FDA Lawyers Blog is pleased to invite you to nominate FDA Lawyers Blog to the American Bar Association’s (“ABA’s”) annual list of the best 100 legal blogs. The short ABA’s Blawg 100 Amici Form may be found here.
Nominations are due no later than September 7, 2012.
Here are the criteria to keep in mind when nominating FDA Lawyers Blog or other legal blogs to the list-straight from the ABA’s website for Amici:
On August 10, 2012, FDA approved Intelliject’s new drug application for Auvi-Q™ (epinephrine) Auto-injector, a device used for the emergency treatment of life-threatening allergic reactions, or anaphylaxis. Anaphylaxis is a severe whole-body reaction to an allergen, characterized by difficulty breathing/wheezing, reductions in blood pressure and pulse, hives/itchiness, swelling of the face, among other symptoms. Anaphylaxis occurs very rapidly, often within seconds or minutes of exposure, and can result in death without prompt medical attention. Epinephrine is the only first-line treatment for anaphylaxis, based on its ability to regulate heart rate, blood vessel and airway passage diameters, and metabolic shifts.
Currently, the EpiPen® Auto-injector is the most prescribed treatment for severe allergic reactions and anaphylaxis, with a market share of more than 95%. However, close to two thirds of patients and caregivers do not carry EpiPens® at all times as directed. Further, many patients have concerns that others will not know how to use EpiPens® in an emergency situation. Other epinephrine auto-injectors, similar in shape to EpiPen®, include Twinject®, Adrenaclick®, and Anapen®.
Unlike the currently-available auto-injectors, Auvi-Q™ is the size and shape of a credit card, and it is as thick as a smartphone, making it small enough to fit in a pocket or a small purse. In addition, Auvi-Q™ is the first epinephrine auto-injector to provide both audio and visual instructions to direct a user how to properly use the device. Intelliject’s goal for AuviQ™ was to make it easy to carry and easy to use. Continue reading
Now in its second year, ACI’s FDA Boot Camp – Devices Edition has been designed to give products liability litigators, as well as industry in-house counsel, federal and regulatory affairs professionals, and life sciences investment and securities experts, a strong working knowledge of core FDA competencies. Learn from an experienced faculty of FDA regulatory attorneys whose sole purpose is to provide you with the information you need to remain compliant and in command. Don’t wait until 2013 to hone your practice and to hear from a stellar faculty, led by a “who’s who” of the nation’s leading medical device regulatory lawyers, who will help you understand:
The basics of the application and approval processes, including 510(k) clearance and PMAs
The complexities of device regulations
The structure of the FDA and the roles of the three major agency centers: CDER, CBER, and CDRH
A practical working knowledge of clinical trials and IDEs
How devices are classified, monitored, and regulated
The pivotal role of labeling and learn how to avoid misbranding and off label promotion
The importance of cGMPs and QSRs to the post-approval regulatory process
The protocols of adverse events monitoring, product withdrawals, and recalls
Attend the pre-conference workshop to seamlessly join the FDA regulatory law discussions at the main conference. The perfect primer to accompany FDA Boot Camp, the pre-conference workshop: Fundamentals of FDA Device Regulatory Law, provides the FDA law refresher course essential to getting the most benefit from the main conference program. Continue reading
On August 21, FLH Partner Brian J. Malkin was quoted in an FDAnews Article on a August 17 ruling refusing to stay a ruling regarding a settlement for K-Dur® 20 (potassium chloride) that was found to be presumptively anticompetitive. As part of the settlement in question, Upsher-Smith Laboratories (“Upsher-Smith”) did not agree that the patent-at-issue was valid, infringed, and enforceable, but did agree to refrain from marketing its generic potassium chloride supplement or any similar product until September 1, 2001, when it would receive a non-royalty, non-exclusive license under the patent to make and sell its generic version. Upsher-Smith also granted the innovator, Schering-Plough Corporation (“Schering-Plough”) a license to several Upsher-Smith products, including Niacor-SR, a sustained niacin product. Schering-Plough also agreed to pay Upsher-Smith $60 million over three years plus additional royalties depending on its sales of Niacor-SR. After the settlement, however, Schering-Plough abandoned its plans to market Niacor-SR.
Specifically, the finder of fact must treat any payment from a patent holder to a generic patent challenger who agrees to delay entry into the market as prima facie evidence of an unreasonable restraint of trade, which could be rebutted by showing that the payment (1) was for a purpose other than delayed entry or (2) offers some pro-competitive benefit.
For more background on this case, please see one of our blogs here.
Prior to the proposed TEST Act, under the Food and Drug Administration Amendments Act of 2007 (“FDAAA”), most United States-conducted interventional clinical trials were registered at ClinicalTrials.gov, and most of the results of those clinical studies were eventually published. However, loopholes in the requirements of the FDAAA resulted in clinical studies that were either not registered, that failed to report results, or both. There are a number of clinical trials, therefore, that are not registered in the publically-accessible database.
The TEST Act will require all interventional biomedical studies conducted on humans to be registered on ClinicalTrials.gov prior to enrolling any patients. In addition, sponsors of these clinical trials will be required to post the study results and other required information on ClinicalTrials.gov within one year of the completion date of the trial. According to the proposed legislation, interventional studies include all human studies where patients are assigned, via protocol, by an investigator to receive specific intervention where the effects of such intervention on biomedical or health-related outcomes are evaluated. For clinical trials involving drugs or medical devices that have never been approved for any use, the TEST Act permits a delayed results submission of up to two years from the date of completion of the clinical trial. Continue reading
The U.S. Court of Appeals for the Federal Circuit recently rendered a follow-up ruling on remand from the Supreme Court’s April 2012 decision regarding Orange Book use codes for method-of-use patents Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S. The Federal Circuit held, in a July 30 ruling, that: (i) a district court can issue a mandatory injunction requiring the owner of the NDA for the brand product to correct a use code which inaccurately describes the FDA-approved, patented use, but (ii) the court must first give the NDA holder the opportunity to correct the use code, rather than direct the company to use precise language for the code.
