FDLIBrazil.jpgFLH Partner Charles J. Raubicheck, head of our firm’s FDA/Regulatory practice, will moderate a panel and deliver an address at the upcoming Food and Drug Law Institute’s Conference “U.S. & Brazil: Navigating New Frontiers in Pharmaceutical, Medical Device and Food Law and Regulation.” The conference will be held on September 10-11, 2012 in São Paolo, Brazil.

Brazil has the world’s 6th largest economy, and is becoming a leader in research and development in the drug, medical device and food industries. The Conference is a forum for representatives of companies, venture capital firms, government agencies, law firms and other interested groups to focus on business opportunities and regulatory hurdles in both Brazil and the U.S. Speakers will include officials of FDA and the Brazilian National Health Surveillance Agency (“ANVISA”).

Thumbnail image for pediatrics.jpgThe Pediatric Committee (“PDCO”) of the European Medicines Agency (“EMA”) is tasked with identifying the needs for children in a variety of therapeutic areas and aims to encourage the research and development of pediatric medicinal products. The first Inventory, which is now open for discussion and public consultation, covers medicines for cardiovascular diseases. The EMA points out that it will be releasing similar lists for other therapeutic areas for public consultation during 2012 and 2013.

According to the EMA, the Inventory aims to enable:

  • Companies to identify opportunities for business development;
  • The PDCO to judge the need for medicines and studies when assessing draft pediatric investigation plans, waivers and deferrals; and
  • Healthcare professionals and patients to have an information source available to support their decisions as to which medicines.

The Inventory is based on a report on the survey of all pediatric uses of medicinal products in Europe completed by the PDCO in December 2010.
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Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for drugmoney.jpegOn August 27, FDA published a Federal Register notice announcing the availability of industry guidance for generic drug user fees entitled “Generic Drug User Fee Amendments of 2012: Questions and Answers” and “Self-Identification of Generic Drugs Facilities, Sites, and Organizations.” Simultaneously with this notice, FDA also announced an upcoming public meeting on September 21, 2102 from 9 a.m. to 1 p.m. to discuss FDA’s implementation of the Generic Drug User Fee Amendments of 2012 (“GDUFA”). Finally, on the same day, another related Federal Register Notice issued: “Notice of Opportunity to Withdraw Abbreviated New Drug Applications to Avoid Backlog Fee Obligations.” Below is a snapshot of each of these items taken in turn.

GDUFA was signed into law on July 9, 2012 but the obligations arising therein begin on October 1, 2012. We have previously blogged on the genesis of GDUFA, when both the House and Senate passed GDUFA, for some background why and how we got here.

The GDUFA Q&A answers questions about the various types of fees (backlog fee, drug master file fee, generic drug submission fees (including a fee for active pharmaceutical ingredients (“APIs”) not referenced in a drug master file), and facility fees for APIs and finished dosage forms (“FDFs”)), self-identification of facilities, sites, and organizations, review of generic drug submissions, and inspections and compliance. For example, most immediately, backlog fees will be calculated based on the number of pending original abbreviated new drug applications (“ANDAs”) at the start of October 1, 2012. As was mentioned in a recent conference discussing this topic, a recommendation was made for all generic applicants to “clean house” and make sure that they did not pay fees for any pending ANDAs that they were no longer pursuing. FDA explains in this Notice that in accordance with GDUFA, FDA will divide $50 million by the number of pending ANDAs pending on this day to arrive at an individual one-time backlog fee due for each pending ANDA. Applicants wishing to remove pending ANDAs from this list, however, must do so by written notification received by FDA on or before September 28, 2012. Failure to pay the backlog fee is further explained, including a public disclosure of the failure to pay, and FDA will not receive a new ANDA or supplement submitted by that applicant “or affiliate” until the fee is paid. The GDUFA Q&A also explains when the various fees will be collected and the effect of not paying those fees timely. For new ANDAs or supplements, feed need to be paid when due, e.g., for new ANDAs, within 20 calendar days of the date that FDA provides notification that failure to pay will result in the ANDA or supplement not being receive and, therefore, reviewed.
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APPlogo2.pngFDA 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®.

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Written by Julie E. Kurzrok

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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.
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Thumbnail image for Thumbnail image for aci_header_banner.gifNow 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.
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Thumbnail image for Money in hand.jpgOn 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.

The Third Circuit originally held:

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.

Thumbnail image for 3699948229_d7732f8df0_o.jpgOn August 2, four members of the House of Representatives, led by Congressman Edward Markey, introduced, H.R. 6272, “The Trial and Experimental Studies Transparency (TEST) Act of 2012.” The TEST Act will amend Section 402(j) of the Public Health Service Act, tightening the reporting requirements for the Internet site designed to better inform the public about ongoing and completed clinical trials in the United States, ClinicalTrials.gov. The main goal of the TEST Act is to prevent clinical-trial sponsors from withholding negative study data and safety concerns while emphasizing the positive results of their clinical trials.

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.

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Written by Julie E. Kurzrok

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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.
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Thumbnail image for Thumbnail image for Thumbnail image for federalcircuit.jpgThe 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.
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knee.jpgOn 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.

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Written by Shelly Fujikawa, Ph.D.