems in the US, according to Paul H O'Neill, chairman and 

chief executive officer of Aluminu m 

Company of America 

Speaking al Ihe annual meeting of the Air 

& Waste Management Assu>:iation in Pillsburg. Mr 0'Nei|t challenged the Bush Administration to reduce ihe Federal deficit 

with the energy tax revenues in order to promote the investment thai will generate the 

necessary environmental dollars 

"As I think about the environment," Mr. 

O'Neill said, "nothing seems clearer lo me 

than ihe seemingly unseverable connection 

beiwe<-n the condition of the environment 

and ei.ergy utilization In fact, if we were 

limittd toonly one policy intervention to improve the environmental condition and future in the US. 1 would choose a policy aimed 

at energy productivity and conservation," he 

•aid. 

Asked how he (vll Congress would respond 

to such a tax US Rep Doug Walgren (D-Pa ). 

also speaking al the meeting, said that it 

would oniy StiCcecd '•'• '•'. were a truly bipartisan effort, or if the President took the leai 

Michael R. Deland. chairman of the president's Council on Environmental Quality, 

stressed that Ihe real answer to pollution 

control is to eliminate it at the source "V>e 

must shifl our focus to pollution prevention,'' 

he said, "rather than spending millions or 

billions lo clean up a nu-ss al ihe end of the 

pipe F 

According lo Mr. Deland. "Pollution prevention — not pollution control — will be the 

centerpiece of the Bush Administration's environmental agenda " 

A primary topic at ihe meeting, attended 

bv more than 5,000 environmental professionals, was the impending passage of the 

new Clean Air Act. 

Since a major concern centers on how to 

allord the implications of such legislation 

reaction to Mr. O'Neill's recommendation 

that energy lax revenues be applied to the 

Federal deficit were mixed. Many members 

countered lhat a more direct application of 

the funds to the energy programs might be 

more beneficial 

Rep Walgren stressed, however, thai unless thedeficit was brought under control, (he 

US would lose its ability to be competitive as 

an economy. 

When asked whether, In the face of this 

deficit, the US would support a Marshall-type 

plan for Eastern Europe, Mr. Walgren said 

that there would be support but it wasn't 

clear cc * the funds would be identified 

Mr O'Neill suggested that perhaps money 

isn't as important to solving the environmental problems of developing countries as is 

changing the expectations within them. 

House Gives Quick Okay 

To Waste Minimization Bill 

The House gave quick approval last 

week to legislation designed to encourage industry to minimize its output of 

waste. The bil l has the support of the 

chemical industry and other manufacturers because it takes a multimedia approach and encourages, rathe r than 

mandates, waste reduction 

Sponsored by Rep Howard Wolpe (DMich I. (he "Waste Reduction Act of 1990'" is 

likely to be ihe only waste management 

measure passed by Congress this vear The 

Resource Conservation £ Recovery Aci is up 

lor reauthorization, but efforts to pass the 

new (lean Air Act are expected to tie up the 

congressional environmental committees 

tor the remainder of the current session 

House passage of the waste reduction bill 

• » ! put pressure on the Senate lo act on an 

identical measure introduced by Sen. Frank 

Lauunberg (D-.N J.) lasl year The Senate has 

J>een reluctant to pass waste reduction legis-

«''«>ni thai is not part of a comprehensive 

J '"-'authorization package 

R K*» Vulpi"

bl11 'whir h ha s ,,Mf SUPP°« °' t h e 

D

«!>n Administration, attempts to shift the 

c u m nt emphasis on pollution treatment and 

Cleanup io po^mon prevention by providing 

industries with incentives lo reduce the 

ani '-' " nur -

turing. "This bill is aimed al where ihe problem begins.'' says Rep Wolpe "The best way 

lo deal with hazardous waste is not to produce it." 

Environmental Protection Agency administrator William K Reilly says the legislation 

is "a step in Ihe right direction. * but broader 

measures are needed He has told Congress 

the Administration considers pollution prevention its second highest environmental priority after renewing the Clean Air Act 

The bill would establish a national policy 

of placing a high priority on the reduction or 

elimination of hazardous wastes at tri r 

source and the recycling or treating of any 

hazardous waste that is generated The disposal of hazardous waste would be considered a last resort 

The legislation would direct EPA to set up 

an office to develop 3nd implement a strategy to reduce the production of hazardous 

wastes It waukl be responsible for coordinating the colloeiion of information abuul activities of companies under section 313 of the 

1986 superfund amendments. 

