Indian pharma expects US FDA’s SUPAC Mfg Eqpt Addendum to boost global regulatory compliance

Policy & Regulations

Nandita Vijay, Bengaluru Friday, April 12, 2013, 08:00 Hrs [IST]

The Indian pharma industry expects the US FDA's recently released SUPAC (scale-up and post-approval changes): Manufacturing Equipment Addendum will further give fillip to faster clearances in plant audit and product approval. After releasing the Addendum, the US regulatory authority is seeking comments from the pharma industry before June 30, 2013. India already has over 170 US FDA approved units and has bagged 178 Abbreviated New Drug Applications (ANDAs) in 2012 which is over 34 more than the 2011. These include companies from Aurobindo to Biocon, Dr Reddy’s Labs, Lupin, Sun, Indoco Remedies, Ranbaxy and Strides Arcolab. Now with a strong focus for generic drug prescriptions from the governments of US, European Union and Japan, there are many Indian companies exporting to these markets. Therefore the new draft guidelines on scale-up and post-approval changes: Manufacturing Equipment Addendum will only strengthen compliance to the global regulator’s requirements, said representatives from pharma industry. The draft guidance combines the scale-up and post-approval changes for industry for the immediate release and modified release solid oral dosage forms and non-sterile semisolid dosage forms. It removes the lists of manufacturing equipment that were in both guidance and clarifies the types of processes being referenced.

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The Other Shoe Drops: ViroPharma Sues FDA – Challenges Denial of 3-Year Exclusivity and ANDA Approvals, from FDA Law Blog

By Kurt R. Karst –     

Last Friday, ViroPharma Incorporated (“ViroPharma”) filed a Complaint and a Motion for Temporary Restraining Order And/Or Preliminary Injunction in the U.S. District Court for the District of Columbia challenging FDA’s approval of three ANDAs for generic versions of ViroPharma’s VANCOCIN (vancomycin HCl) Capsules (Case No. 1:12-cv-00584-ESH).  The lawsuit follows FDA’s April 9, 2012 response to a March 2006 petition for stay of action submitted by ViroPharma (and supplemented on several occasions since).  FDA largely denied ViroPharma’s requests and approved ANDAs for generic VANCOCIN (see our previous post here).  FDA determined that the Agency “has clear legal authority to recommend in vitro dissolution data to demonstrate generic vancomycin bioequivalence,” and that a December 2011 supplemental NDA FDA approved for VANCOCIN is not eligible for 3-year exclusivity because of the limitation on such exclusivity for a so-called “old antibiotic” like vancomycin set forth in FDC Act § 505(v) as added by Section 4 of the 2008 QI Act.

According to ViroPharma, FDA violated the Administrative Procedure act (“APA”) “by adopting and applying in vitro dissolution testing as the bioequivalence testing method for vancomycin, in direct conflict with the FDA’s own regulations, and by basing its approval of the three generic vancomycin ANDAs on this improper in vitro testing.”  In approving ANDAs for generic VANCOCIN, says ViroPharma, “FDA did not follow its own rules, the plain text of which require that bioequivalence be established through in vivo testing absent a waiver unavailable under the circumstances at issue here.  Accordingly, the agency’s ‘deviant action’ must be invalidated.”   FDA’s regulations at 21 C.F.R. Part 320 discuss the various requirements for bioequivalence testing, including the various types of tests available to meet in vivo or in vitro requirements. “Nowhere in § 320.22, or anywhere else in the regulations, does it state that FDA has discretion to approve ANDAs based solely on in vitro testing whenever it chooses and regardless of whether any of the circumstances in § 320.22 are satisfied,” says ViroPharma.

With respect to FDA’s denial of 3-year marketing exclusivity, ViroPharma alleges that FDA violated the APA and the FDC Act (§ 505(c)(3)(E)(iv) & § 505(j)(5)(F)(iv)).  According to ViroPharma:

FDA erred in concluding that every one of the recent fundamental and extensive changes to Vancocin’s labeling constitutes a “condition of use for which” Vancocin “was [previously] approved.”  To the contrary, virtually all of those changes, including in particular the new renal monitoring and dosing requirements, constitute new conditions of use not previously approved, and ViroPharma is therefore entitled to three-year exclusivity (running from December 14, 2011, to December 15, 2014) for its new label.  Critically, even if just one of Vancocin’s labeling changes qualifies for exclusivity, then the entire basis for the FDA’s rejection of exclusivity and hence for approving the generic vancomycin ANDAs is undermined.

more... http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2012/04/the-other-shoe-drops-viropharma-sues-fda-challenges-denial-of-3-year-exclusivity-and-anda-approvals.html