By Kurt R. Karst – It’s been a long time since we last posted on a Patent Term Extension (“PTE”) controversy – a little more than a year it seems (see here) – but that doesn’t mean we’re not keeping an eye on decisions coming out …
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Prescription Drugs and Biologics
- A New Variation on an Old Theme: FDA Refuses PTE Regulatory Review Period Revision Based on Filing Refusal DecisionFebruary 24th, 2015
- FDA Officially Releases Four Compounding Draft Guidance Documents and Its Draft Memorandum of Understanding; Part Two: FDA Provides Details on the Draft Standard MOUFebruary 20th, 2015
By Karla L. Palmer – Following our blogpost describing the four human drug compounding draft guidance documents and draft Memorandum of Understanding (MOU) that FDA released last Friday, FDA formally published the documents in the Federal Register on February 19th. Interested persons should note the docket …
- Would You Balk at Disclosing Confidential Information to Your Competitors?February 18th, 2015
By Kurt R. Karst – Without even knowing what we’re talking about, it’s probably safe to say that any company would immediately answer “Yes!” to the question posed in the title to this post. But that’s exactly what FDA is asking some ANDA applicants to do …
- Can the AIA’s New IPR and PGR Post-Grant Proceedings Trigger a Forfeiture of 180-Day Exclusivity Under the Failure-to-Market Provisions?February 17th, 2015
By Kurt R. Karst – Last year we posted on the possible effect of Inter Partes Review (“IPR”) on the forfeiture of 180-day exclusivity eligibility under the so-called failure-to-market forfeiture provisions at FDC Act § 505(j)(5)(D)(i)(I) added by the 2003 Medicare Modernization Act. With no decision …
- Another Holiday Surprise: FDA Releases Four Draft Guidances and a Draft Memorandum of Understanding Related to Drug CompoundingFebruary 17th, 2015
By Karla L. Palmer – As it did on the eve of another holiday weekend last July (see our previous posts here and here), on this past Friday (the 13th), FDA released the long-awaited draft Memorandum of Understanding (MOU) addressing interstate shipment of compounded preparations under …
- The 2014 Numbers Are In: FDA’s Orphan Drug Program Shatters RecordsFebruary 16th, 2015
By Kurt R. Karst – Earlier this month in a post concerning the Orange Book we mentioned our love of data and discussed how solid figures can reveal some interesting conclusions. After all, it’s rather difficult – and dangerous – to come to a conclusion without …
- This Just In: NIH Extends the Comment Period for its Proposed Rule on Clinical Trials Registration and Results ReportingFebruary 15th, 2015
By James E. Valentine* & Anne Marie Murphy – The National Institutes of Health (“NIH”) just extended the comment period for its Notice of Proposed Rulemaking on clinical trial registration and results submission (“NPRM”) until March 23, 2015. As we previously reported, the NPRM proposes to …
- We Need to Move the Freight and Not be Late, Says OGD’s Uhl in GDUFA Update; But for Many in Industry, “Seeing is Believing”February 13th, 2015
By Kurt R. Karst – For those in the generic drug industry who attended the Generic Pharmaceutical Association’s (“GPhA’s”) annual meeting in Miami, Florida earlier this week, the message from Office of Generic Drugs (“OGD”) Director Dr. Kathleen “Cook” Uhl in her Generic Drug User Fee …
- FINALLY! Multiple Generic Companies Receive FDA Final Approval to Market Generic Versions of Celebrex®February 12th, 2015
By Douglas B. Farquhar, Jennifer M. Thomas & Kurt Karst – We can’t help celebrating a recent court victory in which Hyman, Phelps & McNamara, P.C. represented Mylan Pharmaceuticals, Inc. (“Mylan”), and which yesterday resulted in Final Approvals for Mylan and one other generic drug company …
- FDA Draft Guidance on Disclosing Risk Information Discourages Companies From Meeting Current Regulatory RequirementsFebruary 10th, 2015
By Dara Katcher Levy – Last Friday, FDA issued the latest in a series of draft guidance documents (here and here) that address alternate ways companies can disclose risk information in consumer-directed print Rx drug promotion. The most significant difference between the 2015 and 2004 draft …
- The 21st Century Cures Act: Putting Patients First, Literally and … Substantively (And FDA’s New Expanded Access Form)February 9th, 2015
By James E. Valentine* & Jim C. Shehan – The 21st Century Cures Act’s focus on patients is inescapable. Title I of this nearly 400 page bill is entitled, “Putting Patients First By Incorporating Their Perspectives Into The Regulatory Process and Addressing Unmet Needs.” When we reported …
- Diary of a Hatch-Waxman Addict – Day 4,079: They’re Here! FDA Finally Proposes Regulations to Implement Some of the Provisions of the 2003 MMA!February 5th, 2015
By Kurt R. Karst – There was some big news out of FDA today. Yes, there was the news that FDA Commissioner, Dr. Margaret Hamburg, one of the longest-serving FDA commissioners in the modern era (see here), has decided to resign her post effective next month. …
- Is the MIA DOA? Bill to Assess Fees on Top of Settlements Doesn’t Receive Bipartisan LoveFebruary 5th, 2015
By James C. Shehan – The new Congress has been very busy introducing legislation that affects FDA and regulated industry, including the 21st Century Cures Act (see our previous post here); the Limited Population Pathway for Antibacterial Drugs Act (PATH) (here) and the Improving Regulatory Transparency …
- Mining the Bowels of the Orange Book: What Do the Data Reveal?February 4th, 2015
By Kurt R. Karst – There’s no two ways about it: We love data. And it doesn’t really matter what FDA-related topic those data concern: citizen petitions (here and here), drug patent settlement agreements (here), user fees (here), orphan drugs (here), or just general FDA regulation …
- IOM and Congress Press On to Expand Clinical Trials Data Sharing, Despite Ongoing NIH RulemakingFebruary 1st, 2015
By James E. Valentine* & Anne Marie Murphy – The first month of 2015 has seen two policy proposals that would expand clinical trials data sharing. On January 14, the Institute of Medicine (“IOM”) released its report on “Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risks,” …