By Kurt R. Karst – Last week, as Congress, FDA, and industry continue to ramp up debate on what changes or modifications should be made to the FDC Act and PHS Act as part of a user fee package of bills expected to be enacted later …
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Prescription Drugs and Biologics
- A Trio of Reports Discuss the Benefits of the Pediatric “Carrot and Stick” Statutes, the Orphan Drug Act, and Hatch-WaxmanMarch 6th, 2012
- On-Again Off-Again Third Category of Drugs is On Again at FDA; Simultaneous Rx and OTC Marketing Also Up for DebateFebruary 29th, 2012
By Kurt R. Karst – Every few years, interest in the creation of a third category of drug products – something other than prescription or Over-the-Counter (“OTC”) status – is piqued by FDA, Congress, or by some other entity. The most recent attempt to explore the …
- FDA Flexes New Enforcement Muscle; Issues Warning Letter for Failure to Meet Required Postmarketing Study Milestone DatesFebruary 28th, 2012
By Kurt R. Karst – Among the Warning Letters FDA posted on its website this week, one in particular caught our attention – a February 17, 2012 Warning Letter to Merck Sharp and Dohme Corp. (“Merck”) citing a violatation of FDC Act § 505(o)(3). FDA’s enforcement …
- The YASMIN Case: Is it Conceivable (or Not) that Hatch-Waxman Method Patent Infringement Lawsuits are Limited to Information in the “Indications and Usage” Drug Labeling Section?February 22nd, 2012
By Kurt R. Karst – Following the Federal Circuit’s recent precedential decision in AstraZeneca Pharms. v. Apotex et al. (Case No. 2011-1182) (in which the Court held that an ANDA sponsor who submits a “section viii” statement with respect to an Orange Book-listed method-of-use patent and does …
- Seeking a Second Bite at the Apple? Lannett Petitions FDA on the “Grandfather” Status of Morphine SulfateFebruary 20th, 2012
By Kurt R. Karst – Following a long court battle in which a three-judge panel of the U.S. Court of Appeals for the Tenth Circuit affirmed a November 2010 decision from the U.S. District Court for the District of Wyoming granting FDA’s Motion to Dismiss a …
- FDA Wraps Up Responses to 2003 & 2004 Petitions on “Biosimilars”; Denies Outstanding RequestsFebruary 16th, 2012
By Kurt R. Karst – Just days after FDA announced the release of three draft guidances on biosimilar product development (see our previous post here), and on the same day FDA officially noticed their availability in the Federal Register (here, here, and here) (as well as …
- BMJ Article on Clinical Trial Reporting Foments Discontent on Capitol Hill (Our 1,500th Post!)February 15th, 2012
By Kurt R. Karst & David B. Clissold – Three House lawmakers (Reps. Henry Waxman(D-CA), Ed Markey (D-MA), and Diana DeGette (D-CO)) sent letters (here and here) to FDA Commissioner Dr. Margaret Hamburg and NIH Director Francis Collins earlier this week expressing their concern over a …
- Full Circle: Rush Bill Would Make Most Patent Settlement Agreements UnlawfulFebruary 13th, 2012
By Kurt R. Karst – Last week, Representative Bobby Rush (D-IL) announced the introduction of H.R. 3995, the Protecting Consumer Access to Generic Drugs Act of 2012. The bill is the latest piece of legislation that attempts to stymie so-called pay-for-delay patent settlement agreements. In January …
- FDA Releases New Guidance on ClinicalTrials.Gov Statement in Informed Consent DocumentsFebruary 13th, 2012
By Nisha P. Shah – On February 9, 2012, FDA released a new guidance document called, “Guidance For Sponsors, Investigators, and Institutional Review Boards – Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c).” The guidance is intended to help small businesses understand the …
- “Soon” Has Finally Come; FDA Issues Three Highly Anticipated Biosimilars Draft GuidancesFebruary 10th, 2012
By Kurt R. Karst – Within moments of FDA’s (Dr. Janet Woodcock) announcement during the February 9th House Energy and Commerce hearing on generic drug and biosimilar user fees that the Agency would issue draft guidance on biosimilar product development later in the day, Twitter was, …
- The Coda in the ANGIOMAX Symphony; Approaching Fine (the End)February 9th, 2012
By Kurt R. Karst – In music, “coda” is a term used primarily to designate a passage that brings a piece (or a movement, which may be part of a symphony – an extended musical composition) to an end – the “fine.” A coda can be …
- The Year of the Orphan; Orphan Drug Designations and Approvals Hit All-Time High in 2011February 8th, 2012
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 …
- 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 …