A commission advising Congress on the federal drug approval process yesterday concluded that a number of administrative changes could get new drugs onto the market more quickly but that no overhaul of existing law is required.

The Commission on the Federal Drug Approval Process outlined 40 recommendations, including:

* A significantly expanded role for outside advisers in the development and approval process.

* Less government monitoring.

* Reductions in the amount of information required for submission to the government.

The 26-member panel, composed of industry, academic, medical, legal and public representatives, was set up last summer at the request of Reps. James H. Scheuer (D-N.Y.) and Albert Gore Jr. (D-Tenn.), two subcommittee chairmen from the House Science and Technology Committee.

"There are a variety of ways to expedite the approval of new drugs without compromising public safety or confidence," Scheuer said. But while the congressmen and members of the panel appearing at a news conference described the report as a consensus document, at least one consumer member submitted a separate and generally dissenting statement.

William Schultz, of the Ralph Nader-founded Public Citizen Litigation Group, warned that some of the recommendations could result in subjecting people participating in drug experiments to "new and unjustified risks."

Schultz, who charged afterward that the panel seemed stacked in favor of industry, specifically complained about recommendations increasing the role of outside experts during the drug testing period, as well as a suggestion to cut back the submission of raw data from individual case reports and allow drug companies to submit summaries instead.

Gore sought to minimize the debate, acknowledging that some of the recommendations were bound to be controversial and emphasizing that the report must now be open to the "full light of public debate."

One issue on which the entire commission agreed was that improving the drug approval system did not require changes in the existing legislative requirements that each drug must meet standards for safety and effectiveness.

But management changes recommended included simplification of laboratory testing requirements, appointment of an ombudsman to ensure timely resolution of disputes, establishment of a computer-based system to track the progress of new drug applications, less restrictive interpretation of conflict-of-interest statutes, less cumbersome procedures for experiments with so-called emergency drugs and establishment of an experimental mechanism to allow approval of human testing by "qualified non-government review boards" instead of the Food and Drug Administration.

Scheuer applauded the cooperative efforts of the Reagan administration even before the ink was dry on the commission's report. On Wednesday, the Department of Health and Human Services, FDA's parent, announced a number of management changes under way to "streamline" the drug approval process. Unit Cites Ways to Speed Drug Approval Process By Cristine Russell Washington Post Staff Writer

A commission advising Congress on the federal drug approval process yesterday concluded that a number of administrative changes could get new drugs onto the market more quickly but that no overhaul of existing law is required.

The Commission on the Federal Drug Approval Process outlined 40 recommendations, including:

A significantly expanded role for outside advisers in the development and approval process.

Less government monitoring.

Reductions in the amount of information required for submission to the government.

The 26-member panel, composed of industry, academic, medical, legal and public representatives, was set up last summer at the request of Reps. James H. Scheuer (D-N.Y.) and Albert Gore Jr. (D-Tenn.), two subcommittee chairmen from the House Science and Technology Committee.

"There are a variety of ways to expedite the approval of new drugs without compromising public safety or confidence," Scheuer said. But while the congressmen and members of the panel appearing at a news conference described the report as a consensus document, at least one consumer member submitted a separate and generally dissenting statement.

William Schultz, of the Ralph Nader-founded Public Citizen Litigation Group, warned that some of the recommendations could result in subjecting people participating in drug experiments to "new and unjustified risks."

Schultz, who charged afterward that the panel seemed stacked in favor of industry, specifically complained about recommendations increasing the role of outside experts during the drug testing period, as well as a suggestion to cut back the submission of raw data from individual case reports and allow drug companies to submit summaries instead.

Gore sought to minimize the debate, acknowledging that some of the recommendations were bound to be controversial and emphasizing that the report must now be open to the "full light of public debate."

One issue on which the entire commission agreed was that improving the drug approval system did not require changes in the existing legislative requirements that each drug must meet standards for safety and effectiveness.

But management changes recommended included simplification of laboratory testing requirements, appointment of an ombudsman to ensure timely resolution of disputes, establishment of a computer-based system to track the progress of new drug applications, less restrictive interpretation of conflict-of-interest statutes, less cumbersome procedures for experiments with so-called emergency drugs and establishment of an experimental mechanism to allow approval of human testing by "qualified non-government review boards" instead of the Food and Drug Administration.

Scheuer applauded the cooperative efforts of the Reagan administration even before the ink was dry on the commission's report. On Wednesday, the Department of Health and Human Services, FDA's parent, announced a number of management changes under way to "streamline" the drug approval process.