FDA's AUTHORITY AS SEMI-INDEPENDENT REGULATORY AGENCY IS BEING RESTRICTED BY HHS TOPSIDE AND OMB: POLITICAL LANDSCAPE IN ADMINISTRATION CHANGING

The Office of Management and Budget's recent request for a rescission of the children's aspirin packaging restrictions indicates the extent of oversight and policy initiatives in the drug regulatory area from administration levels above FDA, Proprietary Assn. 1984 Chairman Charles Pergola told the group's annual meeting April 22. "Just a few weeks ago," Pergola noted, the Office of Management and Budget (OMB) "was telling FDA in no uncertain terms it didn't like the 36-pill-per-package limit now in place for children's aspirin. That's a long way from budget management." OMB has also been very active in the final clearance of OTC Monographs, P-A President Jim Cope reminded the assn. Cope pointed out that the recent wave of monograph activity -- marked by nine tentative final monographs published in January -- was due primarily to the breaking of the "logjam" at OMB. "The FDA is no longer a semi-independent agency with lines of communication we all know and understand," Pergola declared. "New lines are necessary to political leaders beyond the scientists and the career regulators at FDA." As another example of the policy directives from above, Pergola told P-A: "Keep in mind the HHS secretary announced the original decision on Reye's Syndrome labeling." Similarly, FDA Com. Young's Action Plan initiatives for procedural reforms at FDA are pending publication until HHS Secty. Heckler can make the formal announcement. OMB And HHS Oversight May Create Delay And Political Vulnerability In Health Policy The attention to health issues at levels above FDA is not new in Washington, but P-A's reference to the changing political landscape in the health policy field highlights a new degree of topside involvement. Pergola's comments also intimate a growing concern among the regulated industries that too much control from above may create awkward and inconsistent regulatory decisions. During the last five years, the regulated industries have perceived new opportunities for seeking review of FDA policies from higher levels within HHS or from OMB and the White House. For example, the Cosmetic, Toiletry and Fragrance Assn. went to OMB in the Spring of 1983 to seek a review of a preliminary decision to ban D&C No. 19. An OMB official passed that request back through HHS to FDA. The Pharmaceutical Mfrs. Assn. recently used the same approach through OMB to seek a review of the NDA Rewrite provisions for new drug applications. P-A's choice of the aspirin package limits and the monograph publication procedures as examples of the new layers of oversight indicates the assn.'s concern that a pattern of excessive review from above may not be helpful to the industry in the long-run. By slowing the OTC Review process at this late stage, OMB review of the monographs probably does little but delay the end of the first phase of the OTC Review. That delay ties up FDA initiatives to get on with the next subjects such as Rx-to-OTC switch procedures. The aspirin packaging change could raise the long silent issue of accidental ingestion by children. The extent of delays due to double-checking of regulatory policy within the administration is also indicated by the long period of time it took for the labeling exclusive terms policy to be issued. In May 1984, P-A said that the policy was at OMB for final review. OMB, however, massaged the policy for another 11 Months. In one letter from OMB Administrator for Information & Regulatory Affairs Douglas Ginsburg to FDA Com. Young in early October, the OMB official asked for a meeting to go over the policy. The OMB staffer wrote to Young: "White I know you agree that the proposal that the staff made before you arrived is probably unconstitutional, I have some thoughts about how we can nonetheless get maximum value for consumers and mfrs. alike, out of the considerable effort that has already gone into developing specific wording on indications for use established under the OTC monographs."