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PARALLEL TRACK POLICY STATEMENT AND ACCOMPANYING CLINICAL HOLD REG MOVE TO OMB; FDA’s EXPEDITED APPROVAL REGULATION IS AWAITING SIGNOFF BY HHS SECRETARY

Executive Summary

The Public Health Service's parallel track policy statement and FDA's accompanying clinical hold reg amendments are nearing completion and could be published in May, barring any hold-ups at OMB. Both documents were sent to the Office of Management and Budget the week of April 23. In February, HHS predicted that the policy statement would be published in "early April" ("The Pink Sheet" Feb. 26, T&G-4). The clinical hold reg was slated for publication on April 30 in HHS' most recent regulatory agenda. The agenda, which appears in the April 23 Federal Register, explains that the amendments will "include additional grounds for placing an investigation on 'clinical hold' and for terminating an IND." Under the amendments, "FDA may require a sponsor to cease distributing an experimental drug in an open, noncurrently controlled investigation if any of several specified conditions exist." The conditions would presumably include a provision for halting expanded access if it is adversely affecting clinicals. FDA's expedited approval final reg was also slated for April 30 publication under the regulatory agenda. The document, however, has not yet cleared HHS and will still have to go through OMB. The reg, which codifies a compressed development plan for drugs to treat life-threatening and severely debilitating illnesses, was published as an interim final rule in October 1988 ("The Pink Sheet" Oct. 24, 1988, p. 3). FDA regs implementing the Orphan Drug Act have also not met FDA predictions for publication. Originally scheduled for release two years ago, the regs have reportedly been held up by OMB. FDA's last regulatory agenda in October estimated publication in December 1990, and the current agenda calls for release in October 1990. The proposed regs could be delayed even further if amendments to the Orphan Drug Act, introduced April 26 by Rep. Waxman (D-Calif.), are passed (see related story). Among other upcoming FDA documents, the agency expects to publish guidelines in July that instruct manufacturers on how to obtain clearance to export unapproved products. Final guidelines for state licensing of wholesale drug distributors under the Prescription Drug Marketing Act are scheduled for publication on July 31. A number of OTC monographs are also due out in the next year (see chart).
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