We have previously noted that FDA has increasingly regulated through issuance of guidance documents – rather than through notice-and-comment rulemaking as required by the Administrative Procedure Act. The U.S. Senate Committee on Health, Education, Labor, and Pensions (the Senate HELP Committee) has also taken note of it, albeit without the flair and occasional snark our readers have come to expect from the FDA Law Blog!
Earlier this week, Senator Lamar Alexander (R-TN), the ranking member of the Senate HELP Committee, along with Senators Richard Burr (R-NC), Johnny Isakson (R-GA), and Orrin Hatch (R-UT), sent a letter to FDA Commissioner Margaret Hamburg “to express significant concern about [FDA’s] use of draft guidances to make substantive policy changes.” The letter notes that draft guidances are becoming default FDA policy, notwithstanding that they are issued for comment purposes only. Moreover, draft guidances are not revised, finalized, or withdrawn in a timely manner. Although the letter doesn’t mention it specifically, we note that some guidances (see, e.g., here) have been kicking around in draft form since the last century. The letter also notes that these guidances often do not take into account – or even worse, conflict with – the views of the scientific community. As we’ve noted in the past, this would be solved with notice-and-comment rulemaking.
The letter requests FDA to respond to the following information requests and questions:
Earlier this week, Senator Lamar Alexander (R-TN), the ranking member of the Senate HELP Committee, along with Senators Richard Burr (R-NC), Johnny Isakson (R-GA), and Orrin Hatch (R-UT), sent a letter to FDA Commissioner Margaret Hamburg “to express significant concern about [FDA’s] use of draft guidances to make substantive policy changes.” The letter notes that draft guidances are becoming default FDA policy, notwithstanding that they are issued for comment purposes only. Moreover, draft guidances are not revised, finalized, or withdrawn in a timely manner. Although the letter doesn’t mention it specifically, we note that some guidances (see, e.g., here) have been kicking around in draft form since the last century. The letter also notes that these guidances often do not take into account – or even worse, conflict with – the views of the scientific community. As we’ve noted in the past, this would be solved with notice-and-comment rulemaking.
The letter requests FDA to respond to the following information requests and questions:
1. A list of all Level I Draft Guidances, including the date issued, and the timeline with which youcontinue to read here
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