SENATOR GLENN, I WANT TO FIRST THANK YOU FOR PROVIDING ME THE OPPORTUNITY TO APPEAR BEFORE YOU AND THE COMMITTEE AND TO APPLAUD YOUR LEADERSHIP ON THIS VERY IMPORTANT ISSUE. I BELIEVE THAT THE REAUTHORIZATION OF THE PAPERWORK REDUCTION ACT PROVIDES A UNIQUE OPPORTUNITY TO REDUCE ONE OF THE SERIOUS ABUSES IN GOVERNMENT - THE OVERZEALOUS "REGULATORY REVIEW" ACTIVITIES OF OMB'S OFFICE OF INFORMATION AND REGULATORY AFFAIRS (OIRA). I ALSO WANT TO ACKNOWLEDGE THE IMPORTANT LEADERSHIP OF SENATOR BINGAMAN, BOTH FOR HIS AUTHORSHIP OF THE LEGISLATION NOW UNDER CONSIDERATION BY THIS COMMITTEE, AND FOR HIS RECOGNITION OF THE PROBLEM WHICH BRINGS ME HERE, TODAY, THE NEED FOR A STRONG "REGULATORY REVIEW" PROVISION IN THIS BILL. I BELIEVE THAT A LEGISLATIVE SOLUTION IS DESPERATELY NEEDED TO MAKE OMB MORE ACCOUNTABLE TO CONGRESS AND THE PUBLIC, AND I HAVE THUS INTRODUCED LEGISLATION IN THE HOUSE TO ACCOMPLISH THAT GOAL. I WILL SUBMIT A COPY OF MY BILL, H.R. 3314, FOR THE RECORD. THE HOUSE SUBCOMMITTEE ON HUMAN RESOURCES AND INTERGOVERNMENTAL RELATIONS, WHICH I HAVE THE PRIVILEGE TO CHAIR, HAS DOCUMENTED NUMEROUS INSTANCES WHERE OMB HAS INTERFERED WITH THE DECISIONMAKING PROCESS IN AREAS SUCH AS FOOD SAFETY, THE DRUG APPROVAL PROCESS, FOOD LABELING, AND WORKPLACE SAFETY. MY SUBCOMMITTEE IS NOT ALONE IN REVEALING OMB'S TAMPERING WITH THE REGULATORY PROCESS. A LIST OF CASES OF OMB MEDDLING WITH THE ACTIONS OF THE ENVIRONMENTAL PROTECTION AGENCY, THE OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, AND OTHER HEALTH AND SAFETY AGENCIES CAN BE OBTAINED FROM A VARIETY OF COMMITTEES AND SUBCOMMITTEES IN THE HOUSE AND THE SENATE. CONGRESS HAS PASSED HEALTH AND SAFETY LAWS, AND DELEGATED IMPLEMENTATION OF THOSE LAWS ONLY TO THE SPECIFIC AGENCIES WITH EXPERTISE IN THE RELEVANT SUBJECT MATTER. OMB HAS NO STATUTORY RIGHT TO ALTER THE DECISIONS OF THE AGENCIES EMPOWERED BY CONGRESS TO PROTECT THE PUBLIC'S HEALTH. IN MY VIEW, OMB'S so CALLED "REGULATORY REVIEW" ACTIVITIES OVER THE LAST EIGHT YEARS ARE ALMOST CERTAINLY ILLEGAL. PERHAPS THE MOST TROUBLING ASPECT OF OMB'S REVIEW OF REGULATIONS IS THE MANNER IN WHICH IT TAKES PLACE. BEHIND CLOSED DOORS, NAMELESS AND FACELESS OMB EMPLOYEES - USING THE POWERS GRANTED THEM NOT BY STATUTE, BUT BY EXECUTIVE ORDER FORCED EXPERT AGENCIES LIKE THE FOOD AND DRUG ADMINISTRATION TO ALTER REGULATIONS. OFTEN THESE ORDERS ARE ISSUED OVER THE PHONE, WITH NO DOCUMENTATION OF THE COMMUNICATION. LET ME BRIEFLY DESCRIBE A FEW CASES OF OMB INTERFERENCE THAT MY SUBCOMMITTEE HAS UNCOVERED: COLOR ADDITIVES THE FIRST CASE INVOLVES THE REGULATION OF COLOR ADDITIVES. IN 1982, FDA WAS PREPARED TO BAN SIX DIFFERENT COLOR ADDITIVES BECAUSE AGENCY SCIENTISTS DETERMINED THAT THE ADDITIVES CAUSED CANCER IN ANIMALS. UNDER A PROVISION OF THE FOOD, DRUG, AND COSMETIC ACT KNOWN AS THE DELANEY CLAUSE, CARCINOGENIC ADDITIVES MUST