Biosimilars, user fees and drug shortages are three issues dominating the dialogue in the US generic drug regulatory arena, and FDA, Congress, industry and public interest groups are all very much caught up in the complexities of addressing them. The Monthly Update has stories on each of the three issues in turn.
Prompting the IPQ coverage was FDA’s much-anticipated release of its draft biosimilars guidances and a Congressional hearing the same day at which the agency and industry testified and fielded questions on generic drug and biosimilar user fees. The hearing also focused on the growing problem of drug shortages and what can be done to forestall them.
The other major theme in this Month’s Update is consent decrees – what causes them, how they are shaped and the long wake of their repercussions.
Included is an analysis by a knowledgeable lawyer who has represented both government and industry in consent decree negotiations and related litigation.
A second story focuses on the decree recently signed by India’s largest generic drug manufacturer Ranbaxy and its significance in addressing data integrity problems along with GMP issues and sending up a global red flag on fraudulent filings.
A third story flowed out of the announcement by Genzyme of the opening of its new biotech plant as part of the firm’s return to full production after a significant virus contamination and a GMP consent decree.  The announcement prompted a review of last year’s watershed PDA/FDA adventitious virus conference and the revelations that emerged from the struggles with virus production outbreaks at not only Genzyme but at other biotech manufacturers including Amgen and Merrimack. The story includes insights from CDER’s Barry Cherney and other regulators on how regulatory expectations for virus control are advancing with the science and technology.
The February Monthly Update also covers new developments in the effort by governmental agencies and industry associations to address the reliability and integrity of the drug supply chain.
On the European front, EDQM formally launched its “eTACT” anti-counterfeiting traceability service. eTACT represents a major initiative by European regulators to create a track-and-trace system that will span all of Europe and cover both Internet and in-person purchases.
In the international GDP arena, IPQ provides coverage of two contributions to the guidance library addressing the evaluation and handling of excipient distribution: ● a draft of a new general chapter from USP, and ● a new version of IPEC’s excipient audit guideline.
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