CDER reorganizes for global compliance

FDA’s Center for Drug Evaluation and Research has elevated its Office of Compliance and realigned it to focus more on the challenges of an increasingly global pharmaceutical industry.

The compliance office becomes a “super office,” and its divisions become offices themselves under the reorganization, which puts compliance on a par with four other CDER “super offices,” including the Office of Pharmaceutical Science (Also see "CDER’s Drug Integrity Program Gains Formal Role In Compliance Office Reorg" - Pink Sheet, 13 June, 2011.).

With some exceptions, agency officials are acting in the same capacity as before the reorganization. Deborah Autor remains director of compliance under the new scheme, but some of her direct reports change (Also see "CDER’s New “Super-Office” Of Compliance" - Pink Sheet, 13 June, 2011.).

CDER is focusing on global supply chain integrity by adding a new entity, an Office of Drug Security, Integrity and Recalls, to its compliance super office. Its acting director is Michael Levy, formerly director of the compliance office’s New Drugs & Labeling Compliance Division. Kathleen Anderson moves up from the deputy slot to succeed him as director of that division, which is now an office.

Rick Friedman will no longer be director of the Manufacturing & Product Quality unit, which goes from a division to an office. The acting director is Steven Lynn, who had been chief of the division’s Recalls and Shortages Branch.

Friedman joins Steven Wolfgang, Ann Meeker-O’Connell and Meghan Murphy as acting associate directors for risk science, intelligence and prioritization for their respective offices, with Gregg Claycamp serving in that role for the compliance super office.

FDA warns more foreign device makers

FDA’s device center is sending a record number of warning letters to foreign facilities as the agency continues its efforts to more effectively oversee product manufacturing located outside the U.S.

So far this year, the Center for Devices and Radiological Health has sent 22 quality system-related warning letters to non-U.S. facilities – an 83 percent increase over what it issued to manufacturers during the entire 12 months of 2010, a “Silver Sheet” analysis shows.

“The number of warning letters and the attention being paid to foreign manufacturing of devices and device components has increased, and that’s no accident. It’s the result of a number of factors,” CDRH Office of Compliance Director Steven Silverman said (Also see "Warning Letters To Foreign Firms Rise; FDA Inspection Cadre Yields Big Impact" - Medtech Insight, 1 May, 2011.).

Five years of the same top five GMP cites

FDA inspectors cited failure to follow quality control unit responsibilities or put them in writing (21 CFR 211.22) more than any other drug GMP violation over the past five years, according to data the agency recently released.

In fact, the top five drug GMP violations cited in Form 483 reports of inspectional observations were the same each year from 2006 to 2010 (Also see "GMP Violations Are A Consistent But Well-Shuffled Deck, FDA Data Show" - Pink Sheet, 6 June, 2011.).

China’s Anhui model raises GMP concerns

SHANGHAI – Groups representing domestic and international drug makers last month suggested China may be setting the bar too low when qualifying bidders in the winner-take-all competition to supply pharmaceuticals on the country’s Essential Drug List.

China’s Anhui Province developed the highly competitive procurement approach China’s State FDA is adopting, which reduced prices by 30 percent as it spread to other provinces.

But worries about quality increased after China’s SFDA revoked the GMP certification of a big winner under the Anhui model, Sichuan Shuzhong Pharmaceutical, due to GMP violations in the manufacture of two products on the Essential Drug List that inspectors discovered in April (Also see "China Reviews Essential Drug Pricing Model After GMP Violations From Multi-bid Winner" - Scrip, 3 June, 2011.).

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