FDA could resuscitate its Pharmacy Compounding Drugs Advisory Committee in the wake of the fungal meningitis outbreak linked to compounded steroid injections produced by the New England Compounding Center.

The panel has been defunct since FDA announced its termination in November 2002 Also see "FDA Advisory Committee Line-Up Shrinks With Elimination Of Two Panels" - Pink Sheet, 25 November, 2002..

The tentative 2013 schedule for FDA advisory committee meetings, however, includes the pharmacy compounding panel in its list of Center for Drug Evaluation and Research committees and under dates says “if needed, to be determined.” Similar language for as-yet unspecified dates occurs for six other CDER committees in a Jan. 2 Federal Register notice.

Reconstituting the Pharmacy Compounding Drugs Advisory Committee could facilitate FDA’s acquisition of expert input as it deals with the aftermath of the NECC failure to produce safe products.

Of particular importance is how to define which aspects of compounding are regulated by FDA and which come under states’ jurisdiction as Congress considers whether to enact legislation expanding FDA’s authority in the area ([A#00121119013]).

FDA Commissioner Margaret Hamburg has suggested that states continue to oversee compounding of medications for individual patients while the agency assume responsibility for drugs compounded in high volume without a prescription, the activity that occurred at NECC.

State and FDA officials began discussing their respective roles in regulating compounders during a December meeting ([A#14121220004]).

Vacancies Announcement

The Pharmacy Compounding Drugs Advisory Committee is not included in the list of advisory committees on CDER’s website, but the center’s list of advisory committee vacancies notes there are 13 on the compounding panel. Qualifications for the committee call for members to be “knowledgeable in the fields of pharmaceutical compounding, pharmaceutical manufacturing, pharmacy, medicine and other related specialties.

Re-forming the committee would not be a first for the agency. The Medical Imaging Drugs Advisory Committee was disbanded at the same time as the compounding panel in 2002, but was re-established in May 2011. That panel already has a date for 2013 – Feb. 14 to review Guerbet SA’s gadoterate meglumine injection for magnetic resonance imaging of the brain, spine and associated tissues Also see "Guerbet Looks To Separate Dotarem In Crowded Contrast Agent Market" - Pink Sheet, 3 January, 2013..

The compounding panel originally was created by the FDA Modernization Act in 1997 as part of a section that exempted some compounded drugs from new drug approval and good manufacturing practice requirements. The Ninth U.S. Circuit Court of Appeals ruled two speech-related provisions of that section unconstitutional, bringing down the entire section, a decision essentially upheld by the Supreme Court in April 2002 Also see "Supreme Court Reaffirms Least Restrictive Standard For Ad Controls" - Pink Sheet, 6 May, 2002..

Although FDA announced termination of the panel in response to the court decision, the panel remained on the list of agency advisory committees in the Code of Federal regulations as of April 1, 2012.

FDA documents indicate that before the committee was dissolved, its focus was on assessing drugs for inclusion or exclusion from a list of bulk drugs permitted for pharmacy compounding Also see "FDA To Facilitate 4-AP Compassionate Use INDs For MS, Axelrad Says" - Pink Sheet, 24 July, 2000..

In 2003, an amendment to the Senate legislation creating the Medicare prescription drug benefit would have reestablished congressional authorization of the panel, but the provision failed to make it into law.

Congressional authorization is not required to establish an advisory committee. The head of an agency can establish a committee, after consultation with the Administrator of General Services, if they determine the panel “to be in the public interest in connection with the performance of duties imposed on that agency by law.” Formation of the committee must be announced in the Federal Register.

FDA’s Advisory Committee Schedule Hints At Re-formulated Compounding Panel

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