A renewed push for changes in drug regulation began at the highest level of the Department. HEW Secretary Joseph Califano felt that, for such changes to be effective, they had to be made through legislation rather than administrative policy. The initial bill, introduced in Congress on March 17, 1978, was titled the Drug Regulation Reform Act.

HEW Secretary Joseph A. Califano

It contained nine main provisions: to increase consumer protection, encourage drug innovation, increase consumer information, protect patient rights, improve FDA enforcement, promote competition and cost savings through generic drugs, increase FDA's public accountability, make additional drugs available, and encourage research and training. The effort during 1978 was unsuccessful, but the bill was reintroduced the following year. The Senate approved the bill in September 1979, but the House did not take action and the measure died.