The Regulation Atmosphere

The pharmaceutical industry is cautiously optimistic that the new Bush administration and Congress will continue efforts to streamline the drug discovery and approval process. But the federal regulatory and licensing landscape will also be shaped this year by patent reform and gene therapy issues. In addition, two major pieces of legislation--one affecting drug approval times and the other market exclusivity--will either be phased out or reauthorized in the coming 18 months. "We really c

| 4 min read

Register for free to listen to this article
Listen with Speechify
0:00
4:00
Share

The pharmaceutical industry is cautiously optimistic that the new Bush administration and Congress will continue efforts to streamline the drug discovery and approval process. But the federal regulatory and licensing landscape will also be shaped this year by patent reform and gene therapy issues. In addition, two major pieces of legislation--one affecting drug approval times and the other market exclusivity--will either be phased out or reauthorized in the coming 18 months.

"We really can't say much about where the [Food and Drug Administration] may be headed under the Bush administration" until a new commissioner is named, says Jeff Trewhitt, spokesperson for the Pharmaceutical Research and Manufacturers of America (PhRMA). But he believes the American public is "pretty comfortable" with current drug standards and procedures, and notes that the drug industry is not seeking major changes to the process. The industry is heartened by the Republican National Committee's party platform, which ...

Interested in reading more?

Become a Member of

The Scientist Logo
Receive full access to digital editions of The Scientist, as well as TS Digest, feature stories, more than 35 years of archives, and much more!
Already a member? Login Here

Meet the Author

  • Ted Agres

    This person does not yet have a bio.

Published In

Share
Image of small blue creatures called Nergals. Some have hearts above their heads, which signify friendship. There is one Nergal who is sneezing and losing health, which is denoted by minus one signs floating around it.
June 2025, Issue 1

Nergal Networks: Where Friendship Meets Infection

A citizen science game explores how social choices and networks can influence how an illness moves through a population.

View this Issue
An illustration of green lentiviral particles.

Maximizing Lentivirus Recovery

cytiva logo
Unraveling Complex Biology with Advanced Multiomics Technology

Unraveling Complex Biology with Five-Dimensional Multiomics

Element Bioscience Logo
Resurrecting Plant Defense Mechanisms to Avoid Crop Pathogens

Resurrecting Plant Defense Mechanisms to Avoid Crop Pathogens

Twist Bio 
The Scientist Placeholder Image

Seeing and Sorting with Confidence

BD

Products

The Scientist Placeholder Image

Agilent Unveils the Next Generation in LC-Mass Detection: The InfinityLab Pro iQ Series

The Scientist Placeholder Image

Agilent Announces the Enhanced 8850 Gas Chromatograph

parse-biosciences-logo

Pioneering Cancer Plasticity Atlas will help Predict Response to Cancer Therapies