Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : PFE (Pfizer) How high will it go? -- Ignore unavailable to you. Want to Upgrade?

To: BigKNY3 who wrote (6518)	12/19/1998 11:28:00 PM
From: BigKNY3	Respond to of 9523

changes at fda but not in priorities, says henney December 18, 1998 Marketletter via NewsEdge Corporation : Jane Henney's priority as US Food and Drug Administration Commissioner is the full and effective implementation of the FDA Modernization Act, she told the annual meeting of the US Food and Drug Law Institute last week, just one day after taking the oath of office. While noting that it was too early for her to make policy pronouncements or predictions, Dr Henney told the meeting that it was good to be "recalled. " The FDA is much different to when she was last there in 1994, and some of its processes have changes as a result of FDAMA and RE-GO (reinventing government), she noted, but this has not changed agency priorities. Need For FDA Leadership To "Stay Focused" Managerial experience in public health organizations is her forte, but being FDA Commissioner is about leadership. It will be for her and for the top FDA leadership to stay focused on what is important, she noted, especially implementing FDAMA, in both its spirit and letter. The agency has made remarkable progress in doing that, without additional resources and while doing its regular work, she noted, and agreed with the FDAMA directive to be in touch with agency stakeholders, as listening to this input will maximize agency effectiveness. This dialogue needs to be ongoing, she added. While the agency has been directed under FDAMA to identify where it is not meeting its statutory obligations, and how to correct the situation, she said that she is committed to the congruence between the law, policy and outcomes but will not hesitate to point out where this cannot be done. Dr Henney also stressed her commitment to strengthening the agency's science base, which must guide critical policy decisions and reviews. The science base is also important for field staff, she said; the agency must pay attention to recruiting and retaining top personnel, and leveraging scientific expertise at other government institutions and in academia. The FDA must have the scientific knowledge to keep up with the complex products being developed as a result of huge investments in basic research within other branches of government and in industry, she said. Other priorities include focus on administration initiatives on food safety, blood supply and tobacco regulation. With the ongoing budget constraints imposed on the FDA, she said, it is important to keep priorities in mind. Quoting from a speech she made to the FDLI as an FDA representative seven years ago, she said the FDA still faces challenges, still lives in difficult times and still needs to find innovative solutions to problems. It needs to re-examine itself constantly and to redefine its efforts to meet its goals, she said, while never missing a chance to evolve to meeting those goals. Any New Waxman-Hatch Law "Will Be Fair" It is unclear if Congress will develop a new version of the 1984 Waxman-Hatch legislation, Orrin Hatch told the meeting, but he pledged that any action will be fair. Sen Hatch also pledged to work with Judiciary Committee chairman James Jeffords, during upcoming hearings on the issue, to assure fairness. Pointing to the huge monetary investment by both government and industry, he said there is a need for incentives and protections for that research as well as an assurance that the medications developed as a result of this research will be affordable. He also expressed confidence that FDA Commissioner Henney will treat the dietary supplement industry fairly, and hoped for a new attitude at the agency regarding these products. Noting that consumer use of dietary supplements has skyrocketed, he said that consumers do not understand the legal differences between pharmaceuticals and dietary supplements, but assume that supplements are safe and effective and that they come under the same scrutiny as pharmaceuticals. While pointing out that most dietary supplements are safe and effective, he encouraged consumers and industry to work with the FDA to solve any problems. He was also hopeful that Dr Henney will not push innovative new products with compelling science, such as Benecol, into the drug box or tie these products up in other ways for years so that consumers cannot benefit from them. Agency Is "Seriously Underfunded," Says Hatch Among his priorities for the agency are the securing of adequate resources to accomplish all that it must; the FDA is seriously underfunded, he said, and volunteered to be an advocate for needed resources. It also needs adequate facilities and space, he added. Recruitment and retention of a highly-skilled workforce is also important, he commented, and with the departure of several top employees from the FDA, it will be the task of Commissioner Henney to put in place a top leadership team. He particularly praised the work of outgoing head of the Office of Regulatory Affairs Ron Chesmore, FDA Deputy Commissioner Michael Friedman and outgoing Deputy Commissioner Bill Schultz. The FDA is one of the most important, if not the most important, agency within the government, said Sen Hatch, and all must be assured that scientific facts and the law are driving decisions at the agency. Call the shots the way you see them, he advised Dr Henney, and stakeholders should support FDA decisions even if they do not like them. Sen Hatch pledged to be both the agency's best friend and severest critic, commenting that while there is much good about the FDA, there is also much that can be improved.

To: BigKNY3 who wrote (6518)	12/19/1998 11:31:00 PM
From: BigKNY3	Read Replies (1) \| Respond to of 9523

Recalling the Year That Was By David Foster Associated Press Writer Thursday, December 17, 1998; 12:08 p.m. EST There were other stories this year in America, you know. Think of Texas floods and Florida fires. Think of Wall Street's wild ride and John Glenn's even wilder one. Think of Viagra! Think of anything but presidential sex, lies and videotape. This 1998 retrospective certainly won't dwell on that tawdry matter. We in the media know you're sick of it all, from the cigar to Starr, and have been for months. So you said in survey after survey. So you declared on Election Day, according to the pundits. Yet few among us, writers and readers alike, could help but keep watching as the sorry details emerged, holding our hands over our eyes while peeking out between our fingers. To some extent, that's how America dealt with all of 1998, a year in which we grew more adept at filtering reality to our liking. With high-tech help from V-chips, Internet cookies and 100 cable channels, it was easier than ever create our own private takes on the world. Our president led the way, inventing a planet where telling the truth differed from being ''legally accurate,'' but we're done with that subject -- remember? -- so let's move on to another example: the economy. All year, Asia's slump threatened to drag the world into recession. Yet America diligently ignored the bad news abroad to forge an unlikely prosperity at home. Gas was cheap. Mortgage rates were low. Even the federal government made money, posting its first budget surplus in 29 years. The stock market, despite hair-raising fluctuations, seemed as Teflon-coated as Clinton's political career. (Oops, sorry. No more scandal references, and that's a promise.) Since screening out the big, bad world seemed to work wonders on Wall Street, who could blame us for trying selective myopia elsewhere? Powerful new drugs yielded another year of declining AIDS deaths in America, a cause for celebration if we ignored the 95 percent of AIDS sufferers worldwide who couldn't afford those drugs. Gulf Coast residents could be thankful that Hurricane Georges was destructive but not particularly deadly -- as long as they didn't look south, where Mitch killed more than 10,000 people in Latin America. Many stories of 1998 were neither purely good nor evil, merely full of dueling ambiguities that dared us to find a personal perspective that made sense. U.S. warships pointed their cruise missiles at Iraq but backed off when Saddam promised to cooperate with arms inspectors, not that anyone believed him. Trustbusting prosecutors stormed Bill Gates' software fortress, cheered on by Microsoft competitors with market-dominating dreams of their own. Dr. Jack Kevorkian continued his grim reaping and faced first-degree murder charges for what he called a mercy killing. Republican leaders in Congress, expecting Democrats to be dragged down by you-know-who's problems with you-know-what, strolled confidently into the November election. They staggered away in shock, their majority thinned. Newt Gingrich quit his job as House speaker, even as former pro wrestler Jesse Ventura started a new career as Minnesota's governor. While pundits puzzled over those turns, other news needed no expert analysis. As anyone could see, it was just plain bad. The bizarre turned routine in a bloody string of school shootings in Jonesboro, Ark.; Edinboro, Pa., and Springfield, Ore. Hundreds of law officers combed the woods of North Carolina for bombing suspect Eric Rudolph, and another manhunt in Utah's canyonlands sought a pair of cop-killing survivalists. Both searches came up empty. Hate wore many faces: A black man was dragged to death in Texas. A gay college student was beaten and left to die in Wyoming. An abortion doctor was shot to death through his kitchen window in New York. The Red Cross spent more in 1998 than in any previous year, tending to a nation that seemed to have enrolled in the Natural Disaster of the Month Club. While hurricanes and tropical storms were the most destructive, other weird weather took its toll. A tornado wiped Spencer, S.D., off the map. A half-million charred acres in Florida and a deadly heat wave in Texas left Gulf Coasters praying for rain, which finally flooded in with a vengeance. And Frank Sinatra died. With so much bad news, it was tempting to follow the lead of Hillary Clinton, who swore off reading newspapers. (Please note, by the way, that since there's no mention here of WHY she stopped reading, this writer has technically not broken his promise, depending, of course, on how you define ''promise.'') Now, where were we? Oh yes, bad news. There was plenty of it, to be sure, but completely shutting out the world to avoid it also would have meant missing some of the good tidings of 1998: Impotent men rejoiced as Viagra lifted their spirits. IRS officials promised to be nicer, not that anyone believed them. Keiko, the killer-whale star of ''Free Willy,'' made his own real-life escape from an Oregon aquarium to a sea pen near Iceland. States won a $206 billion settlement from tobacco companies for the cost of treating sick smokers. A duel of sluggers returned the magic to baseball. Mark McGwire won the good-natured race with 70 home runs to Sammy Sosa's 66 for the season, and both basked in the glory of shattering the 61-homer record set 37 years ago by Roger Maris. John Glenn took America on another nostalgic ride, blasting into orbit at age 77. By turning the space shuttle Discovery into an Elderhostel, Glenn helped make space exploration exciting once more. He gave America a reason to look ahead brightly, past the worrisome Y2K hump, toward a millennium when nations may work in peace aboard a space station, an era when the world may finally have forgotten a certain White House intern (not that we're talking about her now, mind you). ''Zero-g and I feel fine,'' Glenn said, again, floating about with a grin as he demonstrated one of the most satisfying ways to look at 1998. Through his distant lens, the world still was a place of hope, a blue jewel in the cosmos waiting for us to throw away the filters and see its beauty, this time with our eyes wide open. ----