Recently, the Combination Products Coalition (“CPC”) wrote a letter to Leslie Kux, FDA’s Assistant Commissioner for Policy, to reiterate a June 2014 comment regarding concerns with FDA’s guidance development process. The CPC is a group of leading companies in the drug, device and biologics industries. The Coalition states it works to “improve the regulatory environment for combination products by developing and advocating policy positions on regulatory issues affecting combination products.”
CPC’s letter stresses that many of the problems with FDA guidance development have been around for years. The Coalition notes that FDA guidance development “is crucial to spurring medical innovations that help patients,” and should have an ultimate goal to provide manufacturers with clarity about FDA expectations, which facilitates development of medically important products, and helps ensure compliance with FDA requirements.
However, CPC alleges the current guidance development process needs improvement and proceeds to list several specific issues. CPC cites the time it takes to develop important guidances as a concern. The Coalition points out that manufacturers have long awaited guidance on combination product Good Manufacturing Practices (“GMP”) that would clarify the meaning of ambiguous regulations. Additionally, manufactures are still waiting for FDA’s guidance on the co-development of drugs and companion diagnostics.
Another problem with FDA’s process is the inability to update guidance in a timely fashion. CPC points out that it has asked FDA on several occasions to update its 1991 Intercenter Agreements — documents intended to explain the assignment of center jurisdiction over combination products. For several years, FDA itself has acknowledged that the Intercenter Agreements do not accurately reflect the current state of jurisdictional assignments, but these documents have yet to be updated.
CPC’s letter reflects some concerns raised by other stakeholders and previously reported on Policy and Medicine. Members of the Senate Committee on Health, Education, Labor, and Pensions (HELP) sent a letter to FDA Commissioner Hamburg, expressing concern that the agency was using draft guidances to make substantive policy changes. Increasingly, draft guidances are becoming a “default FDA policy and position,” which concerned several members of the HELP Committee. They asked FDA to provide several pieces of information, including agency-wide efforts “to make the finalization of guidance more efficient and expeditious.” We will continue to follow this issue and report as more news becomes available.
The FDA has always dragged their feet on this issue, particularly when it comes to guidance development process, which has been slow, laborious, and a times redundant. Time for a makeover, no question about it. The 1991 Intercenter Agreements are a perfect example – hello FDA – let’s start updating critical material.