Manufacturers would be required to add 

data on efforts lo reduce waste chemicals to 

the information on toxic chemical releases 

they already must submit to EPA and certain 

slate officials 

DuPor 

To Sell 

E I . du Pont de Nemours 4. Co. says It 

has received Federal government approval to market the first Soviet drug 

licensed and clinicall y developed by an 

American pharmaceutical company 

The company says Food & Drug Administration has agreed to permit the use of "Elh -

mozine" (moncizine HCI) lor the treatment 

of abnormal and life-threatening ' 

rhythms known as ventricular arrhythrrti is 

These irregular heartbeats are caused by 

heart attack, coronary artery blockage and 

other disorders, and are directly linked to 

more lhan 300,000 deaths each year. 

Dr. John Mullane, director of drug development for Du Pont, says the drug was discos ered in ihe late 1960s in Moscow and has 

been available in the Soviet Union for about 

18 years Du Pom researchers first learned 

of the drug on a trip to the Soviet Union in 

1971. be say*. 

The company applied for FDA approval lo 

sell the drug in the US in September 1987. 

Manufactured and marketed by Du Ponl 

Pharmaceuticals, "Ethmonne" will be available in the US In September of this year 

Under ils agreement with Du Pont, the Soviet 

government will receive royalties of 4 percent. 

A key benefit of the drug is ils lack of side 

effects, limited mainly to nausea and dizztA-90-19 

11-1-139 

ness in 10 lo 15 percent of patients, ace 

to Dr Mullane He says compai 

medicines currently on the market can cause 

other arrhythmias.. 

Dr. Mullane says the average dally dose of 

Continued on Page <•* 

John L Uthoil, former chief operating oldert of 

Mallinckrodt Inc.. who hat bean ricci«.i 

dent and chief txacutiv* oifn.tr of Ctigtnc CorS

oraiion. Ha rtpiacts Dr Louis ramandui, who 

a» been named chairman ol ih« board. 

Patent Office Study Finds 

Dow Women Lead in Patents 

Dow Chemical Company leads corporate America in the number of companyowned patents granted to its women scientists and inventors, according to a 

study by the US Patent and Trademar k 

Office 

Spanning 1977 through 1988. the study says 

Dow. with 354 patents granted to women investors, has the most female patentees of any 

corporation receiving US paten's 

The study was prepared by the patent office as pari of ihe bicentennial celebration of 

the signing of the original Patent Act in 1790. 

Among the US-origin utility patents granted 

during the 12-year period, women inventors 

showed the greatest participation wilhin 

chemical technologies. 

Second lo Dow in patents issued to women 

was IBM Corporation, wilh 322. followed by 

General Electric with 252 Among other 

chemical companies listed in the study. Du 

Ponl was in eighth place wilh 136 and Union 

Carbide was ninth with 131 

Commenting on the a. i rank 

Popoff. president and CIF 

formance in this study not only l l 

have long provided opportunities for women 

in science, it also clearly demonstra; 

professional excellence »nd the leadership 

qualities of our women scientist 

standing contributions to science through 

their successes with Dow have been of 

benefit, not only lo their company, but to 

their Individual fields of scientific enWilh patents totalling 187, some of Ihe 

most outstanding Dow inventors In. 

Sally P Ginter, director of the chemitali and 

metals, solvents cal mag, and clecirnchemIcals technical service anJ development lab 

oratory in Dow's chemicals and performance 

products department. Midland Midi who 

Continued on Page 14 

Formaldehyde Demand Forecast 

To Hit 7.4 Billion Pounds in '94 

Formaldehyde demand in the US wil l 

expand 3 percent annually to 7.4 billion 

pounds in 1994, accord ing to a new study 

bvLFiegdonTaCroup Inc 1 jtjieCle^lajTd, 

Ohio-based market research firm . 

