Drug group assesses FDA approval process

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  • News of the Week

    preferred stock purchase rights plan, and increasing its employee stock ownership plan to own 16% of out-standing shares. Even in the shad-ow of a poor earnings outlook for 1989, the company inst i tuted a 3-for-2 stock split and increased its quarterly dividend in an attempt to "increase shareholder value." Earn-ings per share dropped from $5.04 in 1988 to $2.36 in 1989 on a post-split basis.

    Marshall attributes a 56% drop in net earnings (to $82.1 million) in 1989 to several factors. A signifi-cant one was decreases in prices and profit margins for polypropylene that began in the fourth quarter of 1988. The firm's major product line also suffered from increased industry capacity and shutdowns for main-tenance and expansions at a num-ber of the company's plants. How-ever, the company had a 20% return on equity and 1989 sales of $996 million, down 9% from 1988. With the announcement of the most recent proposed buyout, stock prices rose from $5V2 to $24% in one day.

    The $26-per-share offer has been called adequate by some analysts who continue to speculate about the possibility of competing offers. A special committee has been appoint-ed by Aristech's board to evaluate the Mitsubishi/Aristech manage-ment proposal. Huntsman Holdings is also looking at the proposal. When turned down in late November 1989, Huntsman had expressed a willing-ness to negotiate and possibly in-crease his offer.

    Ann Thayer

    Drug group assesses FDA approval process The Food & Drug Administration approved 23 new drugs last year, the most new molecular entities since 1985, according to the Phar-maceutical Manufacturers Associa-tion. PMA has a keen interest in this figure because its more than 100 member companies spent $7.3 billion last year researching and de-veloping these and other drugs.

    Of the 23 novel drugs, five are designed to treat cardiovascular dis-eases and three to treat cancers, the

    two leading causes of death in the U.S. Some also offer tangible treat-ment innovations. The cancer drug Zoladex (ICI Pharmaceuticals) treats advanced prostate cancer and may eliminate the surgical alternative removal of the testicles, explains John F. Beary III, PMA's senior vice president for science and technology. And Anafranil by Ciba-Geigy is "the first significant treatment for obses-sive-compulsive disorder, which af-fects 5 million Americans/' he notes.

    Beary also spotlights Losec by Merck, which FDA approved for in-flammation of the esophagus and related organs, as an example of the pharmaceutical industry 's march into basic research. Losec acts by interfering with acid production in the stomach by blocking the so-called proton pump.

    FDA took an average of 32.5 months to approve the 23 drugs, slightly longer than the previous year's average, PMA president Gerald J. Mossinghoff says. But FDA spokes-man William Grigg adds that six were approved in less than 15 months.

    The nation's largest environmental organizations have urged the U.S. government to strengthen its com-mitment, to the Great Lakes Water Quality Agreement, an internation-al agreement with Canada intend-ed to clean up pollution in the Great Lakes.

    Citing recent studies by the Gov-ernment Accounting Office and oth-er groups, the National Wildlife Fed-eration (NWF) and nine other envi-ronmental organizations asserted that the U.S. "is not adequately addressing toxic pollution of the Great Lakes ecosystem and . . . is not fulfilling its obligations under the Great Lakes Water Quality Agree-ment." That assertion was made in a Jan. 10 letter to Secretary of State James A. Baker III and Environmen-tal Protection Agency Administra-tor William K. Reilly. As of Jan. 18, NWF had not received a response.

    In the letter, the groups ask the federal government to take several steps to renew the nation's commit-ment to the Great Lakes agreement. These include supporting strong

    Of the 23 approved, 18 were first approved in other countries "that have approval systems comparable in quality to that of the U.S.," Mossinghoff says. Especially disturb-ing was that average FDA approval time for these 18 drugs was twice as long as in the country of first ap-proval. Mossinghoff says PMA fa-vors more resources for FDA to en-able it to review and approve new drugs more quickly.

    Grigg says FDA "has no data on foreign approval times for these par-ticular drugs. I do think different countries measure approval times differently." And he adds, "to be first in five of 23 approvals is quite an excellent record, a record per-haps no other country can match."

    The average development cost for a new drug now exceeds $125 mil-lion and is likely to increase, Mos-singhoff says. To stay competitive, the industry plans to invest $8.2 billion in research and development this year, double the amount it spent in 1985.

    Lois Ember

    Great Lakes air toxics control legis-lation as part of the reauthorization of the Clean Air Act, creating an advisory board to review existing environmental programs for compli-ance with the agreement, and help-ing with the creation of a database on the sources, loadings, and effects of pollutants in the Great Lakes.

    According to Melanie Griffin, a representative of the Sierra Club, which is one of the letters cosigners, "Congress has the opportunity in 1990 to pass a strong air toxics control bill that would dramatically reduce the toxics entering the Great Lakes."

    The Great Lakes agreement, signed 10 years ago, "is a model for inter-national cooperation to address shared environmental problems," the letter notes. The nation's fail-ure to implement the agreement, the letter continues, "not only jeop-ardizes the well being of the Great Lakes ecosystem, but it also under-mines the credibility of the U.S. gov-ernment in international environ-mental negotiations."

    Ron Dagani

    Stronger U.S. role in Great Lakes cleanup urged

    6 January 22, 1990 C&EN

    Drug group assesses FDA approval process