Nevertheless, the Circuit went on to state: (i) the NDA holder does not have “unbounded discretion” in proposing a new use code, and (ii) the district court has the power to construe the scope of the patent claims and provide limits on the appropriate scope of the corresponding use code. If the court determines that the new code is inaccurate and/or overbroad, the judge at that point can correct the error.
This latest development comes in the wake of the U.S. Supreme Court’s decision arising from Caraco’s proposed section (viii) labeling carve-out for use of the diabetes drug repaglinide (on which we have previously reported here, for example). The patent at issue claimed use of repaglinide in combination with the drug metformin. Caraco wanted to omit the combination therapy, and label its generic version to treat diabetes with repaglinide only. Novo Nordisk admitted that the patent did not cover the use of repaglanide alone, but then changed its use code in the Orange Book to wording that was broad enough to cover repagalanide alone. Continue reading
On August 3, a jury in the U.S. District Court for the District of Massachusetts found Genzyme’s U.S. Patent Number 7,931,030 (“the ‘030 patent) was both not infringed by Seikagaku Corp. and its U.S. distributor, Zimmer Inc., and invalid as obvious in light of the prior art.
Genzyme obtained FDA approval in February 2009 to market Synvisc-One®, an injectable hyaluronic acid gel to treat osteoarthritic pain in the knee. According to Genzyme, Synvisc-One® was an improvement over prior treatments since only one injection of Synvisc-One® was required at least every six months compared to existing drugs that require three injections one week apart for similar pain relief. Synvisc-One® was the only single injection treatment until the FDA approved Gel-One®, a similar treatment also containing hyaluronic acid produced by Seikagaku, in March 2011. One month later, Genzyme filed a complaint alleging that Gel-One® infringed U.S. Patent Number 5,399,351 (“the ‘351 patent”). Genzyme then amended its complaint to add the ‘030 patent to the suit in June 2011 and agreed to drop claims concerning the ‘351 patent in February 2012.
There has been an increased effort to increase pediatric testing for adult medications, due to the expense of pediatric clinical trials and parent concerns about participation. For example, an alarming 70 percent of medications prescribed for children have never been tested on them, the National Institute of Health (“NIH”) estimates.
In an effort to address the issue, on July 9, 2012, President Barack Obama reauthorized the “Best Pharmaceuticals for Children Act” and “Pediatric Research Equity Act” providing drug companies with a six month period of “pediatric exclusivity” if they perform studies approved by the FDA. This approval is a main proponent in easing parents’ minds when allowing their own children to participate in clinical trials. In addition, such initiatives have helped incentivize sponsors to conduct more pediatric research with NIH funding for pediatric research rising by 18% “from $2.77 billion in 2008 to $3.28 billion in 2011.
Yesterday, FLH Partner Brian J. Malkin was quoted in a MedPage Today article by Washington Correspondent David Pittman on a GPhA Study that also published yesterday entitled: “Savings $1 Trillion Over 10 Years: Generic Drug Savings in the U.S. (Fourth Annual Edition: 2012)“. According to the Report, generic drug use has saved the U.S. health care system approximately $1.07 trillion over the past decade (2002 through 2011) with $198.8 billion in savings in 2011 alone. The GPhA Report in turn referenced a number of recent positive analyses of the generic industry, asking Congress not to change the innovator-generic incentives or restrict the use of generics, with a promise for delivering generic biologicals in the future.
Along these lines, MedPage Today attributed Malkin with the following statements:
Changing the 5-year exclusivity period for traditional small-molecule drugs or the 12-year exclusivity for biologics is unlikely, Brian Malkin, drug industry attorney and partner with Frommer Lawrence & Haug in Washington, told MedPage Today in an interview.
“It’s an election year; maybe they’re trying to position themselves for the future,” Malkin said of Thursday’s GPhA report. The savings analysis seemed to be mostly about creating awareness and generating good will for future policy decisions, he said.
For instance, seeking to dissuade a Health Affairs article in November 2011 that stated generic drug usage has increased at a rate that has discouraged the development of new drugs, the GPhA Report highlighted a recent IMS report in April 2012 that found: “…[A]though generic utilization has reached new levels, more new medicines were launched in 2011 that in any other year of the past decade … since the implementation of Hatch-Waxman, there has been a multiple-fold increase in the innovation of new medicines.” The GPhA Report observed: “By creating a fair balance between innovation of new medicines and accessibility to lower cost generic medicines, federal law has established a win-win for providers and American consumers.” Continue reading
Over the past 8 years, thousands of your fellow legal professionals – from Associates to Partners to GCs have relied on ACI’s FDA Boot Camp Conference to provide them with both a comprehensive overview of the basics of FDA law and current information on the status of regulatory law in the pharmaceutical, biotechnology, and medical device industries. We hope that this time you will be able to join your peers as this unique event returns to Boston in September.
Learn FDA regulatory basics from the experts–a veritable Who’s Who of the FDA Regulatory Bar–and save the calls to regulatory counsel for the really complicated questions. Come, hear, and learn from a stellar faculty of the nation’s leading food and drug lawyers, who will explain:
• The application and approval processes for drugs, biologics, and devices • The regulatory balance between brand name and generic products • The complexities of the patent and IP landscape, including Hatch-Waxman, Orange Book, 180-day exclusivity, 30-month stay, Paragraph IV, NDA, ANDA and 505(b)(2)