Average priccrwiii grow 3 7 percent annually, driven mainly by increases in methanol 

feedstock prices, which represeni~oycr J7D 

percent o[ formaldehyde m.-innfni-inrinp 

cous. As a result, formaldehyde value will 

reach J900 million 

Tb*rrn0S*l rtslns will continue to provide 

Ihe major formaldehyde market, but smaller 

market s such as polyacelal plastics , 

acetylenic chemicals and methyl diisocyanate *il | present growth opportunities, 

Freedonia siys 

Thermoset resins are used m3inly as adhertves and bonding apenls for the production 

of wood products such as plywood and particleboard Demand for thermoset res)ns. 

linked to mature, highly cyclical buildinjj and 

c<iraSUULtlutt-naa£lLei£J5_pxflji5;^ 

over 3 percent annuallxthrflu.gu.19jH lo 3 9 

6inWiTpo.unuT" 

IfTf-a^mg f'por'* n f n « tnm^ r IP plaw 

of fhiish^d_Mioodj)rodijci ..nlUJ 

wood 

grown 

theresins and sit 

moihyi marJteTT' 

The relatively small market for polyac 

etals will present opportunities bav 

metal replacement applu 

tive and other marked Carmaldchyde fonjandforpol'. 

U percent innMlttjilfllUtllffi .... n •_" 

i Milam EL ^ 

"SJxrnaldchyde v ni of 

acetylenicchemicalsjycr*., 

wil l espandjear i 

thrtiiuti-iAa»_iu 

Acetylenic chemical.' arc uatd in growing 

t l lor the producti. < ylene 

terephthalate plasn 

bumpers, while acetylene chem 

NCk i s letrahydroturan wil l . 

Continued on Page 20 

July 2.1930 Chr-.V.iCAL M.NP.XrTlHf. . 
P.3 

V-s. W 

Y V: 
P.4 

20 CHEMICAL MARKETING REPORTER July 2,1990 

Formaldehyde 

Continued from Page 5 

grotrth martlets in spandez fibers and elastomers. Formaldehyde usedjn theproduction of methyl dnsocyanaleslTi.U)lij..WiU 

prows.? percelit.annually through 1994 to 

290 million pounds. . 

•"Tn'DIs are used mainly for the production of 

rigid and resilient foamed polyurethanes. 

Demand for MDIs will be driven by continuing strong acceptance of resilient foamed 

products in new home construction and remodeling projects. 

Other markets for resilient foams, such as 

automotive and furniture cushioning, will 

also remain strong. A potential threat to 

growth in this area may result from restrictions in Ihe use of chlorofluorocarbon blowing agents in the production of foamed urethanes, Freedonia says. 

Pentaerythritol and hexamine, both facing 

mature markets, slow growth applications 

and pressures from competitive materials, 

will see below-averge growth. The majority 

of pentaerythritol is used in the production of 

alkyd resins for coatings, while hexamine's 

applications include curing agents for phenolic resins and nitrilotriacetic acid used in 

detergents. 

"Other uses" for formaldehyde have declined sharply in the last decade due lo regulations restricting many of formaldehyde's 

direct uses. With direct uses nearly phased 

out, demand in this segment, now confined 

largely lo resin production, will stabilize. 

SPECIALIZED PRODUCERS ACTIVE 

There are 14 producers of formaldehyde in 

the United Stales. Freedonja .estimates. four_ 

companies — Borde'nT Hoechsl Celanese. 

Georjfia-t'acilic and Dupont — conlrol~over 

iTTfee-fo"urtKs o7 U.S^formaldehyile_ptodLt, 

lion Nevertheless, relatively small specialize? producers such as Alcolac and Wright 

Chemicals maintain a presence in Ihe 

formaldehyde industxy^— ViO '•! (.life < 

Approximaiely(7()7percent of formaldehyde is consumed captively, maimy tor me 

production uf llieiiiiuselliiig iiains. Theremainderissold-on-ihc mcrchgiiHnafket? 

- wunthe exception oi_iormaiaem:'ae_resins', 

there afi; onTv a few producers nTparlwiritip' 

formaldehyde derivatives. There are only 

ffve producers of hexamine, four of methyl 

diisocyanales, and three of each of pentaerythritol and 1,4-butanediol. Vgrlical integration into upstream production. 0 f melhanoL 

feedstock" jinddownstream ..derivative prodncriDTTis an important sttalegvLin.Ths 

forjiaia^KyfleLUidiislry" 

Foreign trade (except indirectly in decreajin£expor|s of finished wooq.ntuiiluls) 

will continue to play a minor role in the 

fomiajde|iyd£jl!5^erWatiyeijn3^^ 

P

a

£jly " ample in meet future"needs. 

Ethyl Tries Again 

Continued from Page 7 

government. The now diversified Fortune 

SOO company had net sales and insurance 

revenues of $2.4 billion and a net profit of 

S231 million in 1989. 

