By Kurt R. Karst – It’s about that time of year again when we do some number crunching and take stock of the year that was in orphan drug designations and approvals. And what a year it was! FDA not only approved a record 26 marketing …
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Prescription Drugs and Biologics
- The Year of the Orphan; Orphan Drug Designations and Approvals Hit All-Time High in 2011February 8th, 2012
- DC District Court Grants FDA Summary Judgment in Generic LOVENOX DisputeFebruary 7th, 2012
By Kurt R. Karst – On February 7, 2012, Judge Amy Berman Jackson of the U.S. District Court for the District of Columbia issued her decision in the long-running dispute concerning FDA’s July 23, 2010 approval of Sandoz Inc.’s (“Sandoz’s”) ANDA No. 077857 for a generic version …
- Drug Shortage Prevention Act Seeks to Improve Communication and Expedite Review of Drugs in ShortageFebruary 3rd, 2012
By Kurt R. Karst – Earlier this week, Representatives John Carney (D-DE) and Larry Bucshon (R-IN) introduced H.R.3839, the “Drug Shortage Prevention Act,” which, according to its sponsors, is intended to bring “more efficiency to the manufacturing and distribution processes” and to require “FDA to …
- GAO Report Criticizes FDA on Antibiotic Labeling; Finds No Evidence of Encouraged InnovationFebruary 1st, 2012
By Kurt R. Karst – A new report released by the Government Accountability Office (“GAO”), titled “Antibiotics: FDA Needs to Do More to Ensure That Drug Labels Contain Up-to-Date Information,” says that since the September 27, 2007 enactment of the FDA Amendments Act (“FDAAA”) FDA has …
- PTO Challenged After Denying a Patent Term Extension Based on First Commercial Marketing or Use GroundsJanuary 31st, 2012
By Kurt R. Karst – The U.S. Patent and Trademark Office (“PTO”) has been sued once again after denying a Patent Term Extension (“PTE”) request. The latest case in a long line of lawsuits concerns U.S. Patent No. 5,206,248 (“the ‘248 patent”), which is listed in …
- A New Hatch-Waxman DJ Jurisdiction Decision . . . . And an Added TwistJanuary 24th, 2012
By Kurt R. Karst – In a recent Hatch-Waxman decision from the U.S. District Court for the Northern District of Illinois (Eastern Division), the court denied Plaintiffs’ Seattle Children’s Hospital, Novartis Vaccines and Diagnostics, Inc., and Novartis Pharmaceuticals Corporation (collectively “Novartis”) Motion to Dismiss the lawsuit …
- Leap Year and Hatch-Waxman – An Unusual Conundrum Years in the MakingJanuary 23rd, 2012
By Kurt R. Karst – It’s absolutely amazing how, after nearly 28 years, the 1984 Hatch-Waxman Amendments continue to provide surprises. Consider the latest example we came upon recently (with a little help) involving PRISTIQ (desvenlafaxine) Extended-Release Tablets. FDA approved PRISTIQ under NDA No. 021992 in a …
- HP&M to Host Webinar on the FDA Appeals ProcessJanuary 19th, 2012
Pharmaceutical and medical device applicants faced with an adverse decision from FDA (e.g., regarding data requirements, study design, or regulatory pathway) may dispute that decision through multiple routes. The appeal processes in both CDER and CDRH offer numerous strategic and procedural advantages that, when used …
- ACI’s FDA Boot Camp ConferenceJanuary 19th, 2012
The American Conference Institute will be holding its FDA Boot Camp conference in New York City from Tuesday, March 20 to Wednesday, March 21, 2012. A copy of the conference program can be obtained here. Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst will be …
- FDA Sends User Fee Pacts to Congress; Proposed Generic Drug User Fee Statute Includes Some Unique ProvisionsJanuary 18th, 2012
By Kurt R. Karst – Last week, FDA Commissioner Margaret A. Hamburg, M.D. announced that the Agency sent to Congress packages for three user fee programs, including proposed statutory language for the fifth iteration of the Prescription Drug User Fee Act (“PDUFA V”), and two new …
- FDA Denies Petition Seeking to Add Application Information to Drug LabelsJanuary 12th, 2012
By Kurt R. Karst – FDA recently denied a 2008 citizen petition (Docket No. FDA-2008-P-0291) requesting that the Agency amend its drug label regulations to require that product labels include the Orange Book-listed NDA number under which the product is approved. According to the petition, “[i]ncreasingly, …
- “Size Matters,” Says FDA, When it Comes to Generic Drug-RLD SamenessJanuary 4th, 2012
By Kurt R. Karst – In what appears to be a further sign of FDA’s efforts to clamp down on differences between brand-name Reference Listed Drugs (“RLDs”) and their proposed generic counterparts, FDA’s Office of Generic Drugs (“OGD”) is now looking more closely at tablet size …
- ULTRA Bill Introduced in the House; Legislation Seeks to Permit Broader Use of Scientific Data to Support Surrogate Endpoints for “Ultra Orphan” Drug ApprovalsJanuary 2nd, 2012
By Kurt R. Karst – Representatives Cliff Stearns (R-FL) and Ed Towns (D-NY) recently introduced H.R. 3737, the Unlocking Lifesaving Treatments for Rare-Diseases Act (“ULTRA”). The bill would amend the FDC Act to “improve access to the existing accelerated approval pathway for patients with life threatening …
- GAO Report Finds That FDA Needs Increased Authority to Address ShortagesDecember 19th, 2011
By Jennifer M. Thomas – A Government Accountability Office (“GAO”) Report released on December 15, 2011, the same day as a Senate Committee hearing, finds that FDA needs increased authority in order to address the growing problem of drug shortages. In her statement before the Senate …
- Revelations: FDA’s Perspective on Drugs Marketed Pursuant to a Pending DESI Proceeding and the Unapproved Drugs CPGDecember 14th, 2011
By Kurt R. Karst – We had hoped that our post from earlier this week, titled Pending DESI Program Proceedings – The List, would stimulate some discussion. And it did. One comment in particular that we received from an authoritative source caught our attention and deserves greater …