Policy

On May 6, 2005, in Policy
FDA Speeds Drug Clearances; Increasing Life Span; Regulation of Embryonic Screening and Reproductive Cloning; US Losing Its Edge
FDA Speeds Drug Clearances

money.cnn.com/2005/03/24/news/fortune500/fdadrugs/index.htm?section=money_latest

The US Food and Drug Administration approved 474 generic drugs in 2004, up nearly a third from 364 the previous year, and cut the approval process to a “record time” of 15.7 months from 17 months. It approved 29 non-generic “priority” drugs (drugs with the potential for significant advances over existing treatments) in 2004, compared to 14 in 2003, and the median time for approving priority drugs was 6 months in 2004 and 7.7 months in 2003.

Increasing Life Span

story.news.yahoo.com/news?tmpl=story&cid=534&ncid=534&e=2&u=/ap/20050301/ap_on_he_me/living_longer

Declines in death rates from most major causes — including heart disease and cancer — have extended Americans’ life expectancy to 77.6 years, and there is evidence of an increase in active life expectancy to boot. Still, the US lags in life expectancy behind Japan, Monaco, San Marino, Switzerland, Australia, Andorra, Iceland, Austria, Belgium, Canada, Finland, France, Germany, Greece, Israel, Italy, Luxembourg, Malta, Netherlands, New Zealand, Norway, Singapore, Spain and the United Kingdom.

Regulation of Embryonic Screening and Reproductive Cloning

www.newscientist.com/article.ns?id=dn7198

A British parliamentary committee has recommended that parents undergoing fertility treatment should be allowed to choose the sex of their baby for “family balancing.” New Scientist describes the report’s most radical recommendations as follows:

  • 1) That the emphasis on the screening and selection of embryos shift from the regulatory body, to the patient, within the law. This includes the option of sex selection for family balancing
  • 2) That while human reproductive cloning is banned in the UK, it is likely to take place somewhere in the world. If this were shown to be safe and effective “an indefinite absolute ban could not be considered rational”
  • 3) That hybrids and chimeras could be created legally for research if destroyed within the current 14-days allowed for human-embryo research
  • 4) That legislation should not require an assessment of the welfare of a future IVF child — beyond significant physical health problems — as this might be discriminatory
  • 5) That donors of eggs and sperm retain the option of remaining anonymous – clashing with a new law coming into effect after April 2005

While all this may be heartening or horrifying, depending upon one’s position on the scale from coldly rational to hotly religious, the key point to note is that MPs who approved the report said the laws and regulations, promulgated in 1990, governing human reproductive technologies were now “creaking under the combined weight of scientific and technological advance.” As we hope is obvious to readers of the Digest, that combined weight is on an exponential, accelerating roll, and the question is not so much what to do legislatively — rather, it is: Can today’s legislative processes keep pace at all?

US Losing Its Edge

www.edtv.gatech.edu/Default.aspx?tabid=797&mid=1405&ctl=NewsDetail&NewsID=44

A Georgia Tech researcher says that US leadership in science and technology is waning. She bases her assertion on several benchmarks:

  • The pursuit of doctoral degrees is increasing in Asia but declining in the US, and the number of Asian doctoral students in the US fell 19 percent between 1994 and 1998.
  • From 1995 through 2001, China, South Korea and Taiwan increased R&D spending by about 140 percent, while the United States increased its investments by only 34 percent. Sixty-eight percent of all domestic R&D money in the US now comes from the private sector, and three-fourths of it goes toward development instead of basic research.
  • Since 1988, the number of applications to the US Patent Office originating in Asia increased 789 percent, while domestic patent applications grew 116 percent.
  • The US share of science and engineering papers published worldwide fell from 38 percent in 1988 to 31 percent in 2001, in which year Western Europe achieved a 36 percent share. Over the same period, Asia’s share of published papers grew from 11 to 17 percent.

“It’s important to look at the long-range implications of these benchmarks,” she said.

 

Leave a Reply

Your email address will not be published. Required fields are marked *