In requesting prompt approval of its 

waiver application, Mr. Wilkins remarked, 

"Ethyl has met the statutory standard. Moreover, based on the results of Ethyl's lest program, total emissions in cars using the j.iditive — including emissions of benzene and 

formaldehyde — could be reduced by up to 

1.7 billion pounds by 1999." 

The test results showed that use of "HiTec" 

3000 reduced emissions of total regulated 

pollutants by 7.8 percent and nitrogen oxides 

by an average of 20 percent, according to 

Ethyl. 

The company also conducted tests to determine what impact, if any, use of the additive 

has on the materials used in automotive 

emission control systems. "The testing shows 

that HiTec' 3000 will not cause plugging of 

catalytic converters," says Mr. Wilkins. "In 

fact, Ethyl's testing shows that catalytic converter efficiencies were actually improved 

by the presence of the additive in the fuel." 

The Ethyl executive says these findings 

are supported by the experience in Canada, 

where the fuel additive has been used for the 

past decade. Automobiles in Canada tested 

using fuel containing "HiTec" 3000 at twice 

the concentration requested in the waiver 

have shown no signs of catalyst plugging after almost 100,000 miles of vehicle operalion, according lo Peiro-Canada, Inc. 

US auio makers have claimed in the past 

that the octane enhancer could clog catalytic 

converters, rendering them less effective for 

emission control. The auto industry did nol 

testify al Ihe hearing, but is expecied lo file 

comments wilh EPA next month. 

The waiver application filed with EPA is 

for approval at a concentration of 1/32 gram 

per gallon, or about Vi teaspoon for a 20-galion lank. 

In light of the ongoing efforts to reformulate gasoline lo reduce automobile emissions. Ihe company says it also conducted a 

series of tests lo confirm (he compatibility of 

"HiTec" 3000 with reformulated fuels. 

"The additive is compatible with a wide 

variety of fuel blends, and the emissions reductions made possible by use of the additive 

will complement the emissions reductions 

made possible by use of reformulated gasoline such as oxygenated fuels," sava Mr 

Wilkins. • 

He says the additive can be used to reduce 

Ihe aromatic content of reformulated gasoline without sacrificing octane, thereby further reducing emissions of both criteria pollutants and other pollutants such as benzene 

and formaldehyde. 

EPA has denied waiver applications for 

"HiTec" 3000 twice before, but Ethyl soys 

those efforts were based on limited programs. Mr. Wilkins says Ethyl went lo great 

lengths to design its new 48-car tesl program 

lo meet all EPA requirements. He also notes 

that automotive engine designs, particularly 

Ihe catalytic system, have improved significantly since ihe company first sought approval in 1978. 

If Ethyl wins EPA approval — no sure bet 

— one industry analyst says "HiTec" 3000 

could eventually generate sales for Ihe company of al least 1250 million per year based 

on 50 percent of the US market. 

F

"*Toxiic 

Seem Ti 

Banking officials are expressing support for legislation sponsored by Rep. 

John LaFalce (D-NY) to protect their 

institutions from getting stuck with superfund toxic waste sile cleanup costs 

when they foreclose on contaminated 

property. 

Under the 1980 superfund law, businesses 

and other property owners are responsible 

for removing toxic waste from their land. 

Two major court cases in the late 1980's left 

lenders responsible for the expensive 

cleanups if they assumed ownership of contaminated properties through foreclosure. 

"1 find it disturbing that courts, searching 

for deep pockets lo pay for superfund 

cleanups, have expanded superfund liability 

far beyond what Congress ever intended," 

said Rep. LaFalce, chairman of Ihe House 

Small Business Committee. 

Lee A. Schrocdcr, president of the small 

first national Bank in Dana, Ind., told the 

committee his institution supports several 

key businesses in Ihe rural town. He said he is 

concerned that the bank — along with those 

to whom it lends — could face ruin if slapped 

with superfund costs by foreclosing on a farm 

or gas station with toxic waste problems. 

Drug Units Merged 

By Novo Nordisk 

Novo Nordish AS has merged its Australian pharmaceutical operations. The 

merger, effective July 1,1990, means that 

Ihe two present operating subsidiaries, CSLNovo Pty. Ltd. and Nordisk Australia, will 

become Novo Nordisk Pharmaceuticals Pty. 

Ltd. (Australia). 

At the same time, the company says 

agreements have been signed with Commonwealth Serum Laboratory (CSL) that all manufacturing of insulin vials for Novo will be 

carried out by CSL, and with Wellcome who 

will handle the distribution of the entire 

product range and provide back-up detailing 

support to general practitioners and pharmacists.