BE BANNED. AT THE URGING OF COLOR ADDITIVE MANUFACTURERS, OMB HELD NUMEROUS MEETINGS WITH OFFICIALS OF FDA AND THE DEPARTMENT OF HEALTH AND HUMAN SERVICES IN AN ATTEMPT TO PREVENT SOME OR ALL OF THE DYES FROM BEING BANNED. IN A REPORT THAT WAS UNANIMOUSLY APPROVED BY OUR FULL COMMITTEE, WE FOUND THAT: OMB'S EFFORTS TO INFLUENCE THE DEPARTMENT'S REGULATIONS (HHS' FAILURE TO ENFORCE_THE_FOOD, DRUG, AND COSMETIC ACT: THE CASE OF CANCER-CAUSING COLOR ADDITIVES, H. REP. 99-151, 99TH CONG., 1ST SESS., JUNE 3, 1985, P. 63.) REGULATION OF THE USE AND SALE OF EXPERIMENTAL DRUGS MY SECOND CASE CONCERNS THE ALTERATION OF A PROPOSED REGULATION DESIGNED TO EASE RESTRICTIONS ON THE USE AND SALE OF IN A 1987 HEARING, OUR SUBCOMMITTEE REVEALED THAT, AT OMB'S INSISTENCE, THE PROPOSED STANDARD OF APPROVAL FOR EXPERIMENTAL DRUGS TO TREAT "LIFE-THREATENING" ILLNESSES WAS DRASTICALLY ALTERED. (FDA PROPOSALS TO EASE RESTRICTIONS ON THE USE AND SALE OF EXPERIMENTAL DRUGS, 100TH CONG., 1ST SESS., APRIL 29, 1987.) PRIOR TO OMB'S INVOLVEMENT, FDA PROPOSED THAT DRUG SPONSORS BORE THE BURDEN OF DEMONSTRATING THAT A DRUG'S BENEFITS OUTWEIGHED ITS RISKS, AND THAT SUFFICIENT EVIDENCE OF SAFETY AND EFFICACY EXISTED. HOWEVER, OMB ORDERED THAT FDA'S PROPOSED STANDARD BE CHANGED. A NEW PROPOSAL REMOVED THE LANGUAGE REQUIRING SUFFICIENT EVIDENCE OF SAFETY AND EFFICACY. INSTEAD, OMB PLACED THE BURDEN ON FDA TO PROVE THAT THE RISKS POSED BY A DRUG WERE "UNREASONABLE" BEFORE THE AGENCY COULD REJECT AN APPLICATION. THIS CASE WAS ALL THE MORE TROUBLING BECAUSE THERE WAS NO DOCUMENTATION TO IDENTIFY WHICH OMB EMPLOYEES WERE RESPONSIBLE FOR REJECTING AN FDA PROPOSAL THAT SUFFICIENT EVIDENCE OF A DRUG'S SAFETY AND EFFICACY BE REQUIRED AS A CONDITION FOR APPROVING AN EXPERIMENTAL DRUG. OMB WAS SIMPLY ACTING IN THE VIDEO DISPLAY TERMINALS MY LAST EXAMPLE INVOLVES VIDEO DISPLAY TERMINALS. IN 1982, મ THE NATIONAL INSTITUTE OF OCCUPATIONAL SAFETY AND HEALTH (NIOSH) STARTED PLANNING A STUDY OF THE POSSIBLE HAZARDS OF VIDEO DISPLAY TERMINALS (VDTS) ON PREGNANT WOMEN, IN RESPONSE TO REPORTS OF BIRTH DEFECTS, MISCARRIAGES, STILLBIRTHS, AND OTHER REPRODUCTIVE IN 1985, THE STUDY DESIGN WAS COMPLETED, BUT OMB PROBLEMS. REFUSED TO APPROVE IT. OMB HAD NO SCIENTIFIC STAFF TO REVIEW THE PROPOSED STUDY, SO ITS CRITICISMS WERE BASED IN LARGE PART ON REVIEWS CONDUCTED BY TWO INDUSTRY CONSULTANTS. NIOSH REVISED THE STUDY AND TRIED TO ANSWER THE CONCERNS RAISED BY OMB. IN JUNE 1986, OMB APPROVED THE STUDY, UNDER THE CONDITION THAT NIOSH DELETE 69 QUESTIONS ABOUT STRESS AT WORK AND FERTILITY. THIS REPRESENTED APPROXIMATELY ONE-THIRD OF THE STUDY. SCIENTISTS AT NIOSH AND THE OFFICE OF TECHNOLOGY ASSESSMENT STATED THAT THE REVISIONS WOULD SERIOUSLY WEAKEN THE STUDY. NEVERTHELESS, OMB INSISTED THAT ITS REVISIONS BE INCORPORATED. AND NUMEROUS OTHER OBJECTIONS TO THE OMB REVISIONS. |