In the latest attempt to show a concerned Congress and the general public that it is taking action on drug shortages, FDA’s Center for Drug Evaluation and Research (CDER) has raised the organizational profile of its 11-member staff devoted to the subject, moving them into the Office of the Center Director.

The move follows an internal CDER memo made public earlier this month in which Center Director Janet Woodcock said she would be announcing organizational changes “to sharpen the Center’s focus and strengthen resources around pharmaceutical quality,” as the memo about the drug shortages change summarizes it. Other changes so far have included the promotion of the Office of Generic Drugs to “super-office” status Also see "Generic Drugs Gain Status Boost Within CDER" - Pink Sheet, 7 September, 2012..

The transfer of the Drug Shortages Staff, referred to as the “Drug Shortages Program” in FDA’s web page “Frequently Asked Questions About Drug Shortages,” moves it from the purview of the Office of New Drugs and its Director, John Jenkins, to that of the Office of the Center Director’s Deputy Director for Regulatory Programs, Doug Throckmorton.

FDA Under Pressure To Resolve Shortages

The memo notes that the Food and Drug Administration Safety and Innovation Act that President Obama signed into law in July, and that included the reauthorization of the agency’s user fee programs, “provided FDA with new authorities to combat shortages of drug products in the United States and imposed new requirements on manufacturers regarding early notification to FDA of issues that could lead to a potential shortage or disruption in supply of a product” ([A#00120716007]).

Specifically, the law requires manufacturers to notify FDA at least six months before a production interruption or stoppage if they know about it in advance, although there is no fine for noncompliance Also see "Importation Should Be Preemptive Tool During Shortages, Group Tells FDA" - Pink Sheet, 2 July, 2012.. For its part, the agency is now empowered to expedite reviews of manufacturing and other supplements to avert or mitigate a shortage Also see "FDA Spending Less Time On INDs, More On NDAs and BLAs" - Pink Sheet, 6 August, 2012..

The drug shortage staff, which has increased from three to 11 employees in the past few years, helped prevent 195 drug shortages in 2011 and another “close to 100 shortages” through August 2012. However, FDA listed 120 drug products as being in shortage as of Sept. 28.

The subject has also led to something of a PR blitz at FDA, which featured Commissioner Margaret Hamburg at a February press conference Also see "FDA Drug Shortage Strategy: Enforcement Discretion, Patient Public Relations" - Pink Sheet, 21 February, 2012.. This is not surprising in light of pressure on the agency that has included Congressional hearings Also see "Drug Shortage Legislation: Sen. Blumenthal Calls For More Extensive Effort" - Pink Sheet, 30 March, 2012..

Throckmorton’s briefcase was already bulging before the addition of oversight of the drug shortage staff. For example, in the past year he has spoken publicly about such diverse subjects as the use of opioids to treat chronic non-cancer pain, cardiovascular safety information required for diabetes drugs, and FDA’s use of advisory committees in drug approvals (Also see "Disease-Of-The-Quarter Club: FDA Plans 20 Patient Network Meetings Over Five Years" - Pink Sheet, 18 June, 2012., Also see "The Inevitable Outcome: Diabetes Safety Model Expands To Weight Loss…And Beyond?" - In Vivo, 23 May, 2012., and Also see "FDA Approving More Novel Drugs Without Advisory Committee Review" - Pink Sheet, 23 January, 2012.).

FDA Drug Shortage Staff Gets Higher Profile As New Reporting Requirements Begin

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