FDA Eliminates Restrictions on New Biotechnology Drugs

Just because a drug is made from the new and evolving science of biotechnology doesn’t mean it needs stricter regulating than regular medicines, the Clinton Administration announced Thursday.

The Food and Drug Administration is eliminating restrictions on biotechnology that could save the industry hundreds of millions of dollars and speed the development of biotech drugs. The moves are part of an administration package of regulatory reforms.

Biotechnology uses living organisms to create everything from slow-ripening tomatoes to complex gene therapy. When the field took off in the early 1980s, the FDA regulated biotech drugs more strictly than traditional ones because doctors knew so little about how the human body would react to